WASHINGTON — Allergan issued a worldwide recall of Biocell textured breast implants and tissue expanders that have been linked to a rare cancer. The move came after the US Food and Drug Administration requested the manufacturer voluntarily recall the products.
“Allergan is taking this action as a precaution following notification of recently updated global safety information concerning the uncommon incidence of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) provided by the U.S. Food and Drug Administration (FDA),” according to a press announcement by Allergan.
Textured breast implants are less commonly used in the United States compared to other countries, according to the FDA. Specifically, macro-textured implants — the type of textured implant that Allergan manufactures — represent less than 5% of all breast implants sold in the United States.
“It’s our estimation that hundreds of thousands of women have these implants,” Dr. Binita Ashar, director of the office of surgical and infection control devices at the FDA, said during a press conference on Wednesday. She added that the FDA will get more information on those numbers in the coming weeks.
The specific textured breast implant products that have been recalled include Natrelle Saline-Filled breast implants, Natrelle Silicone-Filled breast implants, Natrelle Inspira Silicone-Filled breast implants, and Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Filled breast implants.
The recalled tissue expanders include the Natrelle 133 Plus Tissue Expander and Natrelle 133 Tissue Expander with Suture Tabs.
What breast implant patients should know
In 2011, the FDA first identified a possible association between breast implants and the development of a rare cancer called breast implant-associated anaplastic large cell lymphoma, or BIA-ALCL.
The FDA does not recommend the removal of these breast implant products in women without symptoms of BIA-ALCL, according to the agency’s announcement, but rather to know the symptoms and monitor the area around breast implants for any changes. If people experience any symptoms or changes, they should talk to their doctor.
The main symptoms of BIA-ALCL are swelling or pain in the area of the implant, which may occur years after the implant was placed. As of earlier this month, a total of 573 cases globally of anaplastic large cell lymphoma related to breast implants have been reported to the FDA. There have also been 33 patient deaths, the FDA said.
“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,” Dr. Amy Abernethy, the FDA’s principal deputy commissioner of food and drugs, said in the agency’s news release on Wednesday.
“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,” she said. “If action is needed in the future, we will not hesitate to do what is necessary to protect patients.”
In March, the FDA Medical Devices Advisory Committee’s General and Plastic Surgery Devices Panel convened to discuss the steps it would take to maintain surveillance of breast implant safety.
“We will continually evaluate any new information and may, as a result, take action regarding other breast implants, if warranted,” Dr. Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health said in Wednesday’s news release.
“In addition, we are continuing our assessment to determine whether the risk of developing BIA-ALCL is limited to specific models of textured, or all textured breast implants,” he said. “We continue to advise women and health care professionals that the use of breast implants is associated with a risk of developing BIA-ALCL and that the risk is greater with textured implants.”
The FDA also announced that it is considering recommendations to change the labeling of breast implants to include a boxed warning indicating health risks, among other possible actions to help share safety information.
‘Breast implants are not meant to be lifetime devices’
Breast augmentation was the most popular cosmetic surgical procedure performed last year, according to statistics from the American Society of Plastic Surgeons.
While most women have breast implants with no serious complications, as many as 20% of women who receive implants for augmentation have to have their implants removed within eight to 10 years, owing to complications, according to the FDA.
“Breast implants are not meant to be lifetime devices. They have a lifespan, and that might range from seven to 10-plus years, based on the implant and patient,” Dr. Tommaso Addona, a plastic surgeon and president of the Long Island Plastic Surgical Group in New York, said in March.
He added that he often discusses benefits and risks with his own patients.
“We do discuss complications. Those range from scarring around the implant, sometimes soreness and discomfort from the implant … to in the last seven years, probably a bit more, we’ve become more acutely aware of a specific type of lymphoma that is associated with breast implants,” he said. “What the general public should appreciate is, as doctors and clinicians, we always want what’s best and safest for our patients. We’re constantly not only educating ourselves but educating our patients.”