Why Has Bayer Stopped “Essure” Use In The UK and EU? Is it because women need a hysterectomy to remove the birth control device?

By Mark A. York (September 19, 2017)

Mass Tort Nexus

“Women are forced to undergo hysterectomies to remove a birth control device, Essure which is manufactured and marketed by Bayer AG, according to the British Medical Review Board”

 

 

 

 

 

 

The Essure birth control implant is used to permanently sterilize women, but is now recognized as a cause of significant side effects and complications also known in the healthcare industry as “adverse events” with the United Kingdom and European Union now restricting use of the permanent birth control device. This action has now started the FDA review in the United States of Essure and the process that Bayer stated showed the  device was tested and determined safe.

One woman in Great Britian – who later had her uterus removed – said she was left suicidal due to the “unbearable” pain, and felt she was a burden to her family.

The manufacturer Bayer says Essure is safe and the benefits outweigh the risks, which has been met with speculation as the sale of the implants in the EU was temporarily suspended this month and Bayer has asked hospitals in the UK not to use the device during this time.

“Too painful to move”

Laura Linkson, was alo fitted with the Essure device in 2013, and said the pain left her suicidal.

“The device was sold to me as a simple and easy procedure. I was told that I’d be in and out of the doctor’s office in 10 minutes and that there’d be no recovery time.

“I went from being a mum who was doing everything with her children, to a mum that was stuck in bed unable to move without pain, at some points being suicidal.

The small coil implants, which are made of nickel and polyester (PET) fibres, are used as a sterilization device to stop eggs reaching the womb.

They are inserted into the fallopian tubes where they trigger inflazmation, causing scar tissue to build up and eventually block the tubes, known as a hysteroscopic sterilization.

They can cause intense pain, and some women are thought to react badly to the nickel and plastic.

Because of the way the coils attach to the fallopian tubes, the only way to take them out is to remove a woman’s fallopian tubes and often her uterus.

In other cases the device has been found to perforate fallopian tubes and fallen out, embedding itself elsewhere in the body.

Victoria Dethier was implanted with Essure in 2012 and for three years could not work out why she felt so unwell. “There were moments where I couldn’t get out of bed I was in so much pain. It felt like I was dying, like something was killing me from the inside,” she said.

She thinks her body was reacting to the PET fibres designed to cause inflammation.

She had a hysterectomy to remove the device in 2015.  “Straight away there was a difference, I’d experienced a horrible taste in my mouth and that had gone,” she explained.as well as  I’d lost a lot of hair and that came back within 12 months, it was incredible.”

“We need acknowledgement by Bayer”

The medicines and healthcare products regulatory agency (MHRA – UK) has been criticized for not responding to the increasing evidence regarding the device.

In 2015, a study published in the British Medical Journal (BMJ) suggested that women who had a hysteroscopic sterilization were 10 times more likely to need follow-up surgery than those who had a traditional sterilization – 2.4% of those surveyed, as opposed to 0.2% amongst those having a standard sterilization.

In the US more than 15,000 women have reported problems to the US Food and Drug Administration (FDA), including pain, allergic reactions and “migration of device” that are involved in thousands of lawsuits versus Bayer Corporation and it’s German parent Bayer, AG.

Carl Heneghan, from the Centre for Evidence-Based Medicine at Oxford University, has criticized the regulator’s failure to act on such findings.  “How much evidence do you need to say let’s withdraw this product from the market?” he asked.

Victoria Dethier is angry that she and so many other women feel they have been ignored “No-one is listening to us, and now there are many women coming forward… we need to be acknowledged.”

Bayer Says “No long-term evidence of adverse events”

The full extent of the problem in the UK is not known.

The MHRA rejected the Victoria Derbyshire program’s Freedom of Information request asking how many women have reported problems.

The NHS does not have figures for the total number of women who have been fitted with Essure, or who have had it removed.

However, the clinical trial that led to the device being approved has been criticized for not considering the long-term effects of the implants, which Bayer has defended to this day. “The trial… only followed up women for one year, so nobody has a real understanding of what happens with this device after two years, three years, five years,” Mr Heneghan explained, and based on worldwide reporting of thousands of “adverse Events” it now seems that Bayer will have to begin the process of accepting responsibility for the Essure device medical problems claimed by the thousands of women who had the device implanted.

Some women who have experienced problems say they were not informed about the risks.

But Ben Peyton-Jones, a British consultant-obstetrician and gynecologist, said the device should still be used in some instances. Starting “I think it has a place for women who can’t have keyhole surgery and who are explained the risks very carefully,” when asked about the continued viability of Essure.

“When used correctly, according to the manufacturer’s guidance and in trained hands, it is safe.”

European Union Essure Use Suspended

The sale of Essure implants in the EU has now been suspended for further investigation and hospitals have been asked by Bayer not to use their existing stocks during this time.  This is a voluntary request and up to individual trusts to decide what to do.

The company said that independent reviews of Essure had concluded that the benefits outweighed the risks.

“Patient safety and appropriate use of Essure are the greatest priorities for Bayer, and the company fully stands behind Essure as an appropriate choice for women who desire permanent contraception,” it added in a statement. Bayer will immediately start damage control in the USA as soon as the UK-EU restrictions on Essure become known, specifically in the massive Essure Multidistrict Litigation, wher thousands of women in the United States are alleging major complications and onset of medical disability due to the Essure “adverse events” even while Bayer insisted the product was safe.

“Many women with Essure rely on this form of contraception without any side effects.”

The MHRA said it had no evidence to suggest this product was unsafe, and that the recent suspension did not suggest any increased risk to patient safety.

It said it was important for healthcare professionals to discuss the risks with patients before a procedure.

 

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Johnson & Johnson and DePuy Pinnacle Hip Implant Trial Continued Until September 18th Based on Appeal

Johnson & Johnson and DePuy Orthopaedics Latest “Pinnacle Hip Implant Trial” Continued Until September 18th Based on Fifth Circuit Appeal 

  • By Mark A. York (September 15, 2017)

  • Mass Tort Nexus

 

 

 

 

 

The latest bellwether trial in the  DePuy Pinnacle MDL 2244 (see DePuy Pinnacle Hip Implant MDL 2244 Briefcase) litigation has been postponed until September 18th, based on the U.S. Court of Appeals for the Fifth Circuit ruling, just days before the trial was to start, where they cited “grave error” by the sitting US District Court judge, in requesting a trial delay. The trial start date was September 5th, where eight plaintiffs from New York were part of the DePuy Pinnacle MDL 2255 multidistrict litigation, who are now facing jurisdictional issues based on the June 2017 SCOTUS “Plavix Ruling” that restricts jurisdiction over plaintiffs who are residents of another state, SCOTUS Plavix Jurisdictional Ruling Strikes Non-Resident CA Plaintiffs. The Plavix ruling forced thousands of non-California residents to determine if and where they can refile their claims against Bristol-Myers Squibb. DePuy Orthopaedics and it’s parent Johnson & Johnson (J&J) are asserting the Plavix ruling by stating that the New York residents are not subject to jurisdiction of the US District Court ND Texas and the trial should be stopped. This seems to fly in the face of the justification of certain tenants of the Joint Panel on Multidistrict Litigation rules of procedure, which assigned the DePuy Pinnacle Hip Implant cases to the Texas court to consolidate the many thousands of cases across the country.

 J&J Wants To Avoid More Massive Trial Verdicts

J&J are simply using evry legal tool available, in an attempt to avoid another massive jury verdict like the one in the December 2016 Pinnacle Hip Implant trial, where California plaintiffs were awarded $1 billion in punitive damages, which the court subsequently reduced to $500 million on appeal. DePuy and J&J want to restrict plaintiffs in any way they can, as J&J is facing massive verdicts in other ongoing federal and state court cases related to it’s various other medical device and pharmaceutical product lines.

Appeals Panel Denies Writ of Mandamus Petition

On August 23rd, the Fifth Circuit panel denied Johnson & Johnson’s and DePuy Orthopaedics’ petition for writ of mandamus, which sought to halt the upcoming trial. However, two of the three panel members found that the judge proceeding over the consolidated DePuy Pinnacle litigation in Texas had allowed certain trials to take place before him which a “judicial error” including the one that as scheduled to begin yesterday where plaintiffs were New York residents. On September 1st, U.S. District Court Judge Ed Kinkeade of the Northern District of Texas issued an Order delaying the next DePuy Pinnacle hip replacement trial until September 18, 2017.

DePuy Pinnacle Hip Verdicts

The multidistrict litigation underway in the Northern District of Texas, DePuy Pinnacle MDL 2244, currently involves more than 9,000 hip replacement lawsuits related to the metal-on-metal version of DePuy Orthopedics’ Pinnacle hip system that utilizes the Ultamet liner. Plaintiffs claim that this configuration is defectively designed, as it sheds toxic metals into the joint surround the hip, as well as the blood stream, causing adverse local tissue reactions, metallosis, pseudotumor formation, and other complications that necessitate the need for revision surgery to replace the joint.

As of August 2017, MDL 2244 Pinnacle hip litigation has convened three bellwether trials. The first concluded in October 2014, with a verdict for DePuy and Johnson & Johnson.

In March 2016, five plaintiffs were awarded a total of $500 million at the close of the second DePuy Pinnacle trial, where the judge overseeing the case reduced the award to $151 million, in order to comply with Texas law governing punitive damages.

The largest hip implant trial verdict anywhere to date was in the DePuy MDL’s third bellwether trial which ended December 2, 2016, where six Pinnacle implant recipients, who were California residents, were awarded more than $1 billion in punitive damages, see $1 billion DePuy Hip Implant Verdict in MDL 2244, with the judgment later reduced to $543 million, by Judge Kinkeade.

DePuy Metal-on-Metal Hip Implant Issues

In January 2013, the U.S. Food & Drug Administration warned that metal-on-metal hip replacements were associated with higher rates of early failure compared to those constructed from other materials.  Last year, the FDA finalized a new regulation requiring the manufacturers of two types of metal-on-metal hips to submit a premarket approval (PMA) application if they wanted to continue marketing their current devices and/or market a new implant.

In August 2010, DePuy Orthopaedics announced a recall of its ASR metal-on-metal hip replacement system, after data indicated the hips were associated with a higher-than-expected rate of premature failure.  Plaintiffs who have filed Pinnacle hip lawsuits question why the company has not taken similar action in regards to the Pinnacle/Ultamet liner combination.

In May 2013, DePuy Orthopaedics did announce that it would phase out metal-on-metal hip implants, including the device named in Pinnacle hip replacement lawsuits. According to The New York Times, the company cited slowing sales, as well as the FDA’s changing regulatory stance on all-metal hip implants, as factors in its decision.

 

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Boston Scientific Pelvic Mesh Cases Removed From Philadelphia Court of Common Pleas Based on SCOTUS “Plavix” Ruling

Boston Scientific Mass Tort Mesh Cases Removed From Philadelphia Court of Common Pleas Based On Recent Supreme Court  June 2017, Bristol Myers vs. California Superior Court “Plavix” Ruling

 

 

 

 

 

 

Boston Scientific, Marlborough, MA

By Mark A. York (September 7, 2017)

Plaintiffs who filed suit against Boston Scientific in a Philadelphia court over allegedly defective pelvic mesh, have agreed to have their cases removed from the Pennsylvania Court to other venues based on the June 2017 “Bristol-Myers California Plavix” U.S. Supreme Court opinion.  The Plavix ruling has thrown thousands of non-resident drug and medical device state court cases across the country into turmoil, as the non-resident plaintiffs cannot continue their cases in state courts where they do not reside or the defendant companies are not corporate residents.  This was based on the Supreme Court ruling that stated Bristol-Myers R&D and sales activity in the State of California related to it’s Plavix blood thinner, (see Mass Tort Nexus “Plavix” CA State Court Briefcase) was not enough of a corporate presence to subject them to California state court jurisdiction, resulting in jurisdictional issue across the country for plaintiff firms.

Last month, Boston Scientific filed motions asking the court to remove any cases pending against it in the Philadelphia Court of Common Pleas, citing the Supreme Court’s both the “Bristol-Myers Squibb v. Superior Court of California”, see US Supreme Court Strikes Down State Court Jurisdiction and “BNSF Railway v. Tyrrell”, see SCOTUS Limits What State Court A Corporate Defendant Can Be Sued In.

According to one of the lead attorneys, the parties have agreed to litigate the cases in either Massachusetts, where Boston Scientific has its principal place of business, or in Delaware, it’s state of incorporation.

Kline & Specter attorney Shanin Specter said. “An agreement was reached with Boston Scientific to have the cases heard in a courtroom other than the Philadelphia Court of Common Pleas, so the cases can move forward and litigate without the jurisdictional issue creating legal issues. Although Boston Scientific’s motion last month sought to remove 94 cases, Specter said only three cases had been moving forward against Boston Scientific with calls placed to Boston Scientific defense counsel Shook, Hardy & Bacon and attorney Joseph Blum seeking comment have not been returned.

Judge New Asked to Reconsider

Last month, Boston Scientific had filed a motion requesting Philadelphia Court of Common Pleas Judge Arnold New reconsider his March 2015 decision that the state court had jurisdiction over the mesh cases.  New, who is the supervising judge of Philadelphia’s Complex Litigation Center, issued a one-page order saying Boston Scientific’s motion was moot.

As part of the motion, Boston Scientific had sought to have New’s 2015 ruling vacated to allow for additional arguments on the issue, and allowing defense counsel to begin pleading the removal of thousands of other non-resident plaintiff cases currently in in the court’s complex litigation docket.

Ethicon Mesh Motion for Removal

Another major defendant in over one thousand pelvic mesh mass cases , Johnson & Johnson subsidiary Ethicon, has also filed motions recently seeking to have the cases dismissed based the Supreme Court’s recent decisions. Plaintiffs, however, have requested Judge New pend any rulings on these issues, based on the Pennsylvania Superior Court has agreed to consider the matter in a case that is pending before the intermediate court on appeal.

The Supreme Court’s ruling from June 19, 2017 in Bristol-Myers vs. Superior Court of California (see US Supreme Court Denies California State Court Jurisdiction) now seen as the defining game-changing decision, for mass torts in state courts, that has promised to reshape the geography of mass tort litigation across the country. In the ruling, a majority of the Supreme Court determined that plaintiffs suing Bristol-Myers Squibb in California who were not California residents had failed to establish specific jurisdiction over the pharmaceutical giant, since there was no significant link between the claims and Bristol-Myers’ conduct in California. The ruling, according to observers, makes clear that out-of-state plaintiffs can’t sue companies in states where the defendants aren’t considered to be “at home,” or haven’t conducted business directly linked to the claimed injury.

Johnson & Johnson Files For Missouri Removals

Earlier this month, J&J filed a motion in Missouri seeking to dismiss more than 1,300 lawsuits against it over talcum powder, claiming the lawyers had engaged in “blatant forum shopping on a grand scale.” On June 19, 2017 St Louis City Court Judge Rex Burlison declared a mistrial in the fifth talcum powder cancer trial being heard there, which was the afternoon of the SCOTUS “Plavix” ruling, declaring that the opinion earlier that day prevented the trial from moving forward. The trial was reset for October 2017, and the parties are currently arguing the jurisdictional issues of resuming the trial in front of Judge Burlison, see Mistrial Declared in J&J Talc Trial Due to SCOTUS Ruling.

Boston Scientific Argument

In requesting reconsideration regarding the recent Supreme Court decisions, Boston Scientific contends that Pennsylvania state courts no longer have jurisdiction over it. Specifically, the motion said Boston Scientific is a Delaware corporation with its principal place of business in Massachusetts, it does not have sufficient ties to Pennsylvania to render it “at home” in the state, and the plaintiffs are not Pennsylvania residents. The company further says that finding Pennsylvania has jurisdiction simply because the company complies with the state’s business registration statute violates the due process clause of the U.S. Constitution and the now precedent “California Plavix” decision, .

“It is undisputed that Boston Scientific’s principal place of business is Massachusetts while its place of incorporation is Delaware,” the motion said. “Those are the only two jurisdictions where Boston Scientific is so heavily engaged in activity as to render it ‘at home.”

State Court Removal and Refiling Across The Country

The Philadelphia Court of Common Please Complex Litigation Docket appears to be preparing for a departure of many of the thousands of product liability cases, which prior to June 19, 2017 were moving along quite well in the under the direction of Judge Arnold New. State court dockets across the country are now forced to consider the removal of many cases as well as the potential refiling of thousands of cases in the state of incorporation for the medical device and pharmaceutical manufacturers.

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DePuy Pinnacle Hip Implant Trial Set for Today Delayed Based on Appellate Ruling of “Grave Error” By Sitting Judge

DePuy Pinnacle Hip Implant Bellwether Trial Set For September 5th Delayed After Appeals Court Cites Grave Error By Judge

 

 

 

 

 

DePuy Orthopaedics, Inc a subsidiary of Johnson & Johnson

By Mark A. York (September 5, 2017)

Federal Judge Ed Kinkeade has delayed the next DePuy Pinnacle hip implant bellwether trial that was set for today, Sept. 5, 2017 until later this month after a split federal appeals panel requested that he halt the proceedings due to a “grave error.”

In the August 31st opinion, two of three judges on a panel of the U.S. Court of Appeals for the Fifth Circuit refused to grant a petition for writ of mandamus filed by DePuy Orthopaedics Inc. to halt the trial. But two of the three also concluded that U.S. District Judge Ed Kinkeade, who is presiding over 9,300 cases alleging DePuy’s Pinnacle hip implants are defective, committed a “grave error” in allowing certain trials to take place before him, including the one scheduled this month on behalf of eight New York plaintiffs.

Opinion Outline

The opinion stated “despite finding serious error, a majority of this panel denies the writ that petitioners seek to prohibit the district court from proceeding to trial on plaintiffs’ cases,” wrote Circuit Judge Jerry Smith. “A majority requests the district court to vacate its ruling on waiver and to withdraw its order for a trial beginning September 5, 2017.”

Skadden, Arps, Slate, Meagher & Flom lead counsel for Johnson & Johnson, DePuy’s parent company, called on Judge Kinkeade to halt the trial, which is the fourth bellwether in the multidistrict litigation over the DePuy Pinnacle hip implant. This may help DePuy and J&J avoid a repeat of the last Pinnacle verdict in the prior bellwether trial where a Dallas jury awarded over $1 billion in damages, subsequently reduced by Judge Kinkeade, see DePuy Pinnacle Hip Implant Dec 2016 Trial Verdict Halved to Just $500 million in December 2016, which DePuy-J&J are appealing.

“We are pleased that the Fifth Circuit has determined that the MDL court does not have jurisdiction to conduct its planned trial of the claims of eight New York plaintiffs in a Texas courtroom,” Beisner wrote in an emailed statement after the ruling.

Plaintiff Counsel Surprised

Lead plaintiffs attorney Mark Lanier called it the “wildest opinion I’ve ever seen.”

“What this small panel has tried to do is change the law in the Fifth Circuit on a mandamus record, and that’s really frowned about,” said Lanier, of The Lanier Law Firm in Houston, who was joined in the appeal by former U.S. Solicitor General Kenneth Starr.

In addition to this month’s trial, the ruling could impact a separate case before the Fifth Circuit in which Johnson & Johnson has raised the same venue arguments in appealing a $1.04 billion verdict in the most recent Pinnacle trial. Oral argument on that appeal hasn’t yet been scheduled.

“Why this court issues an order on another court’s case, which is just an advisory opinion, is just absurd,” said Lanier. “It’s judicial activism.”

Lanier filed a petition for rehearing en banc on Friday. Later that afternoon, Kinkeade ordered the trial delayed until Sept. 18.

Final Bellwether trial

Kinkeade appeared to anticipate the Fifth Circuit’s intervention. On Aug. 25, he ordered that this month’s trial would “be the final bellwether case tried in the Dallas division of the Northern District of Texas” under which both sides have waived venue.  This was an unexpected ruling for the Pinnacle litigation, where Johnson & Johnson has appealed two other verdicts in Kinkeade’s courtroom, both involving consolidated cases that led to major awards in 2016,. Johnson & Johnson won the first verdict in 2014. But a second trial ended with a verdict of $502 million awarded to five Texas plaintiffs, while the third gave $1.04 billion verdict to six California plaintiffs.

All DePuy Hip Implant Litigation

These cases are part of the 8,707 actions consolidated before Judge Kinkeade in MDL 2244, In re DePuy Orthopaedics, Inc., Pinnacle Hip Implant Products Liability Litigation, Case No. 3:11-md-02244, Northern District of Texas in Dallas.

Juries have found that DePuy and J&J have negligently designed the hip implant, failed to warn surgeons about dangerous conditions related to the implant, and concealed its risks. J&J stopped selling the devices in 2013 after the FDA issued a safety communication about artificial-hip damages.

Separately, DuPuy is facing 1,458 product liability actions consolidated before US District Judge Jeffrey J. Helmick in MDL 2197, In re: DePuy Orthopaedics, Inc., ASR Hip Implant Products Liability Litigation in Toledo, Ohio.

J&J prevailed in the first Pinnacle hip case to go to trial in October 2014 after a jury rejected a Montana woman’s claims that the devices were defective and gave her metal poisoning. In March 2016, a Dallas jury ordered J&J to pay $502 million to a group of five patients who accused the company of hiding defects in the hips. A judge cut that verdict in July to about $150 million.

DePuy Claims “Lexecon” Error

DePuy and Johnson & Johnson have argued that Kinkeade lacked jurisdiction over the trials involving California and New York plaintiffs. MDL judges are assigned to oversee pretrial matters with the intention of sending cases back to their original courts for trial. But defendants often waive that right under the U.S. Supreme Court’s 1998 holding in Lexecon v. Milberg Weiss Bershad Hynes & Lerach, which allows bellwether trials to proceed before an MDL judge.

Johnson & Johnson claims it waived that right as to the first and second trials, but not the third or fourth. Plaintiffs’ attorneys have insisted that Johnson & Johnson agreed to a global waiver over all the trials.

Mass Tort Nexus will provide additional details of the ongoing trial dispute as information becomes available.

 

 

 

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FDA Safety Notice Letter “Recommends The Continued Use Of Forced Air Thermal Regulation Systems During Surgery”

Does the August 30, 2017 FDA Medical Device Safety Notice Letter Impact the BAIR HUGGER MDL 2666 FORCED AIR WARMING DEVICES Litigation? 

3M™ Bair Hugger™ Blanket System

 

 

 

 

 

 

 

 

US Food & Drug Administration Healthcare Provider Notice, August 30, 2017

FDA Safety Information Notice: Forced Air Thermal Regulating Systems: Healthcare Provider Letter – Information About Use

08/30/2017 – Dear Health Care Provider Letter – FDA]

AUDIENCE: Surgery, Nursing, Anesthesia

ISSUE: The FDA is reminding health care providers that using thermoregulation devices during surgery, including forced air thermoregulating systems, have been demonstrated to result in less bleeding, faster recovery times, and decreased risk of infection for patients.

The FDA recently became aware that some health care providers and patients may be avoiding the use of forced air thermal regulating systems during surgical procedures due to concerns of a potential increased risk of surgical site infection (e.g., following joint replacement surgery). After a thorough review of available data, the FDA has been unable to identify a consistently reported association between the use of forced air thermal regulating systems and surgical site infection.

Therefore, the FDA continues to recommend the use of thermoregulating devices (including forced air thermal regulating systems) for surgical procedures when clinically warranted. Surgical procedures performed without the use of a thermoregulation system may cause adverse health consequences for patients during the postoperative and recovery process.

The FDA will continue to actively monitor this situation and will update this communication if significant new information becomes available.

BACKGROUND: Forced air thermal regulating systems, also called forced air warmers or forced air warming systems, are devices used to regulate a patient’s temperature during surgical procedures. Forced air thermal regulating systems use an electrical blower to circulate filtered, temperature controlled air through a hose into a blanket placed over or under a patient.

To determine if there is an increased risk of surgical site infection when forced air thermal regulating systems are used during surgery, the FDA collected and analyzed data available to date from several sources, including medical device reports received by the agency, information from manufacturers and hospitals, publicly available medical literature, operating room guidelines, and ventilation requirements.

RECOMMENDATION: FDA continues to recommend the use of thermoregulating devices (including forced air thermal regulating systems) for surgical procedures when clinically warranted. As always, please follow the manufacturer’s instructions for use in the operating room/and or the post-operative environment.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

 

FDA Medical Device Safety Notice

“Official Notice Letter”

 Information about the Use of Forced Air Thermal Regulating Systems – Letter to Health Care Providers

August 30, 2017

Dear Health Care Provider,

The FDA is reminding health care providers that using thermoregulation devices during surgery, including forced air thermoregulating systems, have been demonstrated to result in less bleeding, faster recovery times, and decreased risk of infection for patients.

The FDA recently became aware that some health care providers and patients may be avoiding the use of forced air thermal regulating systems during surgical procedures due to concerns of a potential increased risk of surgical site infection (e.g., following joint replacement surgery). After a thorough review of available data, the FDA has been unable to identify a consistently reported association between the use of forced air thermal regulating systems and surgical site infection.

Therefore, the FDA continues to recommend the use of thermoregulating devices (including forced air thermal regulating systems) for surgical procedures when clinically warranted. Surgical procedures performed without the use of a thermoregulation system may cause adverse health consequences for patients during the postoperative and recovery process.

Forced air thermal regulating systems, also called forced air warmers or forced air warming systems, are devices used to regulate a patient’s temperature during surgical procedures. Forced air thermal regulating systems use an electrical blower to circulate filtered, temperature controlled air through a hose into a blanket placed over or under a patient.

To determine if there is an increased risk of surgical site infection when forced air thermal regulating systems are used during surgery, the FDA collected and analyzed data available to date from several sources, including medical device reports received by the agency, information from manufacturers and hospitals, publicly available medical literature, operating room guidelines, and ventilation requirements

As always, please follow the manufacturer’s instructions for use in the operating room/and or the post-operative environment.

FDA ACTIONS

The FDA will continue to actively monitor this situation and will update this communication if significant new information becomes available.

CONTACT US

If you have questions about this communication, please contact CDRH’s Division of Industry Communication and Education (DICE) at DICE@FDA.HHS.GOV, 800-638-2041, or 301-796-7100.

Sincerely,
/s/
William Maisel, MD, MPH
Deputy Center Director for Science
Center for Devices and Radiological Health
U.S. Food and Drug Administration

 

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Does Using Talcum Powder Cause Ovarian Cancer?

Does Johnson & Johnson talcum powder cause ovarian cancer?

(Mass Tort Nexus, August 28, 2017)  Johnson & Johnson has been ordered to pay nearly $1 billion in total damages after just 5 trials, alleging its baby powder is causing ovarian cancer, all jury verdicts have been in state courts in Missouri and California, see J&J Talc Trials St. Louis Missouri.

 

 

 

 

 

 

A Los Angeles jury said yes, and last week it ordered Johnson & Johnson (J&J) to pay $417 million to 63-year-old Eva Echeverria, She blamed her terminal illness on Johnson’s Baby Powder, which she used for decades starting at age 11. Her argument was, the company should have warned consumers about the risk, which J&J stated was not necessary and the jury chose to believe Ms. Echeverria and her trial team.

The jury award is the biggest yet against J&J, which has lost 5 of 6 trials involving claims that its baby powder and Shower to Shower powder cause ovarian cancer. The company denies there’s a connection between its products and the disease and quickly said it would appeal the Los Angeles verdict. Lawsuits involving thousands more plaintiffs are pending, see Johnson & Johnson Talc MDL 2738 Briefcase.

Medical industry and cancer research experts divide sharply on talc’s role. Some are convinced the powder is linked to an increased risk of ovarian cancer, while other  including government health experts, say the evidence is lacking.

Amanda Fader, a gynecologic oncologist at Johns Hopkins University who was not involved in the studies states “The scientific body of literature is not compelling at this time to support a strong association between talcum powder and ovarian cancer, let alone to say that any one specific case was associated with powder,” and The American Cancer Society says that studies on talcum powder and ovarian cancer “have been mixed, with some studies reporting a slightly increased risk and some reporting no increase.

Yet Fader and others aren’t ruling out that a link might someday be established. The Food and Drug Administration, which says it has found no link, is doing additional research on the topic. Although, J&J has spent millions of dollars lobbying and influencing all areas of FDA and related public oversight and commentary to prevent and type of link between cancer and talcum powder products from being abbounced, even while competitor talc products sold at Wal-Mart and Dollar Tree post warning labels declaring a possible link.

Talc, a mineral composed of magnesium, silicon, oxygen and hydrogen, is used extensively in cosmetics and personal care products. Women sometimes use talcum powder on their genital areas, sanitary napkins or diaphragms to absorb moisture and odor – contrary to the guidance of most physicians. (Asbestos, linked to lung cancer, was once an impurity in talc, but it has been banned for several decades.)  J&J is notorious for using any means possible to influence scientific data and opinion as well as manipulating research reports and public media commentary by industry experts. The recent California trial showed payments made to previously perceived impartial Science Council members, who were declaring publicly that J&J talcum powder does not pose a cancer risk, the Los Angeles jury did not agree with J&J and other pro-talc defense team members, as over $300 million of the total $417 million judgment was for punitive damages, usually awarded for intentional misconduct, see“New Evidence of Johnson & Johnson Bad Conduct Moved LA Jury to Award $417 Million Talc Verdict”.

Many pediatricians also discourage the use of such powder on babies because the particles can cause breathing problems, according to Jennifer Lowry, a pediatrician and environmental health expert at Children’s Mercy Hospital in Kansas City.

More than 22,000 women in the United States will be diagnosed with ovarian cancer this year, and 14,000 will die. The biggest risk factors, all well established, include a family history of breast or ovarian cancer, mutations in the BRCA genes and age.

The debate over talc began decades ago. In the early 1970s, scientists discovered talc particles in ovarian tumors. In 1982, Harvard researcher Daniel Cramer reported a link between talcum powder and ovarian cancer. His study was followed by several more finding an increased risk of ovarian cancer among regular users of talcum powder. Cramer, who at one point advised J&J to put a warning on its products, has become a frequent expert witness for women suing the company. J&J ignored and suppressed Mr. Cramer’s attempts to show them the study data then publicly declared this research as flawed, which J&J still continues to this day.

His studies and the many others that have found a relationship used a case-control approach. A group of women diagnosed with ovarian cancer and a group without it were asked to recall their past diet and activities, and the results were then compared.

Critics say these kinds of studies have serious drawbacks, particularly “recall bias.” Women may forget what they did or, if diagnosed with cancer, might inadvertently overestimate their use of a suspect substance. People without a serious disease may be less motivated to remember details.

Three other studies – considered cohort studies – did not find any overall link. Unlike the case-control studies, these efforts began with a large group of women who did not have cancer and followed the progress of their health, with participants recording what they were doing in real time. The results of this approach, most scientists say, are stronger because they aren’t subject to the vagaries of memory.

One such study included more than 61,000 women followed for 12 years as part of the National Institutes of Health’s well-respectedWomen’s Health Initiative.

But critics, including Cramer, say these investigations have their own flaws. Because ovarian cancer is so rare, they say, prospective studies don’t always end up with enough cancer cases to detect a potential link between talcum powder and the disease.

And evidence can change as new research becomes available. That explains why the NCI, which uses expert “editorial boards” to vet the voluminous information it puts out for doctors and consumers, has amended its language on talc.

In February 2014, one editorial board reviewed an analysis of several case-control studies that found genital-powder use was associated with a “modest increased risk” of ovarian cancer. The board decided to add the article to the NCI website and noted a weak association between talc and ovarian cancer. It also added a link to the website of the International Agency for Research on Cancer, a World Health Organization agency that had concluded years ago that talcum powder was “possibly carcinogenic,” when used in the genital area.

But a year later, the same board scrutinized the Women’s Health Initiative study and took another look at previous studies. That’s when it changed the wording on the NCI’s site to say the “weight of evidence” did not support a link. The board also removed the IARC information. This all occurred after Johnson & Johnson used lobbying pressure and alleged payments to various affiliated entities to influence the NCI change of formal opinion

The FDA has wrestled with the issue, too. In 2014, it denied a citizens’ petition asking the agency to require a warning label on talcum powder; its review of the scientific literature found no link between the product and cancer, officials said.

But because the agency continues to get “adverse event reports” involving talcum powder, it is taking another look at the evidence and launching its own laboratory research. The summary for one study, funded by the FDA’s Office of Women’s Health, says that “talc’s effects on female genital system tissues have not been adequately investigated.”

In a statement after the Los Angeles verdict, J&J said that “we deeply sympathize with the women and families impacted by this disease.” But, it added, the science “supports the safety of Johnson’s Baby Powder.”

No matter what side they are on, scientists agree that more research – through lab studies with animals or human tissue – is needed to understand how talcum powder could potentially cause cancer. One hypothesis is that talc applied to the genital area can migrate up the vagina to the ovaries, causing chronic inflammation that eventually results in malignancies. But that is only a hypothesis.

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“New Evidence of Johnson & Johnson Bad Conduct Moved LA Jury to Award $417 Million Talc Verdict”

Johnson & Johnson Still Influencing Opinion by Paying Cash to Insiders in Talc Cancer Fight

New Evidence of J&J Bad Conduct Moved LA Jury to Award $417 Million Talc Verdict”

 

 

 

 

 

 

 

 

Why did California jurors enter a verdict in favor of a cancer stricken plaintiff last week for $417 million in the latest trial over Johnson & Johnson’s (J&J) talcum powder and links to ovarian cancer?(see J&J Loses Another Talc Cancer Trial) It seems as if the largest talc cancer trial verdict to date, may have been influenced by new evidence, including an emailed photo that arrived at the start of trial, apparent payments to science industry insiders and a key J&J witness who was sanctioned and discredited for false testimony at a trial in North Carolina, according to one of plaintiffs’ counsel in the case.

The jury, in front of Judge Maren Nelson, Los Angeles Superior Court, (Eva Echeverria vs. Johnson & Johnson, Case No. BC628228), awarded Ms. Echeverria $70 million in non-economic damages and $347 million in punitive damages after finding that Johnson & Johnson failed to warn that its baby powder could cause ovarian cancer. Eva Echeverria was diagnosed with ovarian cancer in 2007, and was unable to testify at trial due to her illness.

Thousands of women have brought lawsuits making similar claims, most of which are in California, Missouri and New Jersey. Plaintiffs’ attorney Allen Smith, of The Smith Law Firm, who has tried all six of the previous trials, five of which were in Missouri. A seventh Missouri trial never went to a jury after the judge granted a mistrial, (see J&J Talc Trial Mistrial Declared After SCOTUS Ruling,)  on the day of the California-Plavix state court jurisdictional opinion. The juries hearing cases linking talcum powder to cancer have awarded four prior plaintiffs’ verdicts, totaling over $300 million, with the highest previous verdict being $110 million and all were awarded in Missouri state courts.

Introduction Of Damaging Evidence Against J&J:

Competitor Warning Labels

The California jury award was tied to three new pieces of evidence that other jurors hadn’t heard before, including evidence that baby powder products made by other companies sold at Walmart and Dollar Tree had warnings on the bottles showing the risks of ovarian cancer. Plaintiffs’ lawyers found out about the labels after a client of Ted Meadows, a partner at Beasley, Allen, et al, in Montgomery, AL, one of the trial attorneys, emailed a photo of a product with a warning label to them just before the Los Angeles trial began. “That was very welcome news to us,” Meadows said. “And the way it played out during the trial, I think it was news to J&J.”

Payments To Industry Insiders

Introduction of evidence that two individuals involved in the Cosmetic Industry Review (CIR), which has deemed talcum powder to be safe, which is data J&J has relied on in prior trials, had received payments from Johnson & Johnson for speeches and other engagements. This damaging information was discovered while cross-examining the group’s former director, Alan Andersen, who was a defense witness, and he was forced to disclose the prior unknown financial relationship of the CIR and Johnson & Johnson.

Bad Science

A major blow to J&J’s defense came when a defense witness, Senior Johnson & Johnson epidemiologist, Dr. Douglas Weed, was revealed to have been sanctioned for perjury in another trial in North Carolina, for lying under oath about whether he retained notes to his expert report, which plaintiffs attorneys were able to show.

“J&J presented these unbelievable and non-credible witnesses on an issue that is very important to our case,” Smith said. “Attempts to influence witnesses and alter facts, along with the fact other companies are warning of the cancer link and have been warning for eight to 12 months now. This was new evidence that proved very compelling to the jury as well as a reflection of J&J’s willingness to manipulate the trial process in their favor”, leading many to wonder what else J&J may have done.

In a post trial statement J&J declined to address the specifics of the case, stating: “We will appeal today’s verdict because we are guided by the science, which supports the safety of Johnson’s baby powder. In April, the National Cancer Institute’s Physician Data Query Editorial Board wrote, ‘The weight of evidence does not support an association between perineal talc exposure and an increased risk of ovarian cancer.’ We are preparing for additional trials in the U.S. and we will continue to defend the safety of Johnson’s baby powder.”

In response, the Plaintiff team stated “The new evidence that came into the California case could play a role in the next talcum powder trial, which is set for Oct. 16 in Missouri, we certainly think it is evidence that should be presented, and we’ll make every attempt to do so,” Ted Meadows said.

Johnson & Johnson Has Thousands More Talc Trials Waiting

J&J faces thousands more federal lawsuits in the recently consolidated MDL 2738, In Re: Johnson & Johnson Talcum Powder Products Liability Litigation supervised by US District Judge Freda L. Wolfson in the US District Court of New Jersey, in addition, there are the ever growing number of state court cases pending in Pennsylvania, New Jersey and Delaware as well as the remaining thousands of cases in the California State Court consolidation, which are captioned Johnson & Johnson Talcum Powder, Case No. JCCP4872.

Evidence of Johnson & Johnson and misconduct both inside and outside the courtroom can do nothing to further prove their continued claims of “no connection between ovarian cancer and use of J&J talcum powder products”, except provide juries with information which will continue to cause massive plaintiff verdicts to be entered across the country as more damaging evidence against J&J comes to light and is introduced at trials.

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J&J Talcum Powder Cancer Trial Update: California State Court Jury Hears from Plaintiff Eva Echeverria’s Epidemiology Expert

“Plaintiff Eva Evecherria’s Case Selected For First Trial Due to Onset of End Stage Terminal Ovarian Cancer”

Is Johnson & Johnson Baby Powder Dangerous?

Plaintiff Eva Echeverria, whose case was selected for California’s bellwether trial, due to her declining health caused by ovarian cancer, continued to present evidence last week in Los Angeles Superior Court. (see Eva Echeverria vs J&J Talc Trial CA State Court ), and there are additional cases against J&J in Johnson & Johnson Talcum Powder Cases, No. JCCP4872.

On Friday, jurors heard from a Canadian epidemiology expert who was called to offer his opinions on studies linking talc-based powders to ovarian cancer.

Among other things, Jack Siemiatycki, an epidemiologist with the University of Montreal and McGill University, discussed his contributions to the International Agency for Research on Cancer’s 2006 monograph that deemed talc a possible human carcinogen. According to Law360.com, he also testified that his stance has changed since then, as he now thinks that it is more likely than not that talc can cause ovarian cancer.

Under cross examination, Siemiatycki acknowledged that he had not reviewed the plaintiff’s specific case, as his testimony was only intended to address the general link between use of talcum powder and ovarian cancer .

Johnson & Johnson Concerns Are Corporate Image Over Human Life

The talcum powder lawsuit selected for the California trial was filed on behalf of Ms. Echeverria, a 63-year-old woman who allegedly made Johnson & Johnson’s talc-based powders a regular part of her daily feminine hygiene routine in the decades prior to her ovarian cancer diagnosis. Like other plaintiffs around the country, she claims that tiny particles of talc entered her vagina and migrated to her ovaries, resulting in the type of inflammation that encourages the growth of ovarian cancer cells.

During opening statements earlier in the week, Escheverria’s attorney asserted that Johnson & Johnson had known of the alleged link between talc and ovarian cancer for decades, but decided to withhold warnings from the public to protect its image.

“It’s the safe and gentle corporate image of a mother and baby that the defendants are placing over human life, in this case,” he told the jury.

Delaware State Court Plaintiffs Request Coordination

10 plaintiffs who filed talcum powder lawsuits in Delaware Superior Court are seeing coordination of all ovarian cancer cases involving Johnson & Johnson products. In addition to Johnson & Johnson, Imerys Talc America Inc., and the Personal Care Products Council are named as defendants.

Talcum Powder Ovarian Cancer Cases Filed in Canada

In May 2016, a class action lawsuit was filed in Toronto, Ontario on behalf of Canadian women who allegedly developed ovarian cancer due to their long-term use of Johnson & Johnson’s baby powder for feminine hygiene. Plaintiffs assert that the company should have warned consumers decades ago about the alleged link between talc powder and ovarian cancer, and that doing so would have easily prevented many, many cases of the disease.

Missouri Talcum Powder Plaintiff Verdicts

Johnson & Johnson has been named a defendant in more than 3,000 talcum powder claims in state and federal courts throughout the country. In addition to California, similar litigation is currently underway in Missouri, New Jersey and Delaware state courts, as well as New Jersey Federal Court.

The Missouri litigation, has already resulted in 6 talcum powder trials, with plaintiffs winning 4, one defense verdict and the most recent June 2017 trial declared a mistrial due to a US Supreme Court ruling. The first concluded in February 2016, when the family of an Alabama woman who died of the disease was awarded $72 million ($10 million compensatory and $62 million punitive).

Three months later, Johnson & Johnson was ordered to pay $55 million ($5 million compensatory, $50 million punitive) to a South Dakota ovarian cancer victim.

The following October, another Missouri jury awarded $70 million, including $2.5 million in compensatory damages and $67.5 million in punitive damages, to a third plaintiff.

Missouri’s fourth talcum powder trial concluded in March 2017, with a win for Johnson & Johnson. In May, however, the company was hit with its largest talcum powder verdict thus far, when another Missouri jury awarded more than $100 million in compensatory and punitive damages to the plaintiff in the state’s fifth trial. The final trial in June, where Shawn Blaes and other non-Missouri plaintiffs were in mid-trial when Judge Burlison declared a mistrial just hours after the US Supreme Court ruled on the state versus federal court jurisdictional issue in Bristol-Myers vs. California Supreme Court.

How will the Bristol-Myers “California-Plavix” Ruling Affect Missouri and Other State Court J&J Talcum Powder Cases?

On June 19, 2017 in the most recent St. Louis courtroom trial, Estate of Shawn Blaes, et al vs. Johnson & Johnson Case No. 1422-CC09326-01, over Johnson & Johnson’s talcum powder, trial counsel received notice of a US Supreme Court decision that day and were changing trial strategy instantly, and scrambling to determine if the Supreme Court decision handed down that morning doomed their case. The ruling was from a California multi-plaintiff drug case, Bristol Myers-Plavix Litigation JCCP Case No. 4748 (San Francisco County Superior Court) where Bristol-Myers had appealed the August 29, 2016 California Supreme Court decision, where the California court ruled that “foreign resident plaintiffs were able to remain parties to the Plavix litigation in California State Court” see California Court Opinion Jurisdiction of Non-Resident Plavix Plaintiffs 8.29.2016. Bristol-Myers immediately appealed to the US Supreme Court, where appeal arguments were heard on April 24, 2017, see BMSQ California Plavix SCOTUS Appeal Transcript , which left non-resident plaintiffs in state court cases across the country in limbo, pending the ruling.  On June 19th the US Supreme Court in an 8-1 ruling clarified the non-resident question for many plaintiffs, including the three plaintiffs in the pending trial in front of Judge Rex Burlison, who immediately declared a mistrial. The Blaes trial has been reset for October 2017, pending motions and briefings regarding the Plavix ruling and how it applies to the trial.

There are already dismissals in federal and state court cases of non-resident plaintiffs in non-talc lawsuits, so what will the “California-Plavix” ruling do to the thousands of other talc cases pending across the country? That question remains to be answered.

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Endo International Agrees To An Additional $775 Million to Settle Remaining Mesh Lawsuits For A Total of $2.6 Billion

 

Endo International Plc has agreed as of August 7, 2017 to set aside an additional $775 million to resolve the remaining lawsuits alleging the company’s vaginal-mesh implants eroded in some women, leaving them incontinent and in pain related to the Transvaginal Mesh Multidistrict Litigation pending in the US District Court of West Virginia, see the Mass Tort Nexus briefcase, American Medical Systems MDL 2325 TVM Litigation Link, a subsidiary of Endo sold to Boston Scientific in 2015.

The agreement to fund settlement of the remaining 22,000 mesh suits means the company has now set aside more than $2.6 billion to finalize the litigation claims related to the American Medical Systems flawed medical devices, according to document filed with the U.S. Securities and Exchange Commission.

This comes a year after Dublin-based Endo shut down one of its units that makes mesh implants, used to support internal organs or treat incontinence, after being hit with many thousands of complaints over the devices.

“We believe it is a very important milestone for Endo to have reached agreements to resolve virtually all known U.S. mesh product liability claims,” Paul Campanelli, Endo’s president and chief executive officer, said Monday in a statement.

Other mesh-insert makers, including Johnson & Johnson and Boston Scientific Corp., still face thousands of claims in the U.S. and worldwide from women who blame the devices for injuring them. More than 100,000 transvaginal mesh lawsuits have been filed, making it one of the largest mass torts in history. About 75% of mesh lawsuits are consolidated in West Virginia federal court through seven multi-district litigation (MDL) cases. The rest are contained in state courts, including those in Pennsylvania and West Virginia.

J&J, based in New Brunswick, New Jersey, said in SEC filings in February that it was defending 54,800 cases over its inserts while Marlborough, Massachusetts-based Boston Scientific said that same month it faced 43,000 mesh claims. Both companies have settled some mesh suits. The U.S. Food and Drug Administration increased regulatory restrictions on the mesh inserts after concluding in 2014 they were high-risk. The agency ordered Endo’s American Medical Systems unit, J&J and other mesh makers to study organ-damage rates linked to the devices. J&J dropped some of its mesh lines in 2012.

The consolidated AMS cases are In re American Medical Systems Inc. Pelvic Repair Systems Products Liability Litigation, 12-md-02325, U.S. District Court, Southern District of West Virginia (Charleston). Endo paid $150 million in legal settlements related to its vaginal mesh in the 4th quarter of 2016 and now more payments are on the way. The company recorded a $834 million pretax charge to increase the estimated product liability accrual. It had already set aside $1.4 billion to cover the legal costs at the end of the previous settlements.

In 2015 Endo sold the men’s health portion of its American Medical Systems device unit to Boston Scientific for $1.6 billion, and renamed the remaining portion Astora Women’s Health. Endo had acquired AMS for $2.9 billion in 2011, making the purchase a significant misjudgment of corporate strategy in what was even then a highly litigated medical device area, as TVM was widely known as a product that was prone to high numbers of adverse events and regulatory scrutiny.

Endo International/American Medical Systems Settlement History

Endo International plc (Endo) acquired device maker American Medical Systems Holdings, Inc. (AMS) in 2011. Endo has agreed to pay out roughly $2.6 billion to settle cases claiming injuries from its vaginal mesh devices, which include the Perigee, Apogee and Elevate implants. The company has previously ceased production of AMS transvaginal mesh.

The following settlements amounts were agreed to by Endo in attempts to resolve mesh implants made by AMS:

$775 million settlement to resolve 22,000 mesh lawsuits in August 2017. This settlement resolves the remaining lawsuits against AMS mesh implants.

Approximately 450 mesh lawsuits resolved through two separate settlements in April and May 2015.

$400+ million to settle more than 10,000 mesh lawsuits (~$48,000 per case) in October 2014. With the move, Endo said that it resolved “substantially all” the remaining lawsuits against its AMS unit. The $400 million was in addition to $1.2 billion already pledged by Endo to cover mesh litigation.

$830 million settlement to resolve around 20,000 mesh lawsuits (~40,000 per case) in May 2014. The settlement came a day after the FDA said transvaginal mesh should be reclassified as a high-risk medical device and subject to stronger regulatory scrutiny. “The settlements, once final, will resolve a substantial majority of the AMS vaginal mesh-related claims,” Endo said in a statement at the time.

$55 million paid in June 2013 to settle an undisclosed number of lawsuits, according to a filing with the U.S. Securities and Exchange Commission.

 

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HERNIA MESH AND THE FDA “ARE THEY DOING ENOUGH OR DOING JUST ENOUGH TO JUSTIFY THEIR ROLE?”

 A Guide to Who’s Who in Hernia Mesh and the Documented Problems With Mesh in the USA

Hernia Hernia Mesh ProductsMesh Litigation: Who is the FDA Protecting?

Hernia mesh lawsuits are being filed across the country in state and federal courts. While reviewing pelvic mesh and bladder sling adverse events from thousands of incidents where severe hernia mesh complications have resulted in injuries up to and including death. Patterns began to appear, linking specific injuries with certain hernia mesh products. The investigation uncovered design defects in a large number of hernia mesh products currently on the market.

Over the course of the investigation, and immense amount of information and scientific studies were FDA reports as well as published major medical reviews. A brief, general summary for each hernia mesh study is provided. Links to the full study are also provided for further research; however, due to copyright laws, often only the abstract of the study is available publicly.

Why Learning About Hernia Mesh is Important

The FDA continues to quickly approve untested hernia mesh products, which benefits the medical device manufacturers and hurts the general public. When a product is then shown to be defective, severely injuring thousands nationwide, the FDA is slow to take any action. The manufacturers of hernia mesh know of the life-threatening complications their products can cause, but they don’t warn the public or surgeons. Educate yourself on the dangers of hernia mesh and warn those you know.

There are over 100,000 hernia meshes implanted every year in the United States. Many of the most dangerous hernia meshes remain on the market and have not been recalled by the FDA. Bowel obstructions and severe infections are common complications related to hernia mesh.

What is the FDA’s Opinion on Hernia Mesh?

In April of 2016 the FDA put out an article on hernia surgical mesh implants. The following excerpt demonstrates just how out of touch the FDA is with how dangerous current hernia mesh products are.

“Many complications related to hernia repair with surgical mesh that have been reported to the FDA have been associated with recalled mesh products that are no longer on the market. Pain, infection, recurrence, adhesion, obstruction, and perforation are the most common complications associated with recalled mesh. In the FDA’s analysis of medical adverse event reports to the FDA, recalled mesh products were the main cause of bowel perforation and obstruction complications.”

Just one month later, the manufacturer of the Physiomesh, Ethicon a subsidiary of Johnson and Johnson, removed the hernia mesh due to high rates of complications. Currently, the FDA’s website still has no information on the Physiomesh recall. Ethicon continues to deny that the Physiomesh was subject to a hernia mesh recall, but does admit that they withdrew the product from the market. To date, there have been very few hernia mesh products actually recalled. The majority of complaints that were reviewed are products that have not yet been recalled, or have simply been “pulled from the market.”

Is the FDA Turning a Blind Eye to the Complications Caused by Defective Hernia Meshes?

It seems like an outrageous proposition, until you read some of the adverse event reports that physicians and medical device sales representatives have reported to the FDA. Repeatedly, the FDA has been alerted to various defects related to specific hernia meshes that are resulting in life-changing complications, yet no action has been taken. To highlight how absurd it is that the FDA hasn’t taken action on various hernia mesh products, the Hollis Law Firm created a Parietex ProGrip lawsuit page and a Parietex Composite lawsuit page. Both pages highlight FDA adverse event reports that should have made it obvious to the FDA why patients were experiencing specific complications with certain hernia mesh products. Shortly after the two pages went live, the FDA’s entire online adverse event database went down. We’re just getting started though. Now that the FDA’s online adverse event database is back up, we will be making similar updates to every hernia mesh subpage

Why Does Hernia Mesh Cause So Many Complications?

Polypropylene before implantation

What causes the complications can vary depending on the hernia mesh product. Many hernia mesh products contain a type of plastic known as polypropylene, the same material that is used to make many types of pelvic mesh and bladder slings. Polypropylene is also used to make a wide variety of non-medical devices, such as fishing line and soda bottles. Polypropylene is utilized to make so many commercial products for one main reason, it’s dirt cheap. Here is a Polypropylene Material Safety Data Sheet (MSDS) for a type of polypropylene used in many hernia mesh products. The MSDS notes “Prohibited Uses: Applications involving permanent implantation into the body.” However, the manufacturers of many hernia mesh products continue to use polypropylene and deny that polypropylene degrades and contracts.

Polypropylene 18 months after implantation

Should Hernia Mesh Ever Be Used?

Yes, there are times when mesh needs to be utilized to repair a hernia. The larger a hernia is, the more likely a mesh is needed. If a mesh is required to repair the hernia, there are more than 50 different hernia mesh products to choose from. Various manufacturers utilize a wide range of materials to make their hernia meshes. These materials range from plastics to gels to pig skins. Later in this article, we will cover some of the most dangerous types of hernia mesh. Additionally, certain hernias are easier to fix without using mesh. Inguinal hernias are typically smaller and can be repaired without mesh by a skilled surgeon. The unnecessary use of hernia mesh to repair inguinal hernias has resulted in thousands of patients developing debilitating pain.

Alternatives to Hernia Mesh

  • Shouldice Repair: A two layer suture only hernia repair utilizing the patient’s fascia and tendon.
  • McVay Repair: Abdominal tendons are sutured to the inguinal ligament.
  • Bassini Repair: A suture inguinal hernia repair that preserves the spermatic cord.
  • Desarda Repair: A suture only repair using multiple layers of fascia.

Shouldice Repair

Long before hernia mesh was utilized to repair hernias, surgeons used the shouldice technique to repair hernias. The shouldice technique originated from the Shouldice Hospital in Ontario, Canada, where the technique is still favored to this day. For over 70 years, the Shouldice Hospital has maintained a success rate of 99.5% on primary inguinal hernia repairs. In most cases, general anesthesia is not even necessary to perform the shouldice repair. Typically local anesthetics, pain medication, sutures and a sedative is all that is required. Not having to rely on general anesthesia greatly reduces the risk associated with any surgery. It is time for the surgeons in the United States to start learning the Shouldice technique again while in residency.

When Should Hernia Mesh Never Be Used?

Smaller hernias, such as hernias caused by laparoscopic surgery, don’t require mesh to repair. Small hernias can easily be repaired with sutures by an experienced surgeon. The difficulty with hernias is they are very difficult to permanently repair. There is a high rate of hernia recurrence, both with sutures and with mesh. When sutures fail and the hernia comes back, the surgeon can usually try to stitch the hernia back up. When a mesh fails and the hernia comes back, many severe complications can occur. Also, the hernia is usually much larger after mesh failure. Abdominal tissue and muscle typically adheres to the mesh and must be removed with it.

Types of Hernias

  • Incisional: At an old surgical incision.
  • Umbilical: Near the belly button.
  • Inguinal: Groin.
  • Femoral: High in the thigh.
  • Recurrent: Previous hernia site.
  • Bilateral: Both left and right sides

How do the Manufacturers Convince Surgeons to Use Hernia Mesh?

The manufacturers of hernia mesh products funded studies to demonstrate that there was a lower rate of hernia recurrence when hernia mesh was utilized. These studies were lacking in many ways, such as the length of time that patients were monitored after mesh implantation and what were considered “normal complications.”  Researchers have frequently talked to victims that were implanted with mesh 10 or 15 years ago and have just recently suffered from the mesh eroding into their bowels. Hernia recurrences and complications that happen 10 years later aren’t captured by the studies.

How Bad are Hernia Mesh Complications?

Unlike sutures, which have relatively few and minor possible complications, hernia mesh frequently causes life-threatening complications. Hernia mesh can erode into the bowel, requiring multiple additional surgeries, weeks of hospitalization, partial bowel removal, colostomies, and more. The mesh failure frequently causes patients to experience a systemic infection. We recently observed high rates of dental infections associated with mesh failure. Many victims report all of their teeth suddenly rotting out. Even if there is a slightly lower rate of hernia recurrence when mesh is used, it doesn’t justify the risk of life-threatening complications.

 Hernia Mesh Injuries and Complications

Hernia mesh is used to repair both ventral hernias and inguinal hernias. Various injuries and complications can occur depending on what part of the body the mesh is placed. A coated hernia mesh is also more likely to cause injuries such as infection than a non-coated hernia mesh. The follow is a list of the array of complications we observed:

  • Infection, including sepsis. An infected hernia mesh almost always requires removal.
  • Adhesions form to connect the bowel to the hernia mesh. Adhesions frequently form when ventral hernias are repaired with a coated mesh.
  • Bowel Obstruction caused by adhesion formation. Evidenced by a change in bowel habits or the inability to defecate.
  • Abdominal Pain is a sign of possible adhesion formation, a bowel obstruction, infection, or nerve damage.
  • Rashes are commonly observed in association with hernia meshes such as the C-Qur V-Patch and Ventralex ST.
  • Leg, Groin, and Testicular Pain are all common to inguinal hernias repaired with mesh. This pain can be debilitating.
  • Pain with Sex (Dyspareunia) caused from the mesh used to repair an inguinal hernia attaching to the spermatic cord.
  • Testicle Removal may be necessary if the mesh erodes far enough into the spermatic cord.
  • Diarrhea can be an early symptom of the mesh attaching to the bowel.
  • Constipation can be a sign of a bowel obstruction. You should consult a doctor if your constipation persist for several days.
  • Nausea can be an additional sign of adhesions to the bowel and stomach.
  • Seroma is a fluid capsule surrounding the mesh. Seromas can be present with and without infection.
  • Fistula. An abnormal tunnel between two structures. Our attorneys observe many fistulas connecting to the bowel, which are associated with infections.
  • Dental Problems. Medical reviewers have observed a large number of patients who have lost their teeth after a hernia mesh infection.
  • Autoimmune Disorders. An alarming number of our patients have developed autoimmune disorders after being implanted with a pelvic or hernia mesh.
  • Neurological Changes. Several different patients that have been implanted with the same type of mesh have been diagnosed with unexplained neurological changes on a CT scan.
  • Severe Headache. Typically a sign of a larger problem, such as an infection.
  • Fever. Associated with both an autoimmune response to the mesh and infection.
  • Renal Failure has been observed in those implanted with large coated meshes. The coatings are absorbable and put a great deal of strain on the kidneys.
  • Liver Abnormalities have also been documented in those implanted with coated hernia meshes. The liver is also responsible for cleansing the body.
  • Joint Aches and Pain can be caused by increased systemic inflammation due to infection and an autoimmune reaction to the mesh.
  • Abnormal Sweating can be related to an autoimmune response or to an infection.
  • Meshoma is the migration, contracture, or bunching-up of an artificial mesh. Meshomas become hard, tumor-like bodies.

Too Many Lawyers and Surgeons Rely on Out of Date Hernia Mesh Studies

Polypropylene can cause damage to the surface of any organ it is touching. Old literature and scientific studies found that polypropylene was safe for hernia repair, and only caused severe complications when used as a pelvic mesh. This is why most attorneys have, and still refuse to take hernia mesh cases. The old literature and scientific studies are no longer valid though. Over time, surgeons began to insert and secure hernia mesh via laparoscopic procedures. When a hernia is repaired with mesh laparoscopically, some surgeons insert the mesh deeper into the abdominal cavity, which causes the mesh to come in contact with the bowel. When polypropylene comes in direct contact with the bowels, severe complications typically arise. Due to the now widespread utilization of laparoscopic intraperitoneal hernia repair with mesh, the old scientific studies are no longer valid.

Why Do So Many Hernia Mesh Products Have Coatings Now?

As intraperitoneal laparoscopic hernia repair surgeries with mesh increased, so did the severe complications. The hernia mesh manufacturers scrambled to create a new hernia mesh that would fix the problem polypropylene was causing. However, any material other than polypropylene would have to undergo FDA Pre-Market Approval (PMA). In order to gain PMA status (which also makes the company immune from lawsuits), the company would have to conduct pre-clinical studies to prove that the hernia mesh was safe. Instead, the manufacturers began to apply various types of coatings to the mesh. The idea was that the coating would create a layer between the bowel and the polypropylene. Most of these coatings are intended to be absorbed by the body over a period of months to years.

Differences in Mesh Placement

  • Overlay– The hernia mesh is placed between the skin/subcutaneous tissue and the rectus abdominis. Mesh is easiest to remove when it is placed in the overlay position.
  • Inlay– The hernia mesh is placed between layers of the rectus abdominis.
  • Underlay– The hernia mesh is placed between the rectus abdominis and the peritoneum. The hernia mesh has a higher chance of attaching to the patients underlying organs when placed in the underlay position.

Composite Mesh: The Most Dangerous Type of Hernia Mesh

Any mesh with a coating is known as a composite mesh. Most of the manufacturers promote the meshes coating as a “barrier” and instruct surgeons to use the coating as a barrier. The FDA requires any “barrier” type of medical device to undergo Pre-Market Approval and pre-clinical studies to ensure the device’s safety. Instead of conducting safety studies, companies just told the FDA that they wouldn’t promote their hernia mesh as a “barrier.” A majority of the meshes currently being used in hernia repair are untested composite meshes that have only been on the market for a few years. There is currently no reliable data on these hernia mesh products. Medical reviewers are currently noticing a very high rate of complications associated with hernia meshes that are coated.

Big Profits Making Composite Mesh

Due to the complications that polypropylene was causing when it came in direct contact with the bowel, the demand for composite hernia mesh skyrocketed. Any company with a composite mesh could rapidly increase its nationwide market share. Mesh products were already one of the most profitable medical devices a company could manufacture, many making over $100,000,000 a year! A composite mesh also sells for approximately 15 – 20 times more than an uncoated polypropylene mesh. Suddenly, every device manufacturer rushed to get a composite mesh on the market. Many companies created and sold several different types of composite hernia mesh at the same time. If one type of composite mesh caused too many side effects, the company would simply quit manufacturing that particular composite mesh. There are currently over 350,000 hernia repairs in the United States each year.

Current Hernia Mesh Lawsuits and Investigations

There are many different hernia mesh products available, many of which are manufactured by different medical device companies. The strengths and weaknesses of a hernia mesh lawsuit are in part determined by which company manufactured the hernia mesh and the exact mesh that was utilized. Below is a list of products that have received a large number of complaints. Bookmark this page and check back soon, this list is growing and we continue to add more unique content every week!

Ethicon – Johnson & Johnson

Proceed Hernia Mesh

The Proceed hernia mesh came to market in 2003. The Proceed is a light-weight hernia mesh with an Oxidized Regenerated Cellulose (ORC) fabric covering the polypropylene. The cellulose is adhered to the polypropylene with polydioxanone (PDS). Ethicon touts the Proceed’s barrier as supporting “safe and comfortable healing.” Ethicon has previously issued limited recalls on the Proceed hernia mesh, because of the cellulose layer separating from the polypropylene and increasing the risk of bowel complications. The Proceed hernia mesh continues to delaminate and should be permanently recalled. Physicians have submitted 100’s of adverse event reports to the FDA and Johnson & Johnson regarding the Proceed hernia mesh being defective and injuring patients.

Physiomesh

The Physiomesh was withdrawn from the market in May of 2016. Ethicon maintains that they did not recall the Physiomesh. The Physiomesh was a composite hernia mesh. Multiple studies revealed that Ethicon’s Physiomesh had high rates of complications, including subsequent hernias and additional surgeries. Ethicon admitted that they’re unable to determine why the Physiomesh is defective, or how to decrease complications for those who had a Physiomesh implanted. Part of the problem was likely that the Physiomesh had a coating on each side of the mesh. The coating prevented the Physiomesh from properly incorporating with the host tissue. Prior to removing (not recalling) the Physiomesh from the market, Ethicon created a new hernia mesh called Physiomesh Open.

Prolene Hernia System

The Prolene Hernia System (PHS) was introduced to the market in 1997. The Prolene Hernia System is similar to polypropylene mesh plugs with a polypropylene onlay. In fact, the Prolene Hernia System cites Bard’s Perfix plug as a predicate device. Our hernia mesh lawyers have observed similar complications associated with the Prolene Hernia System and the Perfix plug. The Prolene Hernia System utilizes heavy-weight polypropylene. In 2007, Ethicon came out with the Ultrapro Hernia System, a light-weight version of the Prolene Hernia System. Light-weight polypropylene was believed to cause less complications than heavy-weight polypropylene. Injuries associated with the PHS include debilitating pain, nerve damage, and sexual dysfunction necessitating testicle removal.

Covidien – Medtronic

Parietex

The Parietex hernia mesh was Covidien’s first polyester hernia mesh. The Parietex originally came to the market in 1999 as a heavy-weight polyester mesh. The original Parietex caused many problems similar to polypropylene based hernia meshes, such as adhesions, infections, and bowel complications. Like polypropylene, polyester also shrinks and contracts to a significant degree after it is implanted in the body. As the Parietex contracts, tension increases and the mesh has a tendency to tear where the tacks or sutures were used to secure it. Severe pain and a recurrence of the hernia typically result when the Parietex mesh rips apart. After the Parietex detaches it can migrate to other parts of the body.

Parietex Composite Mesh

The Parietex Composite (PCO) mesh is composed of a polyester base with a resorbable collagen barrier. The resorbable collagen barrier is intended to prevent the polyester base from adhering to the patient’s bowel. Covidien touts the Parietex as a unique material that “works with the body’s natural systems.” However, many of our clients would disagree. The collagen layer of the Parietex Composite hernia mesh is very thin and delicate. The collagen layer disappears quickly after implantation and does little to nothing to protect the bowel and underlying organs from the polyester base. Recently, Covidien came out with the Parietex Optimized Composite Mesh in an attempt to fix the problems associated with the collagen layer. The hernia mesh lawyers at the Hollis Law Firm frequently see severe adhesions, bowel obstructions, and infections associated with the Parietex Composite hernia mesh. Additionally, like the original Parietex, the Parietex Composite tears easily on sutures or tacks as it begins to contract post implantation.

Parietex ProGrip / Parietex Plug and Patch System

The Parietex ProGrip and the Parietex Plug and Patch System are made from polyester weaved together with a partially semi-resorbable polylactic acid (PLA) layer. The Parietex ProGrip is a “self-fixating” mesh because it has thousands of hooks that are intended to keep the mesh in place. However, the thousands of hooks also cause patients to experience severe pain and make the hernia mesh nearly impossible to remove. When the Parietex ProGrip fails and complications result, multiple surgeries are usually required to remove the underlying problem: the defective Parietex ProGrip hernia mesh. Covidien was recently acquired by Medtronic for nearly $50 billion. Covidien is also one of many defendant mesh manufacturers in the pelvic mesh litigation

Atrium – Maquet – Getinge Group

C-Qur Hernia Mesh

The C-Qur is a composite hernia mesh that came to market in 2006, and was initially marketed by Atrium Medical Corporation. Maquet, a subsidiary of the Getinge Group, acquired Atrium in 2011 and now manufactures the C-Qur hernia mesh. The FDA has issued several warnings letters and even sued Atrium Medical Corporation for violations. Recently, the FDA shut down one of Atrium’s facilities that manufactured the C-Qur hernia mesh. Atrium has only issued recalls on the C-Qur’s packaging, not on the actual C-Qur hernia mesh itself.

The C-Qur hernia mesh has an Omega-3 Fatty Acid coating that causes severe allergic reactions. The C-Qur hernia mesh is also associated with life-threatening systemic infections. Removing the C-Qur mesh is extremely difficult and can result in further injury. The C-Qur hernia mesh remains on the market, even as lawsuits continue to mount. Our hernia mesh recall lawyers continue to receive frequent complaints related to the C-Qur hernia mesh.

Davol – C.R. Bard

Kugel Hernia Mesh

The Kugel hernia mesh was one of first and most well known hernia meshes to be recalled. C.R. Bard recalled several lots of the Kugel hernia patch in 2005, 2006 and 2007. The Kugel hernia mesh patch has a ring in the middle of the mesh to help it keep it’s shape. Multiple lots of the Kugel hernia mesh were recalled due to a large number of reported ring breaks. Many patients have suffered bowel perforations as a result of the inner ring of the Kugel hernia patch breaking. Davol only recalled limited lots of the Kugel, claiming that certain lots had defective rings. Davol continues selling the Kugel hernia mesh to this day. The real problem with the Kugel hernia mesh is that it’s made of polypropylene, which shrinks over time. As the polypropylene mesh shrinks, more and more force is applied to the ring. Eventually, the ring breaks due to the shrinkage of the polypropylene.

3DMax

The 3DMax is a bare heavy-weight polypropylene mesh used to treat inguinal hernias. In 2008, Bard released a light-weight version of the 3DMax called the 3DMax light. Patients nationwide have experienced severe, debilitating pain after being implanted with the Bard 3DMax mesh. The 3DMax mesh can erode through soft tissue and then attach to the spermatic cord in men, causing severe sexual dysfunction and testicle pain. Once the mesh is attached to the spermatic cord, there is a risk of losing the testicle when removing the mesh. The 3DMax is curved, and is intended to be implanted without any sutures or tacks. Our hernia mesh attorneys have identified many cases where the Bard 3DMax has folded over upon itself and migrated inside the patient. As can be seen in the picture, the outer sealed edge of the 3DMax also has a tendency to easily break and tear. The sealed edge is intended to help the 3DMax maintain its shape. Bard’s 3DMax simply is not fit for permanent, life-long human implantation.

PerFix Plug

The PerFix Plug is a bare polypropylene mesh used to treat inguinal hernias. The PerFix Plug looks like a double layer dart with an overlay patch. The polypropylene of the PerFix Plug has been observed to come unwoven over time. Many experience severe pain and difficultly exercising and even walking after being implanted with the Bard PerFix Plug. The PerFix Plug is another hernia mesh that has caused many men to loose a testicle. The PerFix Plug is not necessary to repair an inguinal hernia.

Ventralex ST Hernia Mesh (Sepramesh)

In 2007, Bard bought the license to Sepramesh from Sanofi Genzyme. The Sepramesh was intended to “Separate the polypropylene from the bowel.” Bard then created the Ventralex ST hernia mesh by combining the Sepramesh and the Kugel mesh. Bard recalled several lots of the Kugel hernia mesh approximately a decade ago. Bard has yet to issue a recall on any lot of the Ventralex ST hernia mesh.Bard also claims that the Ventralex ST hernia mesh’s coating is similar to the coating used on the C-Qur hernia mesh. Like with the C-Qur, researchers are seeing severe inflammatory reactions, infections, and adhesions related to the Ventralex ST. Please note that Sepramesh, Ventrio ST and Ventralight ST are also included in the Ventralex ST lawsuit.

Scientific Articles on Hernia Mesh

The below articles are on hernia mesh in general. Each hernia mesh subpage also contains additional case specific scientific articles.

August 2016: Evaluation of Long-Term Surgical Site Occurrences in Ventral Hernia Repair: Implications of Preoperative Site Independent MRSA Infection.

632 patients were studied for two years after being implanted with hernia mesh. 31% experienced complications within just two years. Complications included cellulitis, necrosis, nonhealing wound, seroma, hematoma, dehiscence, and fistula. Patients with a preoperative MRSA+ infection from any site (urine, blood, surgical site), might be at an elevated risk for hernia mesh complications.

August 2016: Oral, Intestinal, and Skin Bacteria in Ventral Hernia Mesh Implants.

36 patients with failed hernia mesh were studied. All participants were found to have gingivitis and 33% had infected gums and teeth. Oral bacteria was discovered on 43% of explanted hernia mesh. The study discusses the difficulty in knowing the real rate of hernia mesh infections, due to lack of standardized criteria to define infection, lack of follow-up exams, and lack of intervention when complications arise. It notes that hernia mesh infection is the most common reason for mesh removal.

June 2016: Sepramesh and Postoperative Peritoneal Adhesions in a Rat Model.

The study notes that “postoperative peritoneal adhesions occurred at the extremities of the mesh, where there was close contact between the polypropylene and viscera, or where the fixation suture was placed.”

August 2015: Previous Methicillin-Resistant Staphylococcus Aureus Infection Independent of Body Site Increases Odds of Surgical Site Infection after Ventral Hernia Repair.

768 patients underwent hernia repair. 10% experienced a hernia mesh infection. 33% of patients with a preoperative MRSA+ infection experienced a hernia mesh infection.

May 2014: Comparison of Outcomes of Synthetic Mesh vs Suture Repair of Elective Primary Ventral Herniorrhaphy: A Systematic Review and Meta-Analysis.

637 hernia mesh repairs and 1145 suture repairs were compared. Hernia mesh repair was associated with a slightly lower rate of recurrence, but a higher rate of severe complications. The authors admit that “further high-quality studies are necessary to determine whether suture or mesh repair leads to improved outcomes for primary ventral hernias.”

November 2013: Coated Meshes for Hernia Repair Provide Comparable Intraperitoneal Adhesion Prevention.

Uncoated polypropylene was compared to various types of coated polypropylene placed intraperitonally via laparoscopic procedure. The uncoated polypropylene hernia mesh resulted in significantly more adhesions.

October 2013: Biologic Meshes are Not Superior to Synthetic Meshes in Ventral Hernia Repair: An Experimental Study with Long-Term Follow-Up Evaluation.

The study notes that “In laparoscopic incisional hernia repair, direct contact between the prosthesis and the abdominal viscera is inevitable, which may lead to an inflammatory reaction resulting in abdominal adhesion formation.” The authors advise additional research is necessary, and to be wary of short-term experimental results on laparoscopically placed hernia mesh.

October 2013: Intra Peritoneal Polypropylene Mesh and Newer Meshes in Ventral Hernia Repair: What EBM Says?

The authors are concerned about using polypropylene mesh (PPM) for laparoscopic hernia repair. They question if paying 15-20 times more for a composite mesh is worth it. The study notes “Complications of intraperitoneal PPM (adhesions, infection, intestinal fistulization, sinus formation, seroma and recurrence) can occur with the newer mesh also. There is no statistically significant difference in the incidence of these complications between these meshes.”

August 2012: Ventral Hernia Repair with Synthetic, Composite, and Biologic Mesh: Characteristics, Indications, and Infection Profile.

The study notes that polypropylene “is unsuitable for intra-abdominal placement because of its tendency to induce bowel adhesions.”

August 2011:  Complications of Mesh Devices for Intraperitoneal Umbilical Hernia Repair: A Word of Caution.

The surgeons note experiencing serious complications in several patients implanted with a composite mesh. Injuries included small bowel resections and mesh removal. The study notes “We think that, if preperitoneal deployment of such mesh devices is possible, this should be the preferred position, notwithstanding the fact that these meshes have a dual layer. There is a complete lack of convincing data on these mesh devices in the medical literature. No long-term data have been published, and, for three of the four mesh devices available, no publications on their use in humans were found.”

July 2011: Mesh Infection in Ventral Incisional Hernia Repair: Incidence, Contributing Factors, and Treatment.

The study discusses the need for a better identification, classification and reporting systems for hernia mesh infections. It notes part of the difficulty is that hernia mesh implants have a tendency to remain dormant for long periods of time. It can take years before a hernia mesh infection is identified.

January 2010: Oral Biofilms: Emerging Concepts in Microbial Ecology.

The overall health and biology of an individual is closely linked to which oral biofilms develop.

June 2009: The Problem of Mesh Shrinkage in Laparoscopic Incisional Hernia Repair. 

Laparoscopic hernia repair requires expanding the abdomen with approximately 3 liters of gas. The surface area of the abdominal wall is stretched by about 80% during laparoscopic repair. Surgeons must anticipate significant mesh shrinkage in laparoscopic hernia repair. Mesh shrinkage remains one of the unsolved problems of laparoscopic incisional hernia repair.

How Does the FDA Learn About Hernia Mesh Complications?

If a hernia mesh fails within a few years and the same surgeon that implanted the mesh removes the mesh, the surgeon will sometimes report the complication to the manufacturer. It is then the manufacturers duty to determine if the complication warrants notifying the FDA. Through our investigations, we uncovered that many manufacturers fail to report adverse events related to hernia mesh to the FDA. Surgeons will also occasionally file adverse event reports directly to the FDA, but the process is very time consuming. As a result, the FDA is only aware of a very small percentage of total hernia mesh complications. The manufacturers of hernia mesh then cite to low rates of hernia mesh complications reported to the FDA as evidence that hernia mesh is safe!

Are There Other Ways to Report Hernia Mesh Complications to the FDA?

If you have suffered hernia mesh complications, you can alert the FDA through a MedWatch Report. You can also alert the FDA by filing a hernia mesh lawsuit against the manufacturer of the mesh. When a manufacturer is notified of a pending hernia mesh lawsuit, the manufacturer must report the basis of the hernia mesh lawsuit to the FDA. Medical device companies are allowed too much discretion on if they have to notify the FDA when a surgeon reports a hernia mesh adverse event. The medical device companies do not have discretion on reporting a hernia mesh lawsuit to the FDA. The companies must report every single hernia mesh lawsuit to the FDA.

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