Breast implants recalled, manufacturers sued over rare form of cancer
A group of women are suing Allergan Inc., alleging that the breast implant manufacturer failed to disclose the cancer risks associated with its textured breast implants and used a loophole in the FDA’s reporting requirements to hide instances of serious injury related to the implants. The Judicial Panel on Multidistrict litigation sent the suits to federal court in New Jersey in December 2019.
Lawsuits have also been filed against manufacturers Sientra Inc. and Mentor Worldwide LLC over similar claims. Both Sientra and Mentor were sent warning letters by the FDA in March 2019 for failing to comply with post-approval study requirements for their respective implants.
The letter to Sientra reads, “This failure prevents adequate continuing evaluation of the safety, effectiveness, and reliability of the device at this stage (Year 3) and will prevent such an evaluation at the end of the study (Year 10)… FDA also advises that failure to conduct any post-approval studies in compliance with the institutional review board regulations in 21 C.F.R. Part 56 and the informed consent regulations in 21 C.F.R. Part 50 may be grounds for withdrawal of approval of the PMA (1)."
The lawsuits came after studies demonstrated an association between breast implants and the development of a rare form of cancer, called breast implant-associated anaplastic large cell lymphoma (BIA-ALCL).
What is BIA-ALCL?
BIA-ALCL is a type of non-Hodgkin’s lymphoma that is most often found in the scar tissue and fluid near breast implants, though it can spread throughout the body as well. The possible association between breast implants and the development of ALCL was first discovered by the FDA in 2011 after conducting a thorough review of scientific literature published from 1997 to 2010.
According to the FDA, “an individual’s risk of developing BIA-ALCL is considered to be low; however, this cancer is serious and can lead to death, especially if not treated promptly. In most patients, it is treated successfully with surgery to remove the implant and surrounding scar tissue, and in some patients, also treatment with chemotherapy and radiation therapy (2).”
Because the cancer is so rare, the agency is not yet recommending that women with these types of implants remove them. But they say women should check with their doctor if they have symptoms. Common symptoms of BIA-ALCL include pain, persistent swelling, and the presence of a mass near or around the area of the breast implant.
Concerns over BIA-ALCL led to recalls of certain implants
In July 2019, the FDA requested that Allergan voluntarily recall certain breast implants from the U.S. market over the risk of BIA-ALCL. Following the request, Allergan moved forward with a worldwide recall of their BIOCELL textured breast implant products (3). The FDA called for this removal after new information showed that the BIOCELL implants with a textured surface accounted for a disproportionate number of the cancer cases. The FDA’s move follows similar recalls in France, Australia and Canada.
As of January 5, 2020 the FDA had received 733 medical device reports of BIA-ALCL in the U.S. and globally (4). The agency vowed that they would continue their focus on gathering available evidence and analyzing all available information to protect the health of women. “To this end, the agency has requested that all breast implant manufacturers provide quarterly trending analyses of adverse events, including BIA-ALCL, and require reporting individual events in the adverse event database for devices and in existing registries (5).”
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If you or a loved one experienced painful side effects, including ALCL, from breast implants, you may be entitled to compensation without ever going to court.
We invite you to join the community of women who are holding manufacturers accountable by asserting your claim. We’d be honored to speak with you.
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