Allergan has announced a global recall of textured breast implants that are linked to a rare type of cancer, at the request of the Food and Drug Administration.
"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," according to a company statement Wednesday.
The FDA said in a statement that while the overall incidence of the cancer appears to be low, it asked Allergan to initiate the Biocell implant recall "once the evidence indicated that a specific manufacturer's product appeared to be directly linked to significant patient harm, including death."
The agency does not recommend that people who already have the textured implants get them removed unless there are symptoms or problems, but it is providing information for patients and providers to consider.
The FDA said it requested the recall after a "significant increase" in cases of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), a type of non-Hodgkin lymphoma. Since its previous report in February, there have been 116 new cases and 24 deaths.
"Based on new data, our team concluded that action is necessary at this time to protect the public health," said FDA Principal Deputy Commissioner 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 481 of the cases are attributed to the Allergan implants, and that among the deaths "12 of the 13 patients for which the manufacturer of the implant is known, 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 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."
The FDA first reported on a possible connection between implants and the rare cancer back in 2011, and Abernathy said the agency has continued to monitor reports in databases and patient registries and scientific studies pointing to risks.
Nearly 314,000 people received breast implants in the U.S. in 2018, according to the American Society of Plastic Surgeons. The group's report does not distinguish between textured implants and other kinds.
"In the United States, the use of textured implants is much less common than the use of textured implants in Europe and Asia," said plastic surgeon Daniel Maman, who is in private practice in New York and an assistant professor at Mount Sinai.
It's not clear whether the texturing is actually responsible for the cancer or is just 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's that response that is believed to cause the formation of the lymphoma," Maman said, noting that he only uses smooth, round implants. Given the risks linked to textured implants, he said, "taking them off the market is very prudent and the right approach."
The FDA's action Wednesday is a change in course from a few months ago when advisers concluded there was a lack of scientific certainty about the health risks that breast implants pose to the millions of women who have them.
At the time, as NPR's Patti Neighmond reported, "most members of the panel said there's not enough evidence yet to rush textured implants off the market and that larger, longer-term studies are needed."
Allergan said Wednesday that healthcare providers should no longer implant the Biocell implants and tissue expanders and that unused products should be sent back to the company. It said it would also work with customers about how to return unused products.
RACHEL MARTIN, HOST:
A type of textured breast implant linked to a rare type of cancer has been recalled around the world. And the FDA has asked the company to pull the implants from the American market.
NPR's Allison Aubrey reports.
ALLISON AUBREY, BYLINE: The FDA first reported a possible link between textured breast implants and a rare type of lymphoma back in 2011. Now, the agency has new information. It has found that specific types of textured implants manufactured by the company Allergan appear to be directly linked to the harm and to some deaths.
Daniel Maman is a plastic surgeon in New York. He says given the risks linked to these textured implants...
DANIEL MAMAN: Taking them off the market was a prudent and the right approach.
AUBREY: Every year, about 300,000 people receive breast implants in the U.S. Many surgeons, like Maman, only use smooth, round implants. The textured ones are less commonly used here compared to Europe and Asia. Now, worldwide, the FDA has documented 573 cases where people who got the implants developed a rare type of lymphoma. And among those, 481 cases are attributed to Allergan's textured implants. In addition, a dozen women with the Allergan implants have died from the rare cancer.
MAMAN: I personally have not used a textured implant in at least five years because of this exact reason that they were taken off the market.
AUBREY: As scary as this may sound, the FDA says, overall, the incidence of implant-related lymphoma is relatively low, given the hundreds of thousands of implants performed each year. And in a statement, Allergan says it's taking this action to recall its products as a precaution.
Now, it has not been clear whether texturing is responsible for the cancer or just associated with a higher risk. But the latest thinking is that the texture on the implant has a physiological response and interacts with surrounding scar tissue that forms after the implants are put in.
MAMAN: And it's that response that is believed to cause the formation of this lymphoma.
AUBREY: As for people who already have the textured implants, the FDA does not recommend removing them unless there are symptoms or problems. But surgeon Daniel Maman says it is possible to take them out.
MAMAN: Removing implants is really not a big deal at all. But surgery is surgery. Any surgery has its inherent risks, so it's heavily dependent on the patient and the circumstance.
AUBREY: The FDA is providing information to both patients and to providers who have questions about possible next steps. Allison Aubrey, NPR News, Washington.
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