With permission from Jeff Weiner / Allergan
The Allergen has announced a global recall of textured breast implants linked to a rare type of cancer, at the request of the Food and Drug Administration.
"Biocell salt-filled and silicone-filled textured breast implants and tissue furthermore will no longer be distributed or sold in any market where they are currently available," according to a company statement Wednesday.
The FDA said in a statement that while the overall incidence of cancer appears to be low, it asked Allergan to initiate the recall of the Biocell implant "when the evidence indicated that a particular manufacturer's product appeared to be direct linked to significant patient injury, including death. "
The agency does not recommend that people who already have the structured implants get them removed unless there are symptoms or problems, but it provides information for patients and providers to consider.
The FDA said it requested recall after a "significant increase" in cases of large implanted anaplastic large cell lymphoma (BIA-ALCL), a type of non-Hodgkin's lymphoma. Since the previous report in February, 116 new cases and 24 deaths have occurred.
"Based on new data, our team concluded that action is needed at this time to protect public health," said FDA Vice-Chancellor Amy Abernethy.
Overall, according to the FDA, there have been 573 cases of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) and 33 patient deaths worldwide. The Agency said that 481 of the cases are attributed to Allergan implants, and that among the deaths, "12 of the 13 patients known to the implant manufacturer are confirmed to have an Allergan breast implant at the time of their BIA ALCL diagnosis."
Based on the latest data, the FDA said, "our analysis shows that the risk of BIA-ALCL with Allergan BIOCELL structured implants is about six times the risk of BIA-ALCL with structured implants from other US marketers"
The FDA first reported a possible relationship between implants and the rare cancer in 2011, and Abernathy said the agency continued to monitor reports in databases and patient records and scientific studies that pointed to risk.
Nearly 314,000 people received breast implants in the United States in 2018, according to the American Society of Plastic Surgeons. The group's report does not distinguish between structured implants and other types.
"In the United States, the use of structured implants is much less common than the use of structured implants in Europe and Asia," said plastic surgeon Daniel Maman, who is in private practice in New York and an assistant professor at Sinai Mountain.
It is not clear whether the structure is actually responsible for the cancer or is only associated with a higher incidence of the disease. But Maman and others say the surface can interact with the surrounding scar tissue that the body forms as an immune response to the implant.
"It is the response that is believed to cause lymphoma formation," Maman said, noting that he is using only smooth, round implants. Given the risks associated with structured implants, he said, "taking them out of the market is very prudent and proper approach."
The FDA's action on Wednesday is a change of course from a few months ago when advisors concluded that there was a lack of scientific certainty about the health risks posed by breast implants to millions of women who have them.
At that time, as NPR's Patti Neighmond reported, "most panel members said that there is not yet enough evidence to prevent structured implants, the market and that larger, longer-term studies are needed."
Allergan said Wednesday that health professionals should no longer implant the Biocell implants and tissue extenders and that unused products should be returned to the company. It said it would also work with customers on how to return unused products.