The Food and Drug Administration has requested that the manufacturer voluntarily recall certain breast implants and tissue expanders from the market to protect women from risks such as breast implant-associated anaplastic large cell lymphoma.
The Food and Drug Administration (FDA) has requested that Allergan, a breast implant manufacturer, voluntarily recall from the market certain textured models of its breast implants and tissue expanders to protect women from risks associated with these products. This action by the FDA is intended to protect women from breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) by taking specific models of Allergan’s textured breast implants off the U.S. market due to their association with BIA-ALCL.
“Although the overall incidence of BIA-ALCL appears to be relatively low, once the evidence indicated that a specific manufacturer’s product appeared to be directly linked to significant patient harm, including death, the FDA took action to alert the firm to new evidence indicating a recall is warranted to protect women’s health,” said Dr. Amy Abernethy, principal deputy commissioner for the FDA.
Allergan responded to the FDA’s request and has notified the agency that it is issuing a worldwide recall of its BIOCELL textured breast implant products, including:
- Natrelle Saline-Filled breast implants
- Natrelle Silicone-Filled breast implants
- Natrelle Inspira Silicone-Filled breast implants
- Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Filled breast implants
The recall also includes tissue expanders used by patients prior to breast augmentation or reconstruction, including:
- Natrelle 133 Plus Tissue Expander
- Natrelle 133 Tissue Expander with Suture Tabs
"The recall of these textured implants is a big deal in protecting women from the potential risks of developing, and dying from, this rare type of aggressive lymphoma," said Dr. Joshua Brody, director of the Lymphoma Immunotherapy Program at The Tisch Cancer Institute at Mount Sinai. "While case reports have suggested a potential link between some types of breast implants and this disease, anaplastic lymphoma. For over 20 years, it has taken time to gain sufficient evidence to suggest, and understand, the causality. Some types of implants induces inflammation which can both increase the chance of developing cancer, and also help to 'hide' developing cancers from the immune system. Many cases of implant-associated lymphoma have developed mutations and expression of immune-suppressive proteins which prevent anti-tumor immune cells from clearing the cancer, and these chances likely begin with the inflammation induced by some implants. By preventing further use of these implants, the FDA is helping women to protect themselves from the medically serious and emotionally exhausting effects of these risks."
The FDA has also issued a safety communication today for patients with breast implants – and patients considering breast implants
– as well as their health care professionals, outlining the known risks of breast implants and what patients should know when checking for symptoms of BIA-ALCL, such as swelling and pain in their breasts. “The FDA does not recommend removal (of implants) for patients without symptoms due to potential risks, but we provide helpful information for patients and providers to consider when discussing next steps,” said Dr. Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health.
In a July 24 update to its BIA-ALCL webpage, the FDA states that there have been 573 cases of BIA-ALCL and 33 patient deaths from it across the globe; of these cases, 481 are associated with Allergan implants. The FDA’s safety communication statement said that, based on the most current information, including data submitted after an FDA panel meeting in March
, “FDA analysis demonstrates that the risk of BIA-ALCL with Allergan BIOCELL textured implants is approximately six times the risk of BIA-ALCL with textured implants from other manufacturers marketing in the U.S., and continued distribution of Allergan’s BIOCELL textured breast products/implants would likely cause serious, adverse health consequences and potentially death from BIA-ALCL."
The recall also is intended to ensure that any remaining products are removed from suppliers’ and doctors’ offices.
“The FDA has been diligently monitoring this issue since we first identified the possible association between breast implants and ALCL in 2011 and, at that time, communicated to patients and providers that there is a risk for women with breast implants, more frequently occurring in women with textured implants, for developing this disease,” said Abernethy. “Based on new data, our team concluded that action is necessary at this time to protect the public health. We will continue to monitor the incidence of BIA-ALCL across other textured and smooth breast implants and tissue expanders as well as other devices intended for use in the breast. If action is needed in the future, we will not hesitate to do what is necessary to protect patients,” she added.