Australian Survey Finds that 58% were Injured by Pelvic Mesh Implant

HIC CEO, Danny Vadasz
HIC CEO, Danny Vadasz says “This is a significant public health problem which has been grossly underestimated — in terms of numbers of women as well as the severity of resultant health problems.”

Problems caused by transvaginal mesh have been grossly under-estimated, according to a new survey by an Australian Health Issue Center.

  • Of these, a shocking 58% say they have been adversely impacted, citing problems such as chronic incontinence, abdominal pain, and pain during intercourse. Sadly, for a quarter of these women, the impact of the implants has led to a breakdown of their marriages or personal relationships.
  • Just 38% of the respondents believe they made an informed choice to have the procedure.
  • Of the women who sought remedial medical help, slightly over 10% reported this made things better while 40% reported it made no difference and 11%, that it made matters worse.
  • The remaining 39% were told that nothing could be done for them.

In just three weeks, 1,250 women completed the online Facebook survey targeting the thousands of women nationwide who have undergone pelvic mesh implants to treat stress urinary incontinence and pelvic organ prolapse.

In the US, there are 80,000 lawsuits against the manufacturers or transvaginal mesh in eight MDLS:

A catastrophic failure

Commenting on the overwhelming response to the survey, HIC CEO, Danny Vadasz, says he has no idea ‘how much of the iceberg has been revealed’ so far but believes there could be considerably more given that HIC is currently averaging over 100 survey responses per day.

“Even if we were to receive no further responses, I think we have already demonstrated that this is a significant public health problem which has been grossly under-estimated — in terms of numbers of women as well as the severity of resultant health problems.

HIC is a not for profit consumer health advocate based in Victoria, Australia, which encourages better health outcomes by encouraging consumers to become involved in their own health care and ensuring the health system is responsive to their needs.

“What we are seeing is a catastrophic failure at all levels of the health system to protect the well-being of thousands of women – the lack of due diligence by the TGA in approving the device given the risks; culpability of manufacturers who despite plenty of evidence of adverse reactions overseas, continue marketing their products; the government which does not have a central register of how many procedures have occurred and how many products have been sold and finally, those surgeons who continue to practise the procedure without informing their patients of the risks and the irreversibility of the implant.

“Clearly a lot of questions need to be asked!”

Vadasz says while transvaginal mesh has been seen by the medical fraternity as having ‘revolutionised’ surgical options for women with stress urinary incontinence and pelvic organ prolapse, the collateral damage for women when it goes wrong, is just too high. “We are calling for the classification of mesh to treat either of the conditions to be upgraded to a higher risk status so the patient consent process reflects the consequences when there are complications.”

Unaware that mesh caused injuries

Despite the number of women coming forward, Vadasz believes that the problem will continue to go underreported given that many women do not associate their symptoms with their mesh implants. On top of this, many have been told by doctors there is no causal relationship.

“This has been borne out by the significant number of survey respondents who told us they were unaware that the pain and problems they had suffered for many years could be linked to their mesh implant. Some have cried at the realization with one woman declaring, ‘Now I know I’m not crazy’.”

Here are some of the more harrowing comments on the HIC Facebook page:

“My specialist told me it was all in my head. He got angry with me and said: “I suggest you stop focussing on the vagina, and get on with your life” in a dismissive and irritated tone. Doctors I have seen since have not been forthcoming on what they can see, it is like they are trying to protect the medical fraternity by not telling me fully what is going on or helping me fine treatment.”

“I was told the mesh cannot be removed. I had complications from the moment I came out of theater. I needed a complete reconstruction but was refused and offered the TVT as part of a study or to put up with consequences of a grossly oversized baby that was a face presentation and a complete episiotomy after he became stuck. I now suffer urge incontinence and a partial vaginal prolapse. I wish I’d never had the TVT done!”

 Vadasz is calling on women who have had an implant (or believe they may have) to complete the HIC survey: https://www.facebook.com/pg/UnderstandingPelvicMesh/about/

About the survey

The Health Issues Centre is one of several organizations invited to give input into the senate inquiry into the extent and impact of Transvaginal Mesh Implants (TVM) across Australia. Currently there is little information about the number of women who have undertaken the procedure and less about those who have suffered from side-effects. In order to understand the size of the problem and gain insight into the impact on these women, the consumer health advocacy conducted a highly targeted nationwide survey.

Using the center’s Facebook page to create interest and an online survey, the survey targeted 14,000 women nationally. The questions are as follows:

·       Have you undergone a transvaginal mesh, tape or sling implant as treatment for urinary incontinence or pelvic organ prolapse?

·       Do you continue to have undiagnosed symptoms of chronic abdominal pain or urinary incontinence?

·       Do you feel you were fully informed before agreeing to the procedure?

·       Did the procedure satisfactorily resolve your health concerns?

·       Could you specify any adverse impacts you may have experienced?

·       How would you rate this adverse impact – discomforting, severe, debilitating, unendurable, none of these.

·       Have you sought medical assistance to rectify the problem?

·       Did your doctor/specialist confirm a causal relationship between your symptoms and the mesh implant?

·       If you were offered remedial treatment, did it change your condition?

While launched only three weeks ago, 20,000 have engaged with the survey and 1,250 surveys have been completed. Over 14,000 people have viewed the Facebook video.

 

 

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New Research: IVC Filters Don’t Save Lives in Trauma Patients

Bard Denali IVC Filter
Bard Denali IVC Filter

New research in JAMA Surgery concludes that IVC filters don’t save lives in trauma patients, who are at increased risk of bleeding and thrombosis, and the devices should not be placed in trauma patients in an effort to decrease all-cause mortality.

“The research herein demonstrates no significant difference in survival in trauma patients with vs without placement of an IVC filter, whether in the presence or absence of venous thrombosis. The use of IVC filters in this population should be reexamined because filter removal rates are low and there is increased risk of morbidity in patients with filters that remain in place,” the study concludes.

See Association Between Inferior Vena Cava Filter Insertion in Trauma Patients and In-Hospital and Overall Mortality by Shayna Sarosiek, MD, Denis Rybin, PhD, Janice Weinberg, ScD, Peter A. Burke, MD, George Kasotakis, MD, and J. Mark Sloan, MD.

Should not be placed in trauma patients

“The use of IVC filters in this population should be reexamined because filter removal rates are low and there is increased risk of morbidity in patients with filters that remain in place,” the researchers said. “Given the expected morbidity of long-term IVC filter use, filters should be removed as soon as a patient’s contraindication to anticoagulation resolves.”

“Overall, these data indicate that IVC filters should not be placed in trauma patients in an effort to decrease all-cause mortality.”

Litigation against the makers of IVC filters is one of the largest mass torts today. “All these products are defective,” Mass Tort Consultant John Ray said, speaking in a webinar presented by The National Trial Lawyers. “I cannot say that one product is less defective than other.”

  • There are 886 cases in Bard IVC Filter Litigation in MDL 2641 before Judge David G. Campbell in US District Court in Arizona.
  • There are 993 cases in Cook Medical IVC Filter Litigation in MDL 2570 before Chief Judge Richard L. Young in US District Court for the Southern District of Indiana. The defendants are Cook Medical, LLC and Cook Inc., both of Bloomington, IN, and William Cook Europe APS, Bjaeverskov, Denmark.
  • Cordis IVC Filter Litigation is centered in the California state courts, where hundreds of cases are up for consolidation. Cordis Corporation is organized under the laws of Florida, with its principal place of business in Fremont, California.
  • There is no MDL for Boston Scientific Corp IVC Filter Litigation. “We believe it is possible that more cases will be filed and a motion for consolidation and transfer may be formed in an effort to form an MDL,” says Ray.
  • Similarly, there is no MDL for cases against Rex Medical and Argon Medical. Plaintiffs have filed cases in the Philadelphia Court of Common Pleas before Judge Arnold New, who has assigned them to the complex litigation track.

Venous thromboembolism is a significant cause of death in the United States. Approximately 900,000 patients per year have a clinically significant deep vein thrombosis or pulmonary embolism. Since the invention of the permanent percutaneous IVC filter in 1973 and the retrievable IVC filter in the 1990s, its use has become a standard part of treatment for select patients with acute lower-extremity venous thrombosis who cannot receive anticoagulation.

 

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IVC Filter Cases Settling Quietly as Litigation Grows

ivc filter2Manufacturers of defective IVC filter medical devices are settling cases behind the scenes, as litigation is building nationwide. The blood clot filters have been inserted in millions of patients over the last 40 years.

“All these products are defective,” said mass tort expert John Ray of Ft. Lauderdale, speaking in a webinar presented by The National Trial Lawyers. “I cannot say that one product is less defective than other.”

While specific settlements are suppressed by non-disclosure agreements, Ray said that a wrongful death case involving an IVC filter has a settlement value of $500,000. At the other extreme, a case involving the successful removal of an IVC filter without complications has a settlement value of $10,000.

  • Bard IVC Filter Litigation is consolidated in MDL 2641 in US District Court in Arizona. Bard essentially announced that it was settling cases in its September 2015 10-Q filing, where it stated, “While the company intends to vigorously defend Filter Product Claims that do not settle, including through litigation, it cannot give any assurances that the resolution of these claims will not have a material adverse effect on the company’s business…”  Ray says, “Bard has issues that will cause it to settle sooner rather than later. Bard got a lot of bad press about what they knew and when they knew it. Bottom line, Bard is going to settle, and they threw up the white flag in this statement to stockholders.”
  • Cook Medical IVC Filter Litigation is consolidated in MDL 2570 in US District Court for the Southern District of Indiana. The defendants are Cook Medical, LLC and Cook Inc., both of Bloomington, IN, and William Cook Europe APS, Bjaeverskov, Denmark. “There are many stipulated dismissals where no motion to dismiss has been filed,” Ray says. “Generally when you see this, the company is settling cases, but doing so privately. Will there be a mass settlement? Probably. But I am 99% sure that they have already settled a lot of cases.”
  • Cordis IVC Filter Litigation is centered in the California state courts, where hundreds of cases are up for consolidation. Cordis Corporation is organized under the laws of Florida, with its principal place of business in Fremont, California. According to Ray, plaintiffs can file cases there regardless of the original jurisdiction.
  • There is no MDL for Boston Scientific Corp IVC Filter Litigation. “We believe it is possible that more cases will be filed and a motion for consolidation and transfer may be formed in an effort to form an MDL,” says Mass Tort Consultant John Ray.
  • Similarly, there is no MDL for cases against Rex Medical and Argon Medical. Plaintiffs have filed cases in the Philadelphia Court of Common Pleas before Judge Arnold New, who has assigned them to the complex litigation track.

How were defective devices approved?

Ray said he solved the puzzle about how a group of medical devices so inherently defective won approval from the FDA. “It was a matter of timing,” he says. The first IVC filters were on the market prior to regulation by the Medical Device Act of 1976. The first IVC filter was approved using the 510(k) shortcut. “Once the first device was approved, every other device had a predicate device. They were all approved without ever being tested, without proving their satefy, without proving their efficacy.”

IVC filters are small, cage-like devices that are inserted into the inferior vena cava – a major vein leading directly to the heart. They were supposed to capture blood clots and prevent them from reaching the lungs.

However, attorney John Dalimonte of Boston identified three issues with the Cook Tulip and Celect IVC Filters.

  • Migration downward and upward. The IVC Filters can tilt or shift, making them almost impossible to remove.
  • Device fracture, causing blood clots (embolism) in the heart, lung, liver and kidneys. Research shows that the devices experienced fracture rates of 37% to 40% after five and a half years.
  • Perforation, where stress on the IVC Filter struts leads to fractures that puncture adjacent organs and vessels.

“There are a lot of cases out there,” Dalimonte says, because the manufacturers conducted off-label marketing directly to bariatric patients, trauma patients and orthopedic surgery patients.

He will be part of the panel of the September Mass Tort Nexus Course. John serves on the Steering Committee for the Bard and Cook MDLs. Contact barbara@masstortnexus.com or (954) 383-3932 for information on the September Course.

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Cook IVC Filter Settlement Talks Fail

Cook Celect® IVC Filter
Cook Celect® IVC Filter

U.S. Magistrate Judge Tim Baker met with attorneys for both sides of the Cook IVC Filter litigation to discuss a settlement, but they did not find common ground, according to the Daily Hornet.

The conference ended “without further order,” according to a statement from the court.

There may be other settlement conferences, but the lawsuits will go to trial if negotiations fail. Large-scale settlements become more likely if a jury awards compensation. If not, the cases could be dismissed or sent to a lower court.

818 cases pending

As of August 15, Cook Medical was facing 818 federal lawsuits in Multi-District Litigation in Indiana. U.S. District Judge Richard Young ordered that three IVC filter cases pending against Cook Medical go to trial in 2017. The cases will be tried in MDL No. 2570 IN RE: Cook Medical, Inc., in the Southern District of Indiana.

Judge Young on July 19 identified three trial plaintiffs and types of filter:

  • Brand v. Cook Medical, Inc. et al., Case No. 1:14-cv-6018 (Celect)
  • Gage v. Cook Medical, Inc. et al., 1:14-cv-1875 (Günther Tulip)
  • Hill v. Cook Medical, Inc., et al, 1:14-cv-6016 (Celect)

Hundreds of Cook and Cordis IVC Filter cases are already filed, and hundreds of thousands of potential clients nationwide who need attorneys.

The cause of the litigation is the rapacious greed of the two companies competing to get market share, rolling out one defective product after another for the last 16 years, brushing aside reports of patient deaths and lying to the FDA about it.

  • Cordis IVC Filter Litigation is centered in the California state courts, where hundreds of cases are up for consolidation. Cordis Corporation is organized under the laws of Florida, with its principal place of business in Fremont, California.
  • Bard IVC Filter Litigation is consolidated in MDL 2641 (multi-district litigation docket) in US District Court in Arizona.
  • Cook Medical IVC Filter Litigation is consolidated in MDL 2570 in US District Court for the Southern District of Indiana. The defendants are Cook Medical, LLC and Cook Inc., both of Bloomington, IN, and William Cook Europe APS, Bjaeverskov, Denmark. The federal district court has created a short form complaint.
  • There is no MDL for Boston Scientific Corp IVC Filter Litigation. “We believe it is possible that more cases will be filed and a motion for consolidation and transfer may be formed in an effort to form an MDL,” says Mass Tort Consultant John Ray.

 

 

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FDA Warns Public about Dangerous IVC Filter Side Effects

Bard Denali IVC Filter 2013
Bard Denali IVC Filter 2013

In a public safety communication, the U.S. Food and Drug Administration (FDA) says it has received approximately 920 adverse event reports related to the use of IVC filters, It issued a public report to inform medical professionals and patients about the potential risks associated with using the small, cage-like device. Adverse events reported by the FDA include:

  • Filter fracturing of the device
  • Migration of the pieces
  • Embolization of fractured device or device components
  • Tearing of the inferior vena cava vein.

Cordis IVC Filter Litigation is consolidated in California State Court. Bard IVC Filter Litigation is consolidated in MDL 2641. Cook Medical IVC Filter Litigation is consolidated in MDL 2570.

There is no MDL for Boston Scientific Corp IVC Filter Litigation. “We believe it is possible that more cases will be filed and a motion for consolidation and transfer may be formed in an effort to form an MDL,” said Mass Tort Consultant John Ray.

According to one of the many product liability cases filed against IVC Filter manufacturers:

“Defendants knew or should have known that its Cook Filter when used as expected and intended, had the possibility of shifting, breaking free its implantation site, migrating, perforating the vena cava, and causing serious injury and/or death to patients.”

The case is Olenda Homes et al. v. Cook Medical Inc. et al. (Case No. 5:16-cv-00066).

Patients who cannot use traditional blood-thinning drugs are usually the typical users of IVC filters. The devices are surgically implanted into a patient’s inferior vena cava vein and are designed to catch blood clots from the legs before they migrate to the heart and lungs, which could cause a pulmonary embolism if it reached these important organs. The filters are meant to only be used temporarily, according to the FDA, and hold the clot until it naturally disappears and until the threat of blood clots is no longer an issue.

IVC filters have come under more intense scrutiny and have been the subject of many lawsuits due to allegations that they have fractured with pieces subsequently migrating away from the original insertion point to other parts of the body. The pieces can tear veins and organs, and embed in other “high risk” areas of the body where they cannot be surgically removed, thus causing significant and long-term risks for the patient.

In its report, the FDA identifies a number of potential symptoms of migrating pieces that patients should be on guard for that include out of the ordinary heart rhythms, dizziness, fainting, heart palpitations, and chest pain.

 

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Hundreds of Cordis IVC Filter Cases Up for Consolidation in California State Court

Cordis TrapEase IVC Filter
Cordis TrapEase IVC Filter

California plaintiffs in litigation against the Cordis Corporation have moved to consolidate 140 cases that charge that its TrapEase and OptEase IVC caused life-threatening injuries. A hearing is set for June 28 in state court in Alameda County.

Judge Brad Seligman will rule on whether to consolidate and set up a bellwether-trial process. The lead case is Jerry Dunson v. Cordis Corporation, Case No. RG16812476. Some 140 plaintiffs have file product liability and breach of warranty claims against Cordis, which is headquartered in the county in Fremont, CA.

The motion to consolidate was filed by Ramon Rossi Lopez, Matthew R. Lopez and Amorina P. Lopez  of Lopez McHugh LLP in Philadelphia, PA.

Double the risk

IVC filters are medical devices placed in the inferior vena cava (IVC) to catch blood clots and stop them from traveling to the heart or lungs. The filters have been shown to double the risk of pulmonary embolism, the very condition which they are intended to prevent. Dozens of plaintiffs have filed product liability lawsuits charging defective design, misrepresentation in marketing, failure to warn doctors and patients adequately about the risks of the devices, and refusing to warn that the filters did not work.

Cordis Corporation is a multi-national business that was was a subsidiary of defendant Johnson & Johnson’s and part of the J&J family of companies until October 2015. On October 4, 2015, defendant Cardinal Health, headquartered in Dublin, OH, publicly announced that it acquired J&J’s Cordis business.

IVC filters are marketed as preventing blood clots (called thrombi) from traveling from the lower portions of the body to the heart and lungs. The vena cava is a large vein that returns blood to the heart. In certain people, and for various reasons, thrombi travel from vessels in the legs and pelvis, through the vena cava into the lungs. Often these thrombi develop in the deep leg veins. The thrombi are called “deep vein thromboses” or DVT. Once a thrombus reaches the lungs it is considered a “pulmonary embolus,” or PE.

Risk of fracturing, tilting and perforating

The Defendants designed, manufactured, marketed and sold two versions of its IVC filter:

  • The first Cordis filter was its TrapEase Permanent Vena Cava Filter (“TrapEase filter“), which was and remains a permanent filter, meaning it was intended to be implanted into the body for the life of the patient.
  • Cordis then created its second IVC filter—the OptEase Retrievable Vena Cava Filter (“OptEase filter“), which was initially cleared by the FDA only as a permanent device, but later received clearance for use as an optional or retrievable filter.

The Cordis IVC filters presented an increased risk of fracturing, titling within the inferior vena cava, perforating the wall of the inferior vena cava (frequently penetrating into other organs and tissues such as the aorta and duodenum), and migrating through the body. The Cordis IVC filters employ the same basic design and are constructed of the same materials. The TrapEase filters and the OptEase filters have demonstrated the same problems—namely, they migrate, fracture, perforate, and tilt, and also, studies show that they lack efficacy and, indeed, actually increase the risk of PE.

On this topic, also read:

Bellwether Trials Set for Dangerous IVC Filters by Cook Medical

South Dakota Woman Files Suit after Bard IVC Filter Gets Embedded in Her Organs

750 Lawsuits Filed Against Manufacturers of IVC Filters

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