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FDA Recall of Allergan Textured Breast Implants

Investigations into the health risks of breast implants have been going on since the 1980s. Since 2011, one area of focus has been on complaints alleging that textured breast implants cause cancer. While the FDA has repeatedly examined this issue, it only took action this summer. In July, the FDA requested that Allergan recall specific models of its textured breast implants from the U.S. market due to the risk of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) BIA-ALCL. Why the change in FDA policy?

In the U.S., less than 5 percent of implants sold are textured breast implants. However, recent data indicates a significant increase in cases of BIA-ALCL worldwide with a high percentage of them specifically involving Allergan’s textured breast implants. As a result, the FDA decided that a voluntary recall was warranted to protect the public. The FDA also noted that France, Canada and Australia have also taken actions to remove certain textured breast implants, including those made by Allergan.

BIA-ALCL is a type of non-Hodgkin’s lymphoma – a cancer of the immune system, not breast cancer. It is typically found in the scar tissue and fluid near the implant but can spread throughout the body. The risk of BIA-ALCL is higher for textured breast implants than smooth surface implants. While overall risks are low, this cancer can lead to death especially if not treated properly.

In response to the FDA’s request, Allergan is recalling all their BIOCELL textured breast implant products worldwide, including: Natrelle Saline-Filled breast implants, Natrelle Silicone-Filled breast implants, Natrelle Inspira Silicone-Filled breast implants, and Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Filled breast implants. In addition, tissue expanders including Natrelle 133 Plus Tissue Expander and Natrelle 133 Tissue Expander with Suture Tabs are also being recalled. While this is a significant step, it will not minimize the litigation already pending against the company in various jurisdictions and in fact, may result in more litigation due to the adverse publicity.

The recall is limited to Allergan, but textured implants are also sold by Johnson & Johnson and Sientra and both companies received recent FDA warning letters related to deficiencies in their post-approval study for silicone breast implant approvals.

What is notable about the FDA’s actions and litigation is the lack of a definitive link between the textured implants and BIA-ALCL. Experts do not fully understand the cause of BIA-ALCL. A 2016 study suggests that “chronic inflammation via bacterial infection may be an etiological factor.” Possible contributing factors may include “reactions to implant particles, long-term allergies, genetic factors, or reactions to bacteria that grow on the implant’s surface.” Notwithstanding this, the FDA has issued new guidelines for doctors and patients regarding the use of implants because of the serious questions that have been raised by the data gathered about known cases.

The FDA is continuing to monitor and analyze new reported cases, which may have a substantial impact on new and pending litigation related to breast implants. Depending on the basis of the claim, Plastic Surgery experts may play a crucial role in litigation to testify about appropriate use of textured breast implants. Oncology experts may also be needed to consult regarding proper diagnosis and treatment of BIA-ALCL.

If you need assistance finding nationally recognized Plastic Surgeons or Oncologists for your case, please contact Elite Medical Experts.