FDA Acknowledges Link Between Breast Implants and Anaplastic Large Cell Lymphoma
By Hoffer & Sheremet, PLC, Michigan
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Twenty years ago, over $4 billion was paid to victims who became sick from silicone and other toxic chemicals leaking from their silicone breast implants. Silicone implants were taken off the market until 2006. Now research shows women are getting sick again.
The FDA has recently acknowledged that there are real health risks associated with implants. Implants may cause a type of non-Hodgkin's lymphoma: anaplastic large cell lymphoma (ALCL).
Recent lawsuits allege the implants cause a host of other injuries and complications as well, which are listed below. These lawsuits accuse Mentor Worldwide, a subsidiary of Johnson & Johnson, of negligently and intentionally designing and executing inappropriate studies designed to downplay the risks associated with silicone implants to the FDA.
What We Are Doing To Help
The tort system is designed to compensate victims and deter future tortious conduct. Twenty years ago, the system only partially worked. Only some women were compensated, and only some companies were deterred from placing unsafe products on the market.
Hoffer & Sheremet believes everyone deserves justice. Implant manufacturers cannot bury their heads in the sand or intentionally design and execute unreliable studies. If manufacturers knowingly placed unsafe implants on the market, we will hold them accountable. We are currently investigating and evaluating claims for women who have contracted ALCL or have had other complications attributable to breast implants. If you have been diagnosed with ALCL or have the symptoms listed below, and had breast implants after 2006, contact us today to be included in our investigation, and please visit our website.
History of Implant Concerns and Litigation
Early Concerns About Silicone Implants
This wave of lawsuits is not the first attack against silicone implants. Silicone breast implants were first developed in the 1960s. The manufacture and marketing was not regulated by the FDA, though, until 1976, when Congress passed the Medical Device Amendments. Originally, breast implants were "Class II" medical devices. In 1988, silicone implants were reclassified as Class III, requiring manufacturers to prove the safety and efficacy of the devices.
In April 1991, the FDA called for Premarket Approval Applications (PMA) from manufactures of silicone implants. In September 1991, the FDA decided there was not enough evidence to conclude the implants were safe or not safe, and it requested more data from manufacturers. In November of that year, an Advisory Panel concluded that, although the manufacturers failed to provide sufficient data to prove the implants were safe, the implants should be permitted to stay on the market. In January 1992, the FDA announced a voluntary moratorium while it reviewed new data. In other words, the manufacturers could choose whether or not they continued to sell the implants.
A month later, another Panel meeting was held. This time, the Panel recommended implants be removed from the market pending review of new data. In April 1992, the FDA limited sales to women undergoing breast reconstruction or replacement of existing silicone gel-filled implants. The FDA further dictated that these were to be considered investigation devices, and recipients should be followed through on adjunct clinical studies. In July 1992, Mentor proposed such a study, and it was approved by the FDA.
Throughout this time, women with silicone implants were noticing a variety of new symptoms and complications following implantation, including autoimmune disease. connective tissue disorders, neurological impairment and flu-like symptoms. Although the first lawsuit against Dow Corning was filed in 1977, it settled quietly. In 1984, a jury awarded a woman $1.5 million dollars in punitive damages against Dow Corning after internal documents were discovered in a Dow storage area. The evidence, though, was sealed. Lawsuits continued to be filed. It was decided the lawsuits would be handled more efficiently in a class action. Dow, and several other manufacturers, left the silicone implant business. Mentor did not. The class action was settled, but Dow, facing about 20,000 lawsuits and 410,000 claims in the settlement, filed for bankruptcy.
In the mid- to late-1990s, research purportedly debunked the connection between silicone implants and breast cancer and concluded the link to other diseases was "borderline."
A federal court appointed four independent experts to a panel to review the available scientific evidence. In December 1998, the panel concluded that the scientific evidence failed to show that silicone implants cause disease. In June 1999, a committee of 13 scientists assembled by the Institute of Medicine at the request of Congress reviewed the literature; it did not conduct its own independent research. That committee also concluded there was no link.
Mentor Is Allowed To Market And Sell Silicone Implants
In August 2000, the FDA approved Mentor's investigational device exemption study (i.e., a Core Study), which allowed Mentor to sell a limited number of silicone implants for augmentation.
In 2003, Mentor submitted its PMA. It was approved on the condition that Mentor and another manufacturer whose PMA was also approved, conducted 6 post-approval studies designed to evaluate the safety and effectiveness of the implants.
It is these 6 post-approval studies that are the target of the current lawsuits. The current lawsuits allege that Mentor intentionally and negligently designed and executed studies in a manner that avoided discovery of valid and reliable harmful data. It is thought that we can now establish what we couldn't in the 1990s - that silicone implants cause serious disease when they leak or rupture.
The FDA Links ALCL and Implants
In January 2011, the FDA identified a possible association between breast implants and the development of ALCL from reviewing available literature. But based on the limited data available at that time (maybe due in part to Mentor's failure to design follow-up studies in manner that maximized participants), the FDA could not confirm with statistical certainty.
To further investigate, the FDA partnered with the American Society of Plastic Surgeons to establish a case registry of women with breast implants who have been diagnosed with ALCL. In March 2017, the FDA confirmed the association between implants and ALCL. It had received a total of 359 medical device reports of breast implant-associated ALCL - including 9 deaths. The increased incidence of ALCL appears to be associated with textured-surface implants.
Signs of ALCL
ALCL cannot be detected on a mammogram. It is a blood cancer. Here are the early symptoms of ALCL:
Swelling of the lymph nodes, neck, armpit, or groin
Loss of appetite / weight loss
Raised, red bumps that don't go away and may itch
If you have any of these symptoms and have had breast implants, see your doctor immediately. Visit the Lymphoma Research Foundation for more information. And contact us for a free consultation.
Other Injuries and Complications
For decades women have attributed the following symptoms to silicone breast implants:
Connective tissue disorder
Severe joint and muscle pain
ABOUT THE AUTHOR: Hoffer & Sheremet, PLC
Hoffer & Sheremet, PLC, represents clients in medical malpractice, legal malpractice and appellate proceedings throughout Michigan. The firm prides itself on providing personal representation, treating each case as unique, and leading with innovation to achieve the best possible results for their clients.
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Disclaimer: While every effort has been made to ensure the accuracy of this publication, it is not intended to provide legal advice as individual situations will differ and should be discussed with an expert and/or lawyer. For specific technical or legal advice on the information provided and related topics, please contact the author.