The to pull certain textured breast implants from the U.S. market due to the risk of breast implant-associated anaplastic large cell lymphoma (ALCL).
Allergan said it would comply and that it was moving forward with a worldwide recall of six products in its Natrelle line of implants and tissue expanders:
- 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
- Natrelle 133 Plus Tissue Expander
- Natrelle 133 Tissue Expander with Suture Tabs
While incidence of breast implant-associated ALCL, appears to be "relatively low," said FDA Principal Deputy Commissioner Amy Abernethy, MD, PhD, during a press briefing on Wednesday, "once the evidence indicated that Allergan'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."
show that 573 cases of breast implant-associated ALCL have been reported worldwide, 116 new cases since the FDA's last update in March. Of these, 481 cases of ALCL were linked with Allergan's implants.
The agency also updated its figures on patient deaths, which now total 33, and said that in the 13 deaths where the implant manufacturer was known, 12 of the patients were confirmed to have had Allergan breast implants at the time of their ALCL diagnosis. The remaining patient had a smooth implant at the time of diagnosis but had previously had a textured implant from another manufacturer.
"The FDA has been diligently monitoring this issue since we first identified the possible association between breast implants and ALCL in 2011," Abernethy said in a statement.
An FDA analysis said the risk of ALCL with Allergan BIOCELL textured implants was approximately six times that of textured implants from other manufacturers in the U.S.
"The FDA does not recommend removal for patients without symptoms due to potential risks," said Jeff Shuren, MD, JD, director of the FDA's Center for Devices and Radiological Health. He added that the agency could potentially take further action on breast implants if it determines the risk of breast implant-associated ALCL is linked to textured breast implants from other manufacturers or all textured implants.
During the briefing, Shuren said most of the cases of implant-associated ALCL were reported abroad, where roughly 80% of breast implants are textured products.
In the U.S., about 10% of implants are textured. "Of those, only about half are these Allergen BIOCELL textured implants," he said.
Joshua Brody, MD, Director of the Lymphoma Immunotherapy Program at the Tisch Cancer Institute at Mount Sinai in New York City, explained in an email that inflammation induced by certain implants increases the likelihood of cancer development, which then can "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," he said.
Binita Ashar, MD, of the FDA's Center for Devices and Radiological Health, said other hypotheses involve biofilm formation.
"Plastic surgeons are looking at different techniques to reduce the biofilm formation," she said. "But we have no specific understanding of precisely what it is about the texturing that causes the lymphoma -- only to know that texturing increases the risk overall over smooth implants."
Ashar reiterated that removal should only occur in the case of an implant-associated ALCL diagnosis and that the surrounding capsule, or scar tissue, around the implant should also be removed in such cases.
"It's important to make a diagnosis because it changes the type of operation that the patient may need," she said. "If she does not have breast implant-associated ALCL, a simple removal operation that leaves the scar tissue in place is what occurs."