courtesy of Jeff Weiner / Allergan
Allergen has announced a worldwide recall of textured breast implants associated with a rare cancer at the request of the Food and Drug Administration.
Biocell salt filled and silicone filled textured breast implants and tissue expanders are no longer marketed or sold in any market on which they are currently available.
The FDA stated in a statement that although the overall incidence of the cancer appears to be low, Allergan was asked to initiate the recall of Biocell implants "once evidence has been found that the product of a particular manufacturer is directly related "There are symptoms or problems, but it provides information that patients and providers must consider."
The FDA said it was calling for a "significant increase" apply for "breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), a type of non-Hodgkin's lymphoma. Since the last report in February, there have been 116 new cases and 24 deaths.
"Based on new data, our team concluded that public health measures are currently needed," said Amy Abernethy, Deputy Chief Inspector of the FDA
There were 573 cases of breast implants worldwide, according to the FDA. associated anaplastic large cell lymphoma (BIA-ALCL) and 33 deaths in patients. The agency said that 481 of the cases were due to Allergan implants, and among the deaths "12 of the 13 patients known to the implant manufacturer were confirmed to have an Allergan breast implant at the time of their BIA infection "ALCL Diagnosis."
Based on the latest data, the FDA states, "Our analysis shows that the risk of BIA-ALCL with textured Allergan BIOCELL implants is about six times greater than the risk of BIA-ALCL with Textured implants from other manufacturers in the US "
The FDA reported in 2011 on a possible link between implants and rare cancer. Abernathy announced that the agency continues to monitor reports in databases and patient registries, as well as scientific studies that point to risks.
Almost 314,000 people received breast implants in the US in 2018, according to the American Society of Plastic Surgeons. The report of the group does not distinguish between textured implants and other species.
"In the United States, the use of textured implants is much rarer than the use of textured implants in Europe and Asia," said plastic surgeon Daniel Maman, a New York-based assistant professor at Mount Sinai.
It is unclear whether texturing is actually responsible for the cancer or is only associated with a higher incidence of the disease. But Maman and others say that the surface can interact with the surrounding scar tissue that the body forms as an immune response to the implant.
"It is believed that this reaction causes the formation of the lymphoma," remarked Maman He uses only smooth, round implants. Given the risks associated with textured implants, he said, "It is very prudent and correct to remove them from the market."
The FDA's actions on Wednesday have changed when the adviser joined the FDA a few months ago The conclusion was that there was a lack of scientific certainty about the health risks that breast implants bring to the millions of women.
According to NPR's Patti Neighmond, at this time, "most panel members do not have enough evidence to shut down structured implants in the market and that larger, longer-term studies are needed."
Allergan said Wednesday that healthcare providers Biocell implants and tissue expanders should no longer be implanted and unused products should be returned to the company. It said it would also work with customers on how unused products can be returned.