FDA – Medical Device Reports of Breast Implant-Associated Anaplastic Large Cell Lymphoma: Who Knew and When?

A Litigation Review by Mass Tort Nexus

July 30, 2019

https://www.fda.gov/medical-devices/safety-communications/fda-takes-action-protect-patients-risk-certain-textured-breast-implants-requests-allergan

By Mark A. York 

(Mass Tort Nexus Media) The  Food and Drug Administration (FDA) has received a total of 573 US and global medical device reports (MDRs) of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL).

Since the FDA’s decision, the breast implant business has boomed, now exceeding $1 billion in revenue a year and projected to reach $2 billion by 2025. More than 1.6 million women worldwide received cosmetic breast implants in 2017, including an estimated 345,236 in the U.S., 235,950 in Brazil, 67,478 in Mexico and 54,045 in Italy. As of 2017, breast enlargement was the most common cosmetic surgery in the world.

Link to: FDA criminal-investigations/warning-letters/mentor-worldwide to Alex Gorsky CEO Mentor (J&J) March 18, 2019 -llc-acclarent-573520-03182019

To protect individuals from the increased risk of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), associated with Allergan BIOCELL textured breast implants, the Food and Drug Administration (FDA) requested that Allergan recall its BIOCELL textured breast implants and tissue expanders. Allergan agreed and is removing these products from the global market. The FDA requested that Allergan recall all BIOCELL textured breast implants and tissue expanders marketed in the U.S. based on newly submitted Medical Device Reports (MDRs) reporting worldwide cases of BIA-ALCL and BIA-ALCL-related deaths associated with these devices. Allergan has notified the FDA that it will recall its BIOCELL textured breast implants and tissue expanders from the global market.

What is the connection between textured breast implants and cancer?

Studies have shown that patients with textured implants face a higher risk of a rare form of cancer called breast implant associated anaplastic large cell lymphoma (BIA ALCL). BIA ALCL is not a breast cancer but a cancer of the immune system. Plastic surgeons have identified at least 688 cases of BIA ALCL worldwide, as of February 2019. The FDA estimates the risk of BIA ALCL among patients with textured implants as between 1 in 3,817 and 1 in 30,000, but newer data from Australia has placed the risk as high as 1 in 1,000.

While the vast majority of BIA ALCL cases occur in patients with textured implants, the FDA has identified at least 24 in patients with smooth-surfaced implants.

Breast Implants Can Cause Cancer

There is now a link between cancer and breast implants emerging in scientific and medical circles. Just recently in France, their National Cancer Institute released a study that found a “clearly established link” between Anaplastic large cell lymphoma (ALCL) and breast implants. French officials have now recommended that breast implants in their country must carry a “cancer warning.”

There is also more evidence to back this connection now that a study conducted by Cambridge University in the UK found that nearly all cases of ALCL were discovered in women who had breast implants.

When you think about how breast implants are inserted — indeed it is quite gory and gruesome surgery — and about the horrific chemicals they are comprised of, it makes sense that they would, of course, pose a cancer risk. And now we have the data to support this.

The primary makers of breast implants approved for use in the United States include:

Allergan, Inc.

Ideal Implant, Inc.

Mentor World Wide, LLC (Johnson & Johnson)

Sientra, Inc.

 

Melissa Shirley vs. Mentor Worldwide (J&J) Complaint USDC ND Georgia (May 15, 2017)

 Silicone Breast Implant Lawsuit Not Preempted, Case to Proceed USDC ND Illinois Ruling

As of July 6, 2019, the Food and Drug Administration (FDA) has received a total of 573 US and global medical device reports (MDRs) of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). This total includes all MDRs the FDA received with any mention of “ALCL” or other spelling variations (for example, “anaplastic lymphoma,” or “anaplastic”) in the event narrative. BIA-ALCL MDRs are counted for those reporting a diagnosis or treatment of ALCL, or confirmed pathology/cytology test, or Anaplastic Lymphoma Kinase (ALK) and CD30 biomarkers.

The tables below summarize unique BIA-ALCL MDR data from the U.S. and worldwide that the FDA has received as of July 6, 2019.

Table 1: Summary of US and Global Deaths Reported in MDRs Received as of July 6th, 2019 (N = 33)

https://www.fda.gov/medical-devices/breast-implants/medical-device-reports-breast-implant-associated-anaplastic-large-cell-lymphoma

These data are a tabulation of global deaths reported in MDRs and literature reported as MDRs submitted to the FDA.  We excluded apparent duplicates. The data is stratified by factors that we considered in our analysis.

ALCL Deaths from MDRs and Literature reported as MDRs* Deaths through 7/6/29 (n=33)
n %a
Age at time of diagnosis (years) Median 52
Range 37-83
Not specified (# of reports) 13 39
Time from the last implant to diagnosis (years) Median 9
Range 1-20
Not specified (# of reports) 23 70
Implant Surface Textured 15 48
Smooth* history of textured 1 3
Not specified 17 48
Implant Fill Silicone 14 42
Saline 8 24
Not specified 11 33
Reason for Implant Reconstruction 5 15
Augmentation 17 52
Not specified 11 33
Clinical presentation (breast)b Seroma 6 18
Breast swelling/pain 3 9
Capsular contracture 1 3
Peri-implant mass/lump 13 39
Others 7 21
Not specified 7 21
Anaplastic lymphoma kinase (ALK) Positive 0  0
Negative 12 36
Not specified 21 64
CD30 Statusc Positive 12 36
Negative 0 0
Not specified 21 64
Implant manufacturer Allergan 12 36
Mentor 1 3
Unknown 20 61
Reporter country: US or OUSd US 12 36
OUS 21 64
Not specified 0 0

a Percentage in terms of the total 33 deaths. There are no reports of deaths associated with tissue expanders.
b MDRs sometimes list more than one clinical presentation, e.g. seroma and peri-implant mass/lump, in which two presentations were counted.
c CD30 is a cell membrane protein associated with diagnosis of classic Hodgkin’s Lymphoma and BIA-ALCL.
d US/OUS is counted as the country reported in the narrative or the recorded reporter’s country in the MedWatch form.
* Includes 1 case of B-Cell Lymphoma

Table 2: Summary of US and Global Data as of July 6, 2019 (N=573)

These data are a tabulation of US and global BI-ALCL cases reported to the FDA in MDRs.  We excluded apparent duplicates.  The data is stratified by factors we considered in our analysis.

Unique ALCL cases1 Cases through 9/30/18
(n=457)
Cases through 7/6/19
(n=573)
n %a n %b
Age at time of diagnosis (years) Median 53 53
Range 27-90 27-90
Not specified (# of reports) 111 24 161 28
Time from the last implant to diagnosis (years) Median 9 8
Range 0-34 0-34
Not specified (# of reports) 110 24 169 29
Implant surface Textured 310 68 385 67
Smooth 24 5 26c 5
Not specified 123 27 162 28
Implant fill Silicone 274 60 343 60
Saline 183 40 197 34
Not specified 0 0 33 6
Reason for implant Reconstruction 108 24 115 20
Augmentation 104 23 111 19
Not specified 245 54 347 61
Clinical presentation (breast)d Seroma 266 58 302 53
Breast swelling/pain 135 30 150 26
Capsular contracture 69 15 73 13
Peri-implant mass/lump 82 18 94 16
Others 43 9 56 10
Not specified 105 23 147 26
Anaplastic lymphoma kinase (ALK) Positive 0  0 0 0
Negative 229 50 255 45
Not specified 228 50 318 55
CD30 statuse Positive 215 47 246 43
Negative 0  0 0 0
Not specified 242 53 327 57
Implant manufacturer Allergan* includes McGhan, Inamed 386 84 481 84
Mentor 36 8 38 7
Sientra 2 0.4 6 1
Other Manufacturerf 5 1 6 1
Unknown Manufacturer 28 6 42 7
Reporter country: US or OUSg US 276 48 320 56
OUS 181 32 253 44
Not specified 0 0 0 0

1Patients with bilateral BIA-ALCL are counted as 2 cases of BIA-ALCL.
a Percentage in terms of the total 457 MDRs.
b Percentage in terms of the total 573 MDRs.
c In the 26 cases of smooth implants, 12 have unknown prior history of implants, 7 have a history of textured implants, and 7 have a history of prior implants with an unknown texture. There are no reports of cases associated with tissue expanders.
d MDRs sometimes list more than one clinical presentation, e.g., seroma and peri-implant mass/lump, in which two presentations were counted.
e CD30 is a cell membrane protein associated with diagnosis of classic Hodgkin’s Lymphoma and BIA-ALCL.
f Other Manufacturers include: Bristol Myers Squib, Nagor, Polytech Silimed, Silimed and Sientra/Silimed
g US/OUS is counted as the recorded reporter’s country in the MedWatch form, or if the event was noted to be from a foreign source in box G3 of the MedWatch form. Please note that the reporter country may not reflect the country where the event occurred or the country where the device is marketed.

History of Adverse Events Has Been Known 

The FDA has  coordinated with the American Society of Plastic Surgeons and the Plastic Surgeons Foundation to develop the Patient Registry and Outcomes for Breast Implants and Anaplastic Large Cell Lymphoma (BIA-ALCL) Etiology and Epidemiology (PROFILE), which collects real world data regarding patients who have a confirmed diagnosis of BIA-ALCL. The data collected from this registry, have contributed to a better understanding of BIA-ALCL and FDA communication updates to the public regarding BIA-ALCL.

According to a complex analysis of FDA adverse event data, the number of suspected breast implant injuries jumped from an average of fewer than 200 a year through 2016, before the FDA’s more rigorous reporting rules, to 4,567 events in 2017 and at least 8,242 in the first half of 2018. More than 10 million women worldwide have received breast implants over the last decade, a remarkable comeback for a medical product that had suffered a crippling safety scandal and a lengthy ban in the United States.

The agency was aware of the true number of reported injuries but did not disclose them until recently. In Europe, some manufacturers have avoided reporting ruptures altogether, Dutch regulators were told. This was discovered during the  International Consortium of Investigative Journalists long term investigation titled, Implant Files investigation , which revealed the ongoing health problems plaguing many thousands of women with breast implants as part of its global research project that was released in November 2018.

Experts worldwide agree that more long-term studies are desperately needed, but neither Allergan nor Johnson & Johnson’s Mentor completed the studies of 40,000 women ordered by the FDA.  After two years, about 40 percent of the participants in the breast augmentation section of the Allergan study had dropped out; after three years, Mentor had lost about 80 percent of its breast augmentation study subjects.

The FDA now says that although it does not have evidence to support a link between breast implants and systemic illness, safety studies “would need to be much larger and longer than those conducted so far” to clearly rule out an association. Allergan and Mentor faced no consequences for failing to complete the mandatory studies.

In September 2018, researchers at the MD Anderson Cancer Center in Houston reported the results of the largest-ever long-term safety study of breast implants. The study found associations between silicone implants and three autoimmune diseases. In the same month, an Israeli study of tens of thousands of women also discovered a link between breast implants and autoimmune diseases. Several smaller studies conducted in recent years in the Netherlands and the U.S., reached similar conclusions.

In March 2017, the FDA issued a breast implant cancer warning, indicating that it was aware of at least 359 medical device reports involving women diagnosed with a rare form of non-Hodgkins lymphoma, known as breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). The illness has been linked to at least nine deaths.

The agency indicated at the time that the lymphoma cases appeared to be more common among breast implants with textured surfaces, as opposed to smooth breast implants, but a definitive connection was not able to be made.

Australia’s Therapeutic Goods Administration (TGA) launched an effort monitor the association between breast implants and anaplastic large cell lymphoma, more than doubling the recognized number of cases identified among Australian patients between September 2016 and April 2017.

Researchers from the TGA published a study in May indicating that side effects of textured breast implants may be linked to a 14 times higher risk of ALCL in some cases.

The TGA has estimated that the breast implant lymphoma risk may be between 1-in-1,000 and 1-in-10,000, with most cases occurring between 3 and 14 years after implant, but the median being 8 years and some cases diagnosed as much as 37 years after breast surgery,

Due to the potential lymphoma risk with breast implants, regulators have made efforts to increase awareness among health care providers about cases of the rare cancer linked to textured breast implants, indicating that they should discuss the benefits and side effects of the implants with their patients.

The FDA has also recommended that doctors consider the possibility that a breast implant recipient is suffering from anaplastic large cell lymphoma (ALCL) when they present with late, onset, persistent peri-implant seroma.

Each year in the United States more than 300,000 women and undergo breast augmentation, with the total number of breast implants procedures each year being  anywhere between 5 to 10 million around the world.

Before the operations women are often told by their surgeons that it is a safe procedure with “very little” risk, with the . FDA generally supporting that incorrect statement, by offering that “breast implants are relatively safe” which is now being shown to be very inaccurate.

There is a growing body of evidence, now supported by  thousands of examples of adverse events from women all over the world who have had implants. Facts are emerging that breast implants have been and continue to cause  debilitating autoimmune disorders  as well as emerging evidence of links to certain types of cancer.

No implant on the market today can last a lifetime. Every type is prone to leaking and rupturing, and instance, the saline valve implants, can even become black with mold, causing a systemic fungal problem in a person’s body.

Breast implant lawsuits are underway as of October 2016. In March 2017, the FDA issued a warning confirming that breast implants cause ALCL cancer. Lawsuits for ladies with BIA-ALCL are currently being organized. In April 2017, a bipartisan bill called the Medical Device Safety Act H.R. 2164 was introduced and needs your help in being passed to hold the manufacturers accountable for the harm they have caused. In January 2018, a Mentor MemoryGel Silicone Breast Implant case was able to in part pass preemption.

Background:

In the early 2000s, Allergan and Mentor were approved for premarket Investigational Device Exempt (IDE) studies where a limited number of plastic surgeons were allowed to use silicone breast implants, accordingly they were supposed to inform women of the study and follow up on them. In November 2006, Mentor and Allergan silicone breast implants were conditionally approved and six postmarket studies were to be conducted, see Mentor Approval Order and Allergan (formerly Inamed) Approval Order. The manufacturer premarket and postmarket studies have overall failed to follow up on women and provide real statistics on health problems that arise.

Presently, in 2018, there are over 50,000 women in breast implant illness Facebook support groups. Similar to the Dow times, the manufacturers have again pushed a campaign marketing the safety and inertness of implants rather than disclosing the truth of lack of real statistics and follow ups, the adjuvant immunologic effects of silicone, and the numerous heavy metals and chemicals used in manufacturing. With the lack of awareness on the matter, there is currently a public health crisis as the medical community at large has failed to help women identify breast implants as playing a role in their symptoms and has led to many misdiagnoses, unnecessary medications and treatments, and body parts being removed (thyroid, gall bladder, uterus, etc.). History is repeating itself and the manufacturers need to be held accountable for the alleged lack of informed consent and toxicity caused by saline and silicone breast implants.

Current Breast Implant Lawsuits:

Silicone

  • Weber v. Allergan (2012)
  • Ebrahimi v. Mentor (2016)
  • Mize v. Mentor Nguyen v. Mentor (Spouse Plaintiff) (2017)
  • Gravitt v. Mentor Gravitt v. Mentor (Spouse Plaintiff) (2017)
  • Skelton v. Allergan – BIA-ALCL (2018)
  • Cashen v. Mentor | Cashen v. Mentor (Spouse Plaintiff) – BIA-ALCL (2018)
  • Rea v. Allergan – BIA-ALCL (2018)
  • Vieira et al v. Mentor Worldwide, LLC et al (2018)
  • Sewell et al v. Mentor (2018)

Saline

  • Laux v. Mentor (2015)
  • Allergan Saline Lawsuits (2016)

Mentor Silicone Breast Implant Lawsuits:

Lawsuit Filed Against Mentor Worldwide Over Mentor MemoryGel Silicone Breast Implants 

(September 28, 2016)

A Seattle woman, Sara Ebrahimi, has filed suit against Mentor Worldwide LLC and its parent company, Johnson & Johnson Services, Inc., alleging the defective manufacturing of Mentor MemoryGel™ Silicone Breast Implants. The lawsuit alleges that Mentor and its parent company, Johnson & Johnson, repeatedly failed to follow the requirements imposed by the Food and Drug Administration (“FDA”) in connection with the approval of Mentor’s premarket approval application. It is further alleged that the companies failed to warn the FDA and women receiving the implants of the devices’ known dangerous propensities. The lawsuit — Ebrahimi v. Mentor Worldwide LLC, et al. (case no. 2:16-cv-07316-DMG) — was filed in the Central District of California in Los Angeles, where Mentor is headquartered.

Mentor develops, manufactures, and markets products for surgical and non-surgical procedures, including Mentor MemoryGel™ Silicone Breast ImplantsThe lawsuit alleges that chemicals Mentor used in the manufacturing process bled through the implants, and into Ms. Ebrahimi’s body, causing her to suffer serious medical problems. It is alleged that Mentor and Johnson & Johnson knew that their devices were defective, yet allowed them to be surgically implanted in Ms. Ebrahimi and other unsuspecting women. It is further alleged that Mentor and Johnson & Johnson failed to warn the FDA of these risks by not providing adequate follow-through studies.

Mentor MemoryGel™ Silicone Breast Implants are regulated medical devices under the Food, Drug and Cosmetic Act that require FDA approval. As a condition of approval, the FDA required that Mentor conduct six post-approval studies to demonstrate, over time, that its silicone implants were safe and effective. The lawsuit alleges that Mentor failed to design effective studies and, as a result, failed to provide the FDA with the longitudinal studies that were required as a condition to the devices’ approval. It is alleged that:

It was Mentor’s obligation to design and execute a study where women were able to access internet forms that are easily understood and provide a working forum to report their experience with implants. Mentor intentionally and systematically failed to make this happen which is a violation of the FDA’s conditions for approval. Data collection was sparse and potential serious side effects and harmful complications were downplayed and under-reported due to inadequate sample size.

This lawsuit influenced a new wave of breast implant litigation. Its research and structure are being used as a model being replicated by the following lawsuits below.

Rexina Mize, et al. v. Mentor Worldwide LLC

(February 2nd, 2017)

The case is Mize v. Mentor Worldwide LLC, No. BC-649083, California Superior Court (Los Angeles). In March 2017, the case was transferred and reassigned to the federal judge handling Ebrahimi v. Mentor and the case number was changed to CV 17-1747 DMG (KSx). In August 2017, the case was remanded back to state court.

Her husband, Spouse Plaintiff Minh Nguyen, is also suing Mentor on loss of consortium.

From the article, Johnson & Johnson Unit Sued Over Leaking Breast Implants:

Catherine Gravitt, et al. v. Mentor Worldwide LLC

(July 25th, 2017)

The case is Gravitt et al v. Mentor Worldwide LLC, No. 1:2017cv05428, Illinois Northern District Court (Chicago). Catherine Gravitt and her husband Travis Gravitt are the plaintiffs who filed against Mentor, see Complaint. She was implanted with textured Mentor MemoryGel Silicone Breast Implants in 2010 and in 2016 she discovered a rupture. Health complications included abnormal thyroid levels, swollen lymph nodes, severe and random skin rashes, blackouts and periods of disorientation, extreme fatigue and weakness, muscle soreness, frequent flu like symptoms, anxiety, depression, and more. Additionally it is alleged she gave birth to a son and daughter who both developed defects related to the toxic materials leaking from her breast implants. See the docket and the news article, “Couple’s lawsuit faults California breast implant maker.

In January 2018, U.S. District Judge Gary Feinerman allowed the case to in part pass federal preemption, see Memorandum Opinion and Order. This is a significant court ruling for all breast implant cases. See the news article, “Mentor Silicone Breast Implant Lawsuit Not Preempted, Cleared To Proceed: Judge.”

Renee Cashen, et. al v. Mentor Worldwide LLC, Ethicon, and Johnson & Johnson 

(April 27th, 2018)

The case is Cashen et al v. Mentor Worldwide LLC, filed in the Superior Court of New Jersey. Renee Cashen and her husband Richard Cashen are plaintiffs. In February 2008, she was implanted with textured Mentor MemoryGel Siltex Round Moderate Gel Breast Implants. After implantation, she was discharged from the post-market study she had been enrolled in. In 2016, she noticed a lump under her right armpit. A month later a biopsy was done and ALCL was discovered but it took several weeks later until her doctors associated it with her Mentor breast implants. In May 2016, Mrs. Cashen had explant surgery and six lymph nodes removed. In July 2017, she began chemotherapy treatments. The Defendants allegedly failed to comply with their post-approval surveillance obligation.

They are represented by Ross Feller Casey, LLP and McEldrew Young, both in Philadelphia, Pennsylvania.

Vieira et al v. Mentor Worldwide, LLC et al

(June 27th, 2018)

Nicole Vieira and Emilia Barozzi filed complaints in Los Angeles County Superior Court, Case No. BC711663. Plaintiffs were implanted with Mentor MemoryGel Silicone Breast Implants and afterwards they “experienced various medical complications, including fatigue, weakness, memory loss, and nausea.” After explantation it was discovered that the implants’ silicone gel had bled. The complaint alleges mistakes in Mentor’s manufacturing of the implants and defects in the silicone used. These resulted in silicone gel to bleed and therefore triggered the medical complications.

In July the case was moved to Federal Court, Case No. 2:18-cv-06502, and in September it was remanded back to Los Angeles Superior Court.

Allergan Silicone Breast Implant Lawsuits:

Nicole Weber v. Allergan No. 13-17017 (9th Circuit 2015)

The case was filed in 2012 and is moving to trial in early 2018.

“Weber appealed the district court’s dismissal of Weber’s diversity action brought against Allergan Inc, asserting strict product liability and negligence, and alleging that Allergan’s Natrelle Style 20 [silicone] breast implants are dangerous.” (Sept 21, 2015). See youtube video on her 9th Circuit court hearing. (The opposing attorney talks at 37:00)

Her amended claim was found to adequately state parallel state law claims (Oct. 23, 2015).

“Weber has identified to the extent possible without discovery, the standards she believes the manufacture of her implants violated, adequately stating parallel state-law claims.” the court said.

Vivian Skelton v. Allergan – BIA-ALCL

The case was filed as Skelton v. Allergan, No. BC696400 in Los Angeles County Superior Court. It was transferred to California Central District Court and the case number was changed to 2:18-cv-02617. She was diagnosed with breast implant-associated anaplastic large cell lymphoma, this is an Allergan BIA-ALCL Lawsuit.

Rhea v. Allergan – BIA-ALCL

(May 8th, 2018)

Michele Rea and Carl Rea from Fairfax, Virginia filed in the Superior Court of New Jersey in May 2018, see case here.

From Ross Feller Casey in ‘Another Lawsuit Alleges Breast Implants Cause A Rare Cancer‘:

Rea underwent reconstructive surgery for a partial mastectomy in 2011. About five years later, she was diagnosed with anaplastic large cell lymphoma, which was caused by a Natrelle Style 410 [highly cohesive silicone gel] implant made by Allergan, Inc., the suit alleges.

Allergan Saline Lawsuits:

In Jacksonville, Florida, the law firm of Terrell Hogan is filing hundreds of lawsuits against two local plastic surgeons – Dr. Loren Clayman and Dr. Mark Clayman. There are also allegations of fraud, as well as a lawsuit against Allergan.

“I represent about 150 women,” said Attorney Chris Shakib.

Shakib, the lead attorney in the case, called his findings unbelievable.

For further information, see articles on this here (June 1st, 2016) and here (November 29th, 2016).

Mentor Saline Lawsuits:

Anita Laux v. Mentor Worldwide LLC

(December 29, 2015)

The case is Laux v. Mentor Worldwide LLC, No. 2:16-cv-01026-ODW(AGR), filed in Ventura County Superior Court and moved to federal court. She is represented by Robert A. Zeman (Law Offices of Robert A. Zeman) and Alan C. Milstein (Sherman Silverstein Kohl Rose and Podolsky).

Breast implants are categorized as Class III medical devices (along with hip implants, pacemakers, cardiac stents, etc) and are very difficult to sue due to the 2008 Supreme Court case, Riegel v Medtronic which gave broad federal protection to manufacturers. To sue a manufacturer, one would need a product liability case and these are generally governed by state laws under theories of negligence, strict liability, and breach of warranty. The Supreme Court ruling with Riegel created a precedent for preemption of state laws, essentially citing that Class III medical devices are solely accountable to the regulations and surveillance of the FDA. After Riegel, the only way to sue is to assert parallel state law claims where one must prove the manufacturer deviated from a guideline they were approved by (a violation of a federal requirement, such as a FDA guideline), the violation of an identical state law, and how that violation of that federal requirement caused injury.

BIA-ALCL

Breast implant associated anaplastic large cell lymphoma (BIA-ALCL) is a cancer of the immune system caused by breast implants. It is generally found in fluid collection in between the implant and capsule, in a seroma, or in a nodule in the capsule. Physical signs are effusion, swelling, pain, inflammation, mass, ulceration, and others. The overwhelming symptoms in a majority of patients is a delayed seroma, persistent swelling, and pain. While even more rare some patients may present skin changes, lymphadenopathy, capsular contracture, or a potentially palpable mass.1 CD30 is the diagnostic test being used to distinguish ALCL. It is found to occur at a much higher rate in textured breast implants, however there have been some smooth surfaced breast implant cases as well.

Risks:

“[S]tudies reported in medical literature estimate that the lifetime risk of developing BIA-ALCL for patients with textured breast implants ranges from 1 in 3,817 to 1 in 30,000.” – FDA Update 3/21/18

Medical Device Reports (FDA)

Update: As of July 2017, Dr. Mark Clemens states that worldwide there have been 464 adverse event reports in relation to BIA-ALCL and 12 deaths. See PSEN Breast Implant Associated Anapestic Large Cell Lymphoma.

As of February 2017, the FDA has received a total of 359 medical device reports (MDRs) of breast-implant-associated ALCL, including nine deaths. Out of those 359 total reports, only 64% (231 reports) listed data on the surface at the time of reporting:

  • 87% (203 out of the 231 report) were with textured surfaces
  • 12% (28 out of the 231 reports) were with smooth surfaces

Although it is rare, breast-implant-associated ALCL appears to develop more frequently in women with textured implants than in women with smooth-surfaced implants.

Sample of the FDA Adverse Event Reports on BIA-ALCL:

Note: Parentheses represent redacted information to protect privacy.

  1. Company rep reported right side anaplastic large-cell lymphoma and “subcutaneous nodules and lymph nodes. ” the pt had a bilateral reconstruction seven years ago with style 410 breast implant placed on the left side and a style 115 placed on the right side. The pt had done well until she presented last week with a pathology report from her oncologist stating that she had alcl. The pt stated that she had nodules on the right axilla. A pet scan was carried out that showed metastasis in the lung and bone marrow involvement. No seroma was noted. The oncologist has decided on her treatment plan to exclude radiation. Explant surgery will take place (b)(6) 2013. (Reported in 2013, Allergan silicone) Link.
  2. Anaplastic large cell lymphoma of the breast arising around mammary implant capsule: an (b)(6) report written in aesthetic plastic surgery 2013 reports alcl, seroma, pain. Additional information noted in article anaplastic large cell lymphoma of the breast arising around mammary implant capsule: an italian report written in aesthetic plastic surgery 2013 article notes in regards to the right side, “necrosis and chronic inflammation signs are present” and “skin above the implant became red and painful and the patient had febrile episodes. ” treatment noted for the event of seroma as “a broad-spectrum antibiotic. ” (Reported in 2013, Allergan silicone) Link.
  3. Healthcare professional reports a case of lymphoma and other b-symptoms via mw (b)(4) the mw notes that: “the reporter called on behalf of a pt who was diagnosed with alcl. The pt presented with anaplastic large cell lymphoma, diagnosed in 2013. History of hodgkin’s lymphoma diagnosed in 2011. These two events came about after the pt underwent breast augmentation in 1994. In 2010, pt presented with an abnormal mammogram performed in 2010. Breast pain, skin color change, skin texture change, and inflowing diffusion form the right breast up to right neck and shoulder. The pt was running a fever throughout the entire process. After an mri and subsequent test, the pt was diagnosed with hodgkin’s lymphoma and underwent mantle radiation. In 2012, the pt underwent surgery essentially for a breast mass, but the pt also desired a mastectomy for removal of right and left implants and capsules. The pathology of the operation soon reported that the pt also has alcl; the mass had come from the lymphoma. ” (Reported in 2013, Allergan saline) Link.
  4. Pt is a female who underwent left mastectomy in 1996, for ductal carcinoma in situ with tissue expanders and saline implant reconstruction. She presented in 2010, with a peri-implant hematoma, though possibly post-traumatic. She underwent evacuation of the hematoma and change to a silicone gel implant. All pathology specimens were negative for tumor. She again presented in 2012, with a spontaneous hematoma and at surgery multiple biopsies revealed anaplastic large cell lymphoma (alcl) limited to the periprosthetic capsule and hematoma fluid. After an extensive hematologic and metastatic workup which was negative, she underwent removal of the implant and total periprosthetic capsulectomy. Capsular pathology showed alcl. (Reported in 2012, Mentor silicone) Link.
  5. On (b)(6) 2010, diagnosed with anaplastic large cell lymphoma (alcl) alk-negative. Possibly related or caused by breast implants received in (b)(6) 2002 for augmentation. Experienced complications with left implant diagnosed as capsular contraction. Implant replaced on (b)(6) 2008. Still experiencing capsular contraction after replacement. (b)(6) 2010 – (b)(6) 2011: received 12 doses of chemotherapy, received 20 doses of radiation therapy. Preparing for stem cell transplant scheduled for (b)(6) 2011. (b)(6) 2010: needle biopsy – diagnosis lymphoma. (b)(6) 2010: surgical biopsy – diagnosis alcl. (b)(6) 2010: surgical biopsy – diagnosis alcl. (Reported in 2011, Allergan saline) Link.
  6. The original purchase date of this device was (b)(6)2004. In (b)(6) 2006, the pt was implanted with mentor siltex saline devices during a revision augmentation procedure. In (b)(6) 2008, the devices were replaced with mentor smooth saline devices due to a left device deflation. In (b)(6) 2010, the pt had both implants removed due to recurring fluid accumulation in the right breast. On (b)(6)2010, the pt was diagnosed with alcl (t-cell lymphoma). No further info is available at this time. (Reported in 2010, Mentor saline) Link.
  7. It was reported by a physician that a (b)(6) year old female patient was diagnosed with alcl on (b)(6) 2017. This patient’s medical history includes diagnosis of left breast invasive ductal carcinoma in (b)(6) 2015. She underwent bilateral mastectomy and bilateral tissue expander placement in (b)(6) 2015. The patient had mentor tissue expanders that were implanted from (b)(6) 2015. The patient then had mentor memory shape low high moderate plus profile breast implants (catalog #334-1507, r. Side serial # (b)(4)) implanted in (b)(6) 2015. On (b)(6) 2017, the patient experienced a large right breast effusion that developed over 24-48 hours. The effusion was aspirated and tested using flow cytometry and cd30 ihc and came back positive for bia-alcl on (b)(6) 2017. The time between patient signs/symptoms of peri-implant alcl to definitive diagnosis was 1 week. The patient did not have any complications such as infection, hematoma, or implant rotation during implant course prior to alcl diagnosis. The patient did not experience skin lesions, fevers, night sweats or weight loss. There was no pain, redness, palpable breast mass, or capsular contracture. The lymphoma cells were found in the seroma fluid surrounding the implant. Immunohistochemical and flow cytometry testing showed alk negative and cd30 positive results. This is a pathologically confirmed stage ie primary diagnosis of alcl. Based on histology, there is no capsular involvement. The lymphoma cells were found in the effusion fluid surrounding the implant. The patient underwent bilateral implant removal and capsulectomies with no implant replacement on (b)(6) 2017. The implants were intact and not ruptured upon removal. (Reported in 2017, Mentor Memory Shape Silicone) Link.

Above is only a sample of six reports to the FDA. As of July 2017, Dr. Mark Clemens states the FDA has received 464 adverse event reports in relation to BIA-ALCL and 12 deaths. Join the Facebook group ALCL in Women with Breast Implants BIA-ALCL to view reports by country.

BIA-ALCL Causation Theories:

The cause is still unknown but is actively being studied. Some researchers have theorized that biofilm contributes to lymphoma and others have thought the chemicals in the implants irritate the immune system. Both theories rely on the presence of persistent inflammation, which means chronic activation of immune cells and particularly the T lymphocytes, which are white blood cells involved with ALCL.

Throughout the body, there are many diverse populations of bacteria that are both beneficial and harmful. In recent years, there has been an increased focus in characterizing bacteria and analyzing patterns of bacteria to understand the possible correlation between normal versus infectious/cancerous scenarios – especially in relation to breast cancer. What has been discovered is that similar to how the gut has its own microbiome of good and bad bacteria, the normal breast tissue and human milk also have their own microbiology that over time is influenced by factors such as dietary and sugar changes. The article “Microbiota of the Human Breast Tissue” delves into the various specific bacteria that were found in human breasts. Since breasts are not sterile, if a foreign object is placed inside the body, it will be colonized and infected.

Biofilm is bacteria that adheres to the surfaces of medical devices. It can result in a low grade chronic bacterial infection, chronic inflammation, and capsular contracture. Some bacteria produce acid as they grow and this reduces the pH of the surrounding environment. In the closed off space between the surface of the implant and the inner capsule surface, the bacteria coating the implant could form an acidic environment that contributes potentially to the breakdown of silicone. Australian researchers found that biofilm from capsular contracture cases was different from the biofilm identified on 26 implants from lymphoma patients. This brings biolfim to light as “a possible infectious contributing cause” for the lymphoma.

The chemicals used in the manufacturing process, which are neurotoxic and carcinogenic, are also believed to be playing a role in the development of lymphoma. The majority of ALCL cases have been found with textured implants, the roughness of the surface is triggering chronic inflammation. Textured implants were designed to keep the implants in place, thus, the capsules embed themselves on and around the textured surface. This creates an intimate, hand in hand connection between the scar tissue and chemically abrasive textured surface. Over time, this can lead to a direct abrasive irritation of the immune system, significantly affecting T cells.

It is interesting to note the connection between polyurethane coated implants and textured implants. Polyurethane coated implants were the first type of breast implant linked to cancer, and textured implants have now become the second type of breast implant linked to cancer – what they both have in common is a chemically abrasive fuzzy surface. Polyurethane implants were in production from about 1980 to when the manufacturer voluntarily withdrew them in 1991 due to significant safety concerns. These implants were the precursors to the textured breast implants since the textured surface was thought to be important in reducing capsular contracture and firmness, but the implant manufacturers could not use polyurethane so instead they created the textured surface currently manufactured today (since the mid-1990’s). This textured surface is also linked to an increased occurrence of forming double capsules (scar tissue surrounding the implants) and seromas, thereby going against its intended purpose.1,2

Protocol: 

In October 2017, a study published in the medical journal JAMA Surgery warned that many breast implant cancer case worldwide were probably not reported, and noted that doctors and patients may not be aware the ACCL risks. As more information becomes public about the breast implant cancer cases, experts have warned that the number of cases reported will likely increase significantly.

BIA-ALCL and Mammograms:

There have been cases reported in the BIA-ALCL FB Support Group where mammograms have triggered breast swelling and led to BIA-ALCL diagnoses.

Resources:

Government Health Agencies and Other Sources

Science and Medical: 

Please see the Scientific Articles page for over 200+ references to breast implant related scientific articles. They are organized into eight categories: 1. General, 2. Researchers, 3. Saline Implants & Mold, 4. Ruptured Silicone Implants, 5. Biofilm & Infections, 6. Breast Feeding with Implants and Effects on Children, 7. Biomaterials, and 8. ALCL (cancer).

Current Experts:

Dr. Pierre Blais (chemist and biocompatibility expert – Canada), Dr. Arthur Brawer (rheumatologist and silicone toxicity expert – Long Branch, NJ), Dr. Yehuda Shoenfeld (physician and autoimmunity researcher – Israel), Dr. Cohen Tervaert (rheumatologist – Edmonton, Canada), Dr. Henry Dijkman (pathologist – Netherlands), Dr. Diana Zuckerman (President of National Center of Health Research), Dr. Sarah Myhill (UK), Dr. Lu-Jean Feng (plastic surgeon – Cleveland, OH), Dr. Victor Urzola (plastic surgeon – Costa Rica), Dr. H. Jae Chun (plastic surgeon – Newport Beach, CA), Dr. Matthew G. Stanwix (plastic surgeon – Henrico, VA), Dr. Susan Kolb (plastic surgeon – Atlanta, GA), Dr. Edward Melmed (plastic surgeon – Dallas, TX), Dr. Rita Kappel (plastic surgeon – Netherlands), Dr. Michael Harbut (environmental medicine specialist – Detroit, MI), Dr. S V Maharaj (silicone breast implants and platinum expert). See here for some of their publications.

Educational Links:

What You Need to Know About Breast Implants (National Center For Health Research)

Breast Implant Illnesses: What’s the Evidence? (National Center For Health Research)

Safety – Junk Science, ‘New’ Cohesive Gel, and Toxicity for Silicone and Saline Implants

Breast Implants and Cancer (BIA-ALCL) and BIAALCL.com

Dr. Myhill –

Silicone Breast Implants and Injections

Chemical Poisoning – Diagnosis

Detoxification

Dr. Urzola –

Breast Implant Illness

“Over the past year and 8 months I have learned and researched a lot about this condition. After explanting over 100 patients and seeing the extraordinary post operative reports with over 85% of patients reporting complete remission of their symptoms or at least an important improvement, we are committed to starting a scientific investigation with the purpose of validating BII as a syndrome and getting the medical community to recognize it as a problem affecting thousands of women around the world.” (2017)

Dr. Feng –

Breast Implant Removal: Basics I

Topic: Linda L. Haas, Feng Clinic CEO, answers basic scheduling questions from patients who have just started researching breast implant removal. Videos: Part I and Part II.

Breast Implant Removal: Basics II

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Note: (Excerpts within this article include other online media sources)

____________________________________________________________________________

Additional Resources On Breast Implant Complications and Adverse Events

Topics: pathology, mold/microorganisms, detoxification, coinfections/diseases, selecting a surgeon, silicone vs. saline, capsule removal, lymph node removal, hormones and symptoms of BII. Videoand Transcript.

Breast Implant Removal: Basics III

Topics: the aesthetics of the breast, muscle repair, mastopexies or breast lifts, fat transfer and who is a candidate. Video and Transcript.

Breast Implant Removal IV: Detoxification

Topic: An in-depth discussion of detoxification before and after breast implant removal. Video.

Will I recover from breast implant illness without lymph node removal? (Video)

Is There A Connection Between Lyme Disease and Breast Implant Illness? (Video)

MTHFR and breast implants (Video)

Dr. Feng Webinars I-IV and YouTube Channel

Research articles and studies

Dr. Chun –

“Many patients suffer from BII(Breast Implant Illness) from their saline or silicone breast implants.” – Dr. Chun’s Breast Implant Removal Page

YouTube Channel – with videos on explantation, ruptured implants, difficulty associated with detecting ruptured silicone, and an en bloc capsulectomy explant (graphic).

Instagram where you can see Dr. Chun’s meticulous skill and expertise in doing perfect en bloc explants.

FDA Testimony

Dr. Kolb –

If something is of use to women affected by breast implant illness, it will be provided on this website regardless of politics.

Doctors, are you listening?

Immune Protocol

Silicone Immune Treatment Protocol

Inositol for Silicone Detoxification Provided by Dr. Douglas Shanklin

Videos: Dr. Susan Kolb discusses silicone breast implants and saline breast implants

Book: The Naked Truth About Breast Implants: From Harm to Healing

Note: There are currently four pending medical malpractice lawsuits filed against this plastic surgeon.

Dr. Blais –

Breast Feeding

Truth on ‘Cohesive’ Gel Implant

Technology and composition of silicone breast implants

How do implants rupture and cause injury

Testimony to the FDA (2000) 

All articles on breast implants by Dr. Pierre Blais, click here. Topics include: rupture, cancer, breast feeding, polyurethane, saline implants, cohesive gel, explant problems etc.

Dr. Blais is a chemist and expert in the biocompatibility of implant materials. He has been analyzing breast implants and conducting breast implant failure analyses for over 40+ years. There is currently a backlog due to the high demand and he is not accepting any new breast implants. Dr. Blais is a significant resource, he is a wealth of information on most breast implant matters.

Dr. Brawer –

Case Report: Silicone is not fun in the sun (2018)

ASIA vs. the mechanisms of silicone toxicity (2017)

Vague Syndromes (2017)

Mechanisms of Breast Implant Toxicity (2017)

Autoinflammatory Syndrome Induced by Adjuvants (ASIA) Syndrome is Misguided (2017)

Destiny rides again: the reappearance of silicone gel-filled breast implant toxicity (2017)

Breast Implant Toxicity (2016)

Bones, Groans, and Silicone (2012)

Amelioration of Systemic Disease after Removal of Silicone Gel-filled Breast Implants (2000)

Silicon and matrix macromolecules: new research opportunities for old diseases from analysis of potential mechanisms of breast implant toxicity (1998)

Chronology of systemic disease development in 300 symptomatic recipients of silicone gel-filled breast implants (1996)

Clinical features of local breast phenomena in 300 symptomatic recipients of silicone gel-filled breast implants (1996)

Dr. Schoenfeld

Silicone breast implants and the risk of autoimmune/rheumatic disorders: a real-world analysis (2018)

The ASIA syndrome: basic concepts (2017)

Autoimmune/Inflammatory syndrome induced by adjuvants (ASIA) and thyroid autoimmunity (2017)

Sjörgen’s Syndrome and Environmental Factors (2016)

Silicone and Autoimmune/Inflammatory Syndrome Induced by Adjuvants (ASIA). (2015)

Silicone implant incompatibility syndrome (SIIS). A frequent cause of ASIA (Schoenfeld’s syndrome). (2013)

Autoimmune/inflammatory syndrome induced by adjuvants (Shoenfeld’s syndrome): clinical and immunological spectrum (2013)

The spectrum of ASIA: ‘Autoimmune (Auto-inflammatory) Syndrome induced by Adjuvants’ (2012)

’ASIA’ – Autoimmune/inflammatory syndrome induced by adjuvants (2010)

Fibrosarcoma after silicone breast augmentation: is there a connection? (1998)

Light and electron microscopic study of an invasive cribriform carcinoma with extensive microcalcification developing in a breast with silicone augmentation (1994)

Breast carcinoma occurring in association with silicone augmentation (1993)

Doctors Speak Out –

Dr. Bernard PattenDr. Al LevinDr. Robert Goldwyn,

Dr. Frank Vasey (the “Dark” side of silicone breast implants)

Dr. Stephen Edelson (goes into symptom mechanisms)

Dr. Britta Ostermeyer (on dangers of silicone implants)

Other Educational Videos –

Breast Implant Illness – Dr. Faria

Integrative en-block treatment – Dr. Hovsepian

Capsular contracture – ruptured breast implants – Dr. Cassileth

Silicone Toxicity and Detoxification – Dr. Jennings

Immune Response to Silicone (skip to 5:38 for the effects on children)

Dr. Urzola’s Live Feed on Breast Implant Illness (2017)

Other links:

National Birth Defect Registry

  • Did you have breast implants while pregnant?
  • Did you breastfeed with breast implants?
  • Was your child born with a birth defect? Was your child born with a birth defect?

The National Birth Defect Registry might be able to help us research any possible link between breast implants and birth defects. If you’d like to help, please go to their website and register. Click here for more info.

***Search here if a doctor is receiving payments from a manufacturer and here (such as fees in research, consulting, speaker, sponsor, etc).

Petitions –

Breast Implant Petition

Request FDA Hearing

Medical Device Safety Act H.R. 2164

Surveys –

Dr. Victor Urzola’s Breast Implant Illness Data Collection Database

Dr. Yehuda Shoenfeld’s ASIA survey

PIP Implants Survey – if you have or had PIP, please fill out this survey

Concerns for estrogenicy of silicone breast implants

Allergan manufacturing patent

Method of making textured surface implants patent (Mentor)

UK MHRA PIP Implant Ingredient Analyses

Dr. Harbut response to FDA on platinum toxicity

Dr. Maharaj and Dr. Lykissa responses to FDA on platinum toxicity

Facebook Support Groups:

US: Breast Implant Illness – The Ticking Time Bomb

Breast Implant Illness and Breast Cancer Survivors Home

Canada: Breast Implant Failure and Illness – Canada

Australia: Breast Implant Illness – (Australia & New Zealand) Healing and Support

UK: UK Breast Implant Illness and Healing Support Group

ALCL: ALCL in Women with Breast Implants (BIA-ALCL)

For all medical devices: Medical Device Problems

Mothers: Breast Implants and Children

There are over 160+ breast implant illness support groups and awareness pages on Facebook where women share their experiences.

Personal Stories and Videos:

The Naked Truth // My Life with Breast Implants

Personal stories

Alex Chafen – Breast Implants, a Husband’s Perspective

Andrea Conti Cowder (Video and BII Story)

Pursuing Explantation – My path to health after breast implant illness

Beth Maturevich – Breast Implant Illness (Saline) Video

Raylene Hollrah – Diagnosed with ALCL, story

Implant Illness Awareness – Breast implants are not safe. We are the proof.

Mybreastimplantillness WordPress 

nothappywithmentor.blogspot.com

The faces of breast implant illness – Video

Jamee Cook –

Pursuing Explantation – My path to health after breast implant illness

YouTube channel on breast implant illness

Advocacy Groups:

US:

Canada:

Australia:

Netherlands:

UK:

Scotland:

Ireland FB Group: PIP Ireland

France:

Italy FB Page: Protesi PIP and Blog

Sweden:

Switzerland: Informationen zu Brustimplantaten

Venezuela FB Group: Protesis Mamarias PIP

Brasil: Breast Implants Illness (Doença Prótese Mamária) Brasil

Singapore FB Page: Implant Illness and Detox Singapore

South Africa: Breast Implant Illness – South Africa

Breast Implant Illness Websites:

Breast Implant Victim Advocacy (BIVA)

Breast Implant Failure

BIA-ALCL

BIA-ALCL Awareness –  Just Call Me Ray Foundation  (Non-Profit)

Breast Implant Info (Non-Profit)

No Grit No Pearls.org (Non-Profit)

Toxic Discovery (Non-Profit)

Life Since Explant Club

Reversing Breast Implant Illness

Healing Breast Implant Illness

Discover Breast Implant Illness

Miss Diagnosed

BII Aware

Prothese Mammaire Danger

Fake Breasts Real Women

Breast implant illness websites and forums have been around since the late 90s and early 2000s:

Silicone Poison Report

Silicone Holocaust

Implant Information Network (founded in 2004)

Breast Implant Awareness – Humantics Foundation (founded in 2001)

Silicone Implants Survivors (forum since around 1999) and PS List

Silicone Hypersensitivity (owner passed away)

In addition, there were Yahoo support groups and breastimplantsupport.org was another popular forum but now is no longer running.

Breast Implant Manufacturer FDA Information:

Recalls

Allergan Natrelle Silicone & Allergan Silicone Timeline 

Allergan Natrelle 410 Cohesive Anatomical Silicone & Allergan Silicone Timeline

Mentor MemoryGel Silicone & Mentor Silicone Timeline

Mentor MemoryShape Silicone & Mentor Silicone Timeline

Sientra Silicone & FDA Timeline

Allergan Natrelle Saline & Saline Timeline

Mentor Saline & Saline Timeline

Ideal Saline & Saline Timeline

For more information on breast implant FDA links and how to do more FDA research, click here.

Books:

The Naked Truth About Breast Implants: From Harm to Healing by Dr. Susan Kolb

The D.I.R.T. Committee by Gail Hamilton

  • Must read, especially if you had Dow
  • D.I.R.T = Document Investigation & Review Team

The Boobie Trap: Silicone, Scandals, and Survival by Barbara Stanistreet

Informed Consent by John A. Byrne

Dr. Andrew Hall Cutler:

Dr. Cutler has a PhD in chemistry from Princeton University and has extensive study in biochemistry and medicine. He himself got mercury poisoning from amalgam fillings and created these books to provide guidance for detoxification.

Movies: Two Small VoicesBreast Men, Absolutely Safe

Press Articles & News:

Crystal Hefner Removes Breast Implants, Says They ‘Slowly Poisoned’ Her

Mother feels she is dying after her 32E breast implants ‘poisoned’ her

Dr. Britta Ostermeyer testifies to FDA in 2000 on the dangers of silicone breast implants.

Safety of breast implants under review in South Korea after silicone gel found in breast milk

FDA panels put silicone breast implants back under microscope (2011)

The silicone implant scandal (2012)

Breast Implants: America’s Silent Epidemic

Breast Implant Illness by Maya

Sara-Jane Fitness Cover Story

The Troubled History of PIP’s Implant Man in America **Implant manufacturers all operate in relatively similar ways and this article provides a glimpse of the dirty and corrupt business.

The “Dark” Side of Silicone Breast Implants

Toxic Moldy Breast Implants

Breast Implant Toxicity – on the radio with Danielle Delaney & Alex Charfen

The Ill Effects of Breast Implants

Why are celebrities removing their breast implants?

Explant Breast Surgery: Why women are getting their breast implants removed

Devoted mother-of-four dies from heart failure after implants trigger dormant TB

46 cases of ALCL diagnosed in Australia & New Zealand

Australia’s health regulator has confirmed that women with breast implants have a much higher risk of cancer (7 News Sydney – Video)

Patients accuse breast implant manufacturer of fraud (2016 – Allergan)

Breast implant illness conference – Texas (7/16/16)

News Segment on a lady with breast implant illness & saline implants

Monsters Inside of Me – Discovery Channel on saline implants with mold

Mold and Breast Implant Illness – The Doctors (TV show)

2017 – Important Year for Breast Implant News –

Breast implant illness gains nationwide coverage and becomes a movement:

French court says German firm must compensate for faulty breast implants

Woman who beat breast cancer once says breast implants caused cancer again

Johnson & Johnson Unit Sued Over Leaking Breast Implants

Johnson & Johnson, Mentor Worldwide LLC Senior staff target Support Groups

Former Playboy Models Get Their Breast Implants Removed Believing They Caused Illness

Mother-of-two is left with ROTTING breasts after silicone implants leaked into her blood stream – as cosmetic procedures fall to a ten-year low in the UK 

Can implants kill you?

Phoenix Valley women speak out on breast implant illness: ‘I just had to get them out’

Doctor’s Breast Implant Illness Denial Elicits Strong Response

Breast Implants Cause Rare Form of Cancer, FDA says

9 deaths linked to rare cancer form breast implants

In the News: Breast Implants Linked to Rare Cancer (Diana Zuckerman)

Former Women’s IFBB Pro Jackie Paisley dies after long battle with illness (silicone toxicity)

Breast Implant Survey Suggests Doctors Divided on Safety

Nicola Robinson’s Deepest Regret (silicone breast implants)

Breast Implant Illness + 6 Other Breast Implant Dangers (Dr. Axe)

Playboy Models Claim Implants Caused Health Problems (The Doctors, show)

Former Playmate of the Year on removing breast implants: ‘I literally thought I was dying’ (AZ Family News)

Women complain that their breast implants made them sick (West Palm Beach – WPTV News)

Her Hidden Dangers (Illinois – 23WIFR News)

Breast implant patient’s life ‘could have been saved’ – Hairdresser Kandi du Cros died after breast implant operation flared up rare existing disease (BBC News)

2 Massachusetts Women, Thousands Nationwide Say Breast Implants Made Them Sick (CBS Boston News)

Women concerned about implants after learning they may be linked to rare cancer (Fox 59 Indianapolis News)

Caldwell woman diagnosed with cancer from her breast implants, insurance won’t pay to remove them (KIVI 6 On Your Side – ABC Idaho)

A Shocking Diagnosis: Breast Implants ‘Gave Me Cancer’ (NY Times)

DeLauro Statement on Breast Implants Connected to Lymphoma (United States Representative Rosa DeLauro)

Swedish breast implant illness news story: Johanna, 31, varnar andra: “Implantaten gjorde mig jättesjuk”

Danish: Johanna fik opereret brysterne større – aldrig har hun fortrudt noget så meget

Woman reveals danger of implants, horror of lawsuits – silicone poisoning brings on 20 year suit with Dow Chemicals (UB Media Biz)

Conflict of Interest: The FDA & Big Pharma – Does the FDA Work for Big Pharma? (Drug Watch)

Breast prostheses: For a national registry of complications (Dr. José Budo)

Colorado women claim breast implants made them sick (Denver 7 News)

Did breast implants make Valley woman sick? (ABC15 Arizona)

9 Investigates health concerns with silicone breast implants (WFTV9 Orlando, FL)

Brit Boob Implant Cancer Bombshell – Two breast surgery patients die from a ‘bombshell’ cancer linked to implants

Rare cancer reignites debate over breast implants’ safety

Silicone Breast Implants are back – This Time the Issue is Cancer

Sydney mother’s dire warning after breast implants almost ruined her life. (Australia News)

Dr. Robert Whitfield MD, FACS describes breast implant-related illness (The Plastic Surgery Channel)

The Explant Phenomenon (Huffington News)

Former ‘Playboy’ playmates have ‘toxic’ breast implants removed after they make them sick (Inside Edition)

Women say breast implants caused unexplained illness for years (WSB-TV Atlanta, GA)

Why scores of women are having their implants removed (Tucson News, AZ)

More Canadian women having their breast implants removed, surgeons say (CTV News)

2018

Women battling illness after breast implants urge awareness, education (CBS Miami)

The breast implants that may be linked to blood cancer: Linzy was baffled by her symptoms but doctors solved the mystery in time for her to make a full recovery (Daily Mail UK)

South Florida Woman: Breast implants ruined my life (West Palm Beach – WPTV News)

CBS 5 Investigates: Chemist claims breast implants make some women sick (CBS Arizona)

Why Kiwi women are getting their breast implants removed (New Zealand)

I spent the last five years managing my health so my body could cope with these toxic bags’: Why more women are having their breast implants REMOVED following debilitating complications (Daily Mail Australia)

Facing unexplainable symptoms, metro women argue silicone breast implants made them sick (Fox 4 Kansas)

Arkansas women want doctors, FDA to recognize seriousness of ‘Breast Implant Illness’ (THV11 Arkansas)

My breast implants were killing me – how I took my life back (Elephant Journal)

Calls to ban textured breast implants after two die and 23 develop same type of cancer (My Vue News – UK)

Kiwi woman says seven-year illness caused by breast implants (Stuff – New Zealand)

Perth mum Ricci Jess reveals painful truth behind fake boobs (Perth Now – Australia) 

Explants: breast implants removal surgery grows among Perth women (Perth Now – Australia)

My breast implants nearly destroyed my life: how S Club 7’s Hannah Spearritt was left in agony following the boob job she craved (Daily Mail UK)

After 17 years with breast implants, Princeton woman leads calls for more education, safety (WFAA 8 ABC – North Texas)

Mount Pleasant woman says breast implants caused serious health problems (4News – Mount Pleasant, South Carolina)

Breast Implant Illness: What we don’t know can hurt us (Swaay)

Glamour model who got a boob job at 18 shares her plastic surgery nightmare that destroyed her kidneys and has left her on dialysis (Daily Mail Australia)

Facing health issues, Georgia woman has breast implants removed (Fox5 – Atlanta, Georgia)

Breast Implant Illness: Two metro women say implants caused years of complications (13 WHOtv – Iowa)

Breast Implant Illness: Woman claims implants made her sick (7 WJHG – Panama City Beach, Florida)

Former local 4 reporter says breast implants caused years of chronic fatigue, depression, hair loss (Click On Detroit – Michigan)

Auckland woman ‘s painful lesson about the dangers of breast implants (News Hub – NZ) 

What this yoga teacher learned from her mistake with breast implants (Charlotte Five)

Biocell textured breast implants under scrutiny as women complain of pain (CBC – Canada)

Breast implants reveal problems in tracking device safety (AP News) 

Breast Implant Injuries Kept Hidden As New Health Threats Surface (ICIJ)

Under the skin of ICIJ’s Implant Files (ICIJ)

Breast implants study reveals serious safety concerns (The Guardian)

The Implant Files reveal how breast implants linked to rare cancer set off alarm bells (ABC – Australia)

The Implant Files: Faulty breast implants leave women in limbo (Financial Review – Australia) 

Bare dager etter at hun opererte inn silikon i brystet, merket Karin Wenke Osthaug at noe var galt (Aftenpolten – Norway)

Cancer lié aux prothèses mammaires (LAGC) : l’inertie des autorités sanitaires (France Culture)

Temor, burocracia y dolor: hablan tres argentinas damnificadas por implantes mamarios (Perfil – Argentina)

British women are hit by new breast implant cancer scare seven years after PIP scandal as concerns grow over most commonly-used implant banned in France but still allowed in UK (Daily Mail – UK)

Rare form of Blood Cancer Linked to Certain Type of Breast Implants Used by Thousands of Women (People)

Breast Implants May Increase Your Risk of A Rare Type Of Cancer (Women’s Health)

Some medical devices deemed unsafe in other nations still sold in U.S. (NBC News)

Breast-implant-related complications, including cancer, kept secret thanks to broken reporting system (The Star)

My Breast Implants Made Me Sick – and Nobody Believed Me (Cosmopolitan)

Hidden dangers: patients, doctors not informed of defective implants (ICIJ)

Many Women Getting Breast Implants Removed In Light Of Health Concerns (CBS Philly)

Mother, 34, who was left ‘slowly dying’ by her ‘toxic’ C-cup breast implants has them removed after four years of agony (Daily Mail and The Sun)

Richmond woman warns of breast implant illness (K12 – Virginia)

As the Allergan breast implants disaster explodes, isn’t it time women say enough is enough? (Huffington Post – UK)

Allergan’s textured breast implants recalled by French authorities (NBC News)

 

 

 

Read More

ALLERGAN BREAST IMPLANTS RECALLED WORLDWIDE TODAY JULY 24, 2019

“Textured implants linked to rare form of cancer per FDA”

By Mark A. York (July 24, 2019)

 

 

 

 

 

 

(MASS TORT NEXUS MEDIA) A worldwide recall of breast implants by Allergan Inc. was issued Wednesday for textured models because of a link to a rare form of cancer. The U.S. Food and Drug Administration said it called for the removal after new information showed Allergan’s Biocell breast implants with a textured surface account for a disproportionate share of rare lymphoma cases. The move follows similar action in France, Australia and Canada.

The FDA is not recommending women with the implants have them removed if they are not experiencing problems. The FDA had ruled earlier this year the implants could stay on the market.

The primary makers of breast implants approved for use in the United States include:

Allergan, Inc.

Ideal Implant, Inc.

Mentor World Wide, LLC

Sientra, Inc.

According to a complex analysis of FDA adverse event data, the number of suspected breast implant injuries jumped from an average of fewer than 200 a year through 2016, before the FDA’s more rigorous reporting rules, to 4,567 events in 2017 and at least 8,242 in the first half of 2018. More than 10 million women worldwide have received breast implants over the last decade, a remarkable comeback for a medical product that had suffered a crippling safety scandal and a lengthy ban in the United States.

The agency was aware of the true number of reported injuries but did not disclose them until recently. In Europe, some manufacturers have avoided reporting ruptures altogether, Dutch regulators were told. This was discovered during the  International Consortium of Investigative Journalists long term investigation titled, Implant Files investigation , which revealed the ongoing health problems plaguing many thousands of women with breast implants as part of its global research project that was released in November 2018.

https://www.cbsnews.com/news/breast-implant-recall-allergan-recalls-textured-implant-linked-to-rare-cancer-today-2019-07-24/

Nine deaths from a rare form of cancer have been linked to breast implants, the Food and Drug Administration announced in 2017.

In March 2017, the FDA issued a breast implant cancer warning, indicating that it was aware of at least 359 medical device reports involving women diagnosed with a rare form of non-Hodgkins lymphoma, known as breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). The illness has been linked to at least nine deaths.

The agency indicated at the time that the lymphoma cases appeared to be more common among breast implants with textured surfaces, as opposed to smooth breast implants, but a definitive connection was not able to be made.

Australia’s Therapeutic Goods Administration (TGA) launched an effort monitor the association between breast implants and anaplastic large cell lymphoma, more than doubling the recognized number of cases identified among Australian patients between September 2016 and April 2017.

Researchers from the TGA published a study in May indicating that side effects of textured breast implants may be linked to a 14 times higher risk of ALCL in some cases.

The TGA has estimated that the breast implant lymphoma risk may be between 1-in-1,000 and 1-in-10,000, with most cases occurring between 3 and 14 years after implant, but the median being 8 years and some cases diagnosed as much as 37 years after breast surgery,

Due to the potential lymphoma risk with breast implants, regulators have made efforts to increase awareness among health care providers about cases of the rare cancer linked to textured breast implants, indicating that they should discuss the benefits and side effects of the implants with their patients.

The FDA has also recommended that doctors consider the possibility that a breast implant recipient is suffering from anaplastic large cell lymphoma (ALCL) when they present with late, onset, persistent peri-implant seroma.

Biocell implants feature a textured surface designed to prevent slippage and to minimize scar tissue. Such models account for just 5 percent of the U.S. market. The vast majority of breast implants used in the U.S. have a smooth surface.

Health authorities first linked textured implants to cancer in 2011. The disease is not breast cancer but lymphoma that grows in the scar tissue surrounding the breasts. It grows slowly and can usually be successfully treated by surgically removing the implants.

As recently as May, the FDA said that the danger did not warrant a national ban on the devices. But the FDA said Wednesday that new data show a direct link to cancer with Allergan’s implants not seen with other textured implants.

“Once the evidence indicated that a specific manufacturer’s product appeared to be directly linked to significant patient harm, including death, the FDA took action,” said FDA deputy commissioner Amy Abernethy in a statement.

The FDA said the latest figures show more than 80 percent of the 570 confirmed cases of the lymphoma worldwide have been linked to Allergan implants. The updated figures reflect 116 new cases of the cancer since the FDA last released figures earlier this year.

The new numbers still reflect a rare disease considering an estimated 10 million women globally have breast implants.

There is no firm agreement on the exact frequency of the disease, known as breast implant-associated anaplastic large cell lymphoma. Published estimates ranging from 1 in 3,000 patients to 1 in 30,000 patients.

Diana Zuckerman, a researcher who has studied breast implant safety, called the removal of the devices inevitable.

“Either the company would voluntarily decide to withdraw them from the market to protect from lawsuits, or the FDA would persuade Allergan to do so,” Zuckerman said in an email.

In May, the country’s three largest breast implant manufacturers — Allergan, Sientra and Mentor — told CBS News textured implants have been extensively tested for safety and comply with FDA monitoring and that patient safety is their top priority.

___________________________________________________________

March 20, 2019   FDA NOTICE ON TEXTURED IMPLANTS

 

 

FDA News Release March 20, 2019

FDA issues warning letters to two breast implant manufacturers for failure to comply with post-approval study requirements

For Immediate Release

Today, the U.S. Food and Drug Administration issued warning letters to two breast implant manufacturers for failure to comply with their requirements, under their premarket approval orders, to conduct post-approval studies to assess the long-term safety and risks of their silicone gel-filled breast implants.

The FDA issued warning letters to Mentor Worldwide LLC of Irvine, California, and Sientra, Inc. of Santa Barbara, California.  Every manufacturer of approved silicone gel-filled breast implants is required to conduct post-approval studies to further evaluate safety and effectiveness of the products and to answer additional scientific questions about the long-term safety and potential risks of breast implants that their premarket clinical trials were not designed to answer.

“Post-approval requirements are critical to ensuring the safety and effectiveness of the medical products we regulate and we’ll continue to hold manufacturers accountable when they fail to fulfill these obligations,” said FDA Commissioner Scott Gottlieb, M.D. “We’re issuing these warning letters based on the manufacturers’ low recruitment, poor data, and low follow-up rates in their required post-approval studies. We expect these manufacturers to meet the pre-specified study requirements in order to ensure the collection of long-term data that can be used to inform long-term patient safety.  Post-approval studies, along with other surveillance tools such as adverse event reports, registries, and scientific literature, allow the FDA to help ensure the safety of medical devices and protect patients.”

The FDA’s warning letter to Mentor Worldwide LLC (Mentor) noted several serious deficiencies in the manufacturer’s post-approval study for its MemoryShape breast implant, first approved in 2013, including that the manufacturer had failed to enroll the required number of patients in the study. The action also notes Mentor had poor follow-up rates with patients in the study. Finally, the FDA notified Mentor that there were significant data inconsistencies in the study, including poor patient accounting and missing race and ethnicity data. While the FDA had concluded after reviewing several interim study reports submitted by Mentor that progress on the post-approval study appeared adequate at that time, the agency advised Mentor of concerns about patient enrollment, follow-up rates and data inconsistencies.

Mentor’s failure to address these concerns and comply with its post-approval study requirements is a violation of the firm’s pre-market approval order.

The FDA’s warning letter to Sientra, Inc. (Sientra) noted a serious deficiency in the manufacturer’s post-approval study for its Silicone Gel Breast Implants, first approved in 2013. The manufacturer had poor follow-up rates with patients. Currently, the manufacturer reported a follow-up rate of 61 percent, which is below the target follow-up rate. In the response to the manufacturer’s most recent interim study report, the FDA notified the manufacturer that the study progress was inadequate because of low follow-up rates. Sientra’s failure to address these concerns and comply with its post-approval study requirements is a violation of the firm’s pre-market approval order.

The FDA requested responses from both manufacturers within 15 working days of the issuance of the warning letters, with details about how the noted violations will be corrected. The FDA may take action for a failure to comply with post-approval orders, including pursuing applicable criminal and civil penalties, where appropriate.

The FDA’s actions today are part of the agency’s ongoing commitment to its public health mission of ensuring patient access to safe and effective medical devices. As part of the Medical Device Safety Action Plan, the FDA committed to streamlining and modernizing how the agency implements postmarket actions to address device safety issues to make responses to risks more timely and effective, including taking actions against manufacturers when their postmarket studies are non-compliant with any study requirements. The FDA has issued several warning letters in recent years to manufacturers who did not adequately fulfill certain postmarket study requirements, reflecting the agency’s commitment to take more aggressive actions against manufacturers who fail to comply.

In addition to the required post-approval studies, the FDA has taken additional steps to ensure the agency is monitoring the safety and risks of breast implants. For instance, FDA staff have coordinated with the American Society of Plastic Surgeons and the Plastic Surgeons Foundation to develop the Patient Registry and Outcomes for Breast Implants and Anaplastic Large Cell Lymphoma (BIA-ALCL) Etiology and Epidemiology (PROFILE), which collects real world data regarding patients who have a confirmed diagnosis of BIA-ALCL. The data collected from this registry, have contributed to a better understanding of BIA-ALCL and FDA communication updatesto the public regarding BIA-ALCL.

Additionally, the FDA has worked with multiple stakeholders to facilitate the development of the National Breast Implant Registry (NBIR) to provide a platform for collecting additional real world data on the safety and performance of breast implants. This newly launched registry will greatly add to the information we collect in our own post-approval studies about the long-term safety of breast implants, and potentially enhance our understanding of the long term safety and risks associated with breast implants.

The FDA remains committed to thoughtful, scientific, transparent, public dialogue concerning breast implant safety and effectiveness. The FDA welcomes public dialogue about breast implant safety and risk at the upcoming public meeting of the General and Plastic Surgery Devices Panel at the FDA’s headquarters in Silver Spring, Maryland on March 25-26, 2019, which will also be available via webcast.

Health care professionals and consumers should report any adverse events related to breast implants to the FDA’s MedWatch Adverse Event Reporting program.  The FDA monitors these reports and takes appropriate action necessary to ensure the safety of medical products in the marketplace.

End

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