This week the U.S. Food and Drug Administration finally requested that manufacturer Allergen issue a “voluntary” recall for its textured Biocell breast implants. The request comes two months after the FDA announced that despite having received a number of reports linking textured breast implants with a rare form of cancer known as anaplastic large cell lymphoma (ALCL) it would not remove the products from the U.S. market.
In a press statement, Allergen announced that “Biocell saline-filled and silicone-filled textured breast implants and tissue expanders will no longer be distributed or sold in any market where they are currently available.” The product has already been banned in other countries, including France, the Netherlands, and Canada.
On its part, the FDA continues to say that the cancer risk from Biocell implants is negligible. However, it requested the recall “once the evidence indicated that a specific manufacturer's product appeared to be directly linked to significant patient harm, including death.” That evidence consisted of a “significant increase” in reports of breast implant-associated (BIA) ALCL. 116 new cases of BIA-ALCL have come to light since the FDA issued its last report in February, over 20 percent of those cases were fatal.
To date, there have been a total of 573 BIA-ALCL cases reported worldwide. While Allergen is not the only manufacturer of textured breast implants, approximately 84% of the women who contracted BIA-ALCL had the Biocell product implanted.
BIA-ALCL is a form of non-Hodgkin's lymphoma. Medical science is unclear about the mechanism by which textured breast implants cause BIA-ALCL. Current theories suggest that inflammation, bacterial contamination, and genetic predisposition may all play a role. Fortunately, the disease can be readily treated with surgery if it is diagnosed early on. Otherwise, the patient may require chemotherapy and radiation treatments, which carry their own risks.
The FDA recommends that women who currently have Biocell implants and do not have symptoms of BIA-ALCL not have them removed. They should, however, be aware of possible signs, such as swelling and fluid buildup around the implant, in which case medical tests are called for. Women who are considering breast augmentation surgery should understand all the risks involved. In its statement, Allergan says that “patient safety is a priority,” and recommends that patients discuss any concerns they have with their surgeon before making any decisions.
There has been disagreement over the risks of textured breast implants. Part of this stems from misdiagnosis. BIA-ALCL symptoms can be mistaken for breast cancer, although the pathology differs. There has also been speculation about what manufacturers of these devices knew about the risks – and failed to share with the public. That question has already sparked a class action lawsuit against Allergen by its shareholders after the sale of the implants were suspended in Brazil and the European Union. Individual injury lawsuits against Allergen and other textured breast implant makers were filed starting last year.