The FDA has previously warned Sientra, Inc. and Mentor concerning their failure to do proper safety studies and comply with post-approval study requirements for their breast implants.
Textured breast implants linked to breast implant-associated anaplastic large cell lymphoma
What all the implants linked to BIA-ALCL have in common is that they are textured. In fact, BIA-ALCL, an otherwise rare form of T-cell lymphoma, seems to develop only in women who have implants with a textured surface or have had them in the past. (BIA-ALCL has also been diagnosed in at least four transgender women.) In the U.S., textured implants are used for post-mastectomy breast reconstruction more often than for cosmetic breast augmentation.
Researchers are unsure why the disease develops in the scar tissue capsule and fluid surrounding the implant. Some speculate that the rough, sandpaper-like surface of textured implants causes chronic inflammation that leads to lymphoma. Others believe that the rough surface and the greater surface area of a textured implant trap more bacteria, creating a biofilm that causes inflammation and leads to lymphoma. The more deeply textured Allergan Biocell implants are the most commonly linked with BIA-ALCL.
Breast implant side effects – knowledge is power
The most common symptoms of BIA-ALCL are swelling or pain in the area of the implant. Some patients also have a lump adjacent to the implant surface or a lump in the lymph node in the armpit. Other less common breast implant side effects may include enlarged lymph nodes, skin rash, fever, and weight loss.
Importantly, the symptoms often develop as long as 7 to 10 years after the implant is placed. Patients may consequently be lulled into a false sense of safety and security about their implants. Everyone who has had a breast implant, particularly a reconstructive implant, would be well advised to consult with a healthcare professional. More than ever, it appears to be important to know two things:
- Whether the implant was textured; and
- What company manufactured it?
A growing number of textured breast cancer implant lawsuits
The Allergan Biocell textured breast implant lawsuits have now been centralized in multidistrict litigation (MDL) in the U.S. District Court for the District of New Jersey. The purpose of consolidation is to expedite and coordinate discovery and pretrial proceedings for lawsuits that could ultimately number well into the hundreds.
New lawsuits against Mentor, Silimed Polyurethane, Eurosilicone, Nagor, Orion, and Poly Implant Prothèse would presumably not affect or be affected by that MDL, except to the extent that the factual evidence was held in common.
What did the pharmaceutical companies know, and when did they know it?
One question that is sure to emerge in these lawsuits is whether the manufacturers of the textured implants either knew or had reason to know that the devices were potentially dangerous for patients. A growing body of evidence suggests that they may have been.
The first case of BIA-ALCL was reported in a medical journal in 1997. In 2011, the FDA first reported a possible link between breast implants and the development of BIA-ALCL in a safety communication for health professionals and people who have or were considering breast implants. In 2016 the World Health Organization designated BIA-ALCL as a unique form of lymphoma.