Irvine, California-based Allergan issued today a global recall of its Biocell textured breast implants, going above and beyond an FDA request that the pharmaceutical company voluntarily withdraw specific models of its textured breast implants from the U.S. market.
The FDA request was based on an agency analysis indicating that the incidence of a rare form of immune system cancer, BIA-ALCL (breast implant-associated anaplastic large cell lymphoma), was six times more frequent in Allergan implants compared with other brands available in the U.S..
Internationally, textured breast implants have been linked to 573 cancer cases and the deaths of 33 women.
According to NBC News, 481 of those 573 cancer cases overall involved Allergan implants.
As reported by the New York Times, the implant manufacturer was known in 13 cases of death and in 12 out of the 13, the manufacturer was Allergan.
The FDA first became aware in 2011 of a possible link between breast implants and cancer. Its voluntary recall request lags behind the 38 other countries which have already recalled the Allergan implants.
According to an FDA press release, the recall is intended to ensure the removal of unused products from medical device suppliers and doctors’ offices.
The agency issued a safety communication specifying the known risks of these textured breast implants for health care providers, patients with implants and patients considering implants.
The FDA advises asymptomatic women to be on the lookout for changes around the breast implant area but does not advise implant removal.
Symptoms of BIA-ALCL, which develops not in the breast itself but in surrounding tissues, include swelling, pain and fluid accumulation in the implant area. For a complete list of possible symptoms along with information and resources about the condition, please visit www.biaalcl.com.
“Symptomatic women can reach out to us through the website and we can direct them to physicians familiar with the disease,” Michelle Forney, one of three advocates who created the BIA-ALCL website, said.
Forney, a human resources manager from Sacramento, California, had her textured Biocell implants removed in January 2018, after being diagnosed with BIA-ALCL.
Typically this cancer is cured by removing the implant and surrounding scar tissue, but if not detected and treated early it can be fatal.
Textured breast implants, which can be silicone or saline, have a suede-like coating which causes the development of scar tissue in order to reduce the likelihood of movement within the breast.
It’s estimated that 10 percent of the 400,000 women undergoing breast implant surgery in the U.S. each year have textured breast implants.
“I’m happy to see (this recall). However, what we know today I would say is much different than what we knew yesterday. I think now we know that the magnitude and the seriousness of this disease is changing rapidly, and it’s increasing at an alarming rate. We have now recorded 33+ deaths and that’s growing. From the announcement, I think now we’re at the starting line. I felt before like we were behind the starting line. At least today we can move forward and hopefully the doctors and the pathologists will see the seriousness of this disease and how rapidly it’s increasing and start supporting the women who are symptomatic,” Forney said. “It’s a step in the right direction for sure.”
“The next thing is that the FDA will look at the other manufacturers as well as following through with Allergan and strategizing to make sure that all their implant patients are notified of what the symptoms are. That’s what they say, let’s hope they do it,” she said.
Featured photo by Andrea Sarcos