Pharmaceutical firm Allergan issued a global recall this week of a specific line of textured breast implants and tissue expanders after the U.S. Food and Drug Administration requested that the Ireland-based company voluntarily pull these products off the shelves due to their associated risk of cancer.
The implants are linked to breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), a rare type of lymphoma that can develop around textured breast implants. BIA-ALCL is not to be confused with breast cancer.
“The company feels that the risks exceed the benefit and that’s why they pulled it,” said Sebastian Winocour, M.D., assistant professor in the Michael E. DeBakey Department of Surgery at Baylor College of Medicine and member of the Dan L Duncan Comprehensive Cancer Center at Baylor said. “The concept that a foreign body causes a cancer is somewhat unusual. We put in implants for many reasons—knee replacements, heart valves and hip replacements, but breast implants are frequently placed in patients undergoing reconstruction for breast cancer. That’s what makes this so anxiety-provoking not just for patients, but also for physicians.”
According to the FDA, there are 573 total cases and 33 deaths caused by BIA-ALCL around the world. Out of the total cases, 481 of them pointed to Allergan implants. Of the 33 deaths, the FDA was able to identify the implant manufacturers of 13 cases; 12 were confirmed to be made by Allergan.
“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,” said FDA Principal Deputy Commissioner Amy Abernethy, M.D., Ph.D., in a press release.
This recall comes months after the FDA held a two-day hearing on the long-term safety of textured breast implants earlier this year and, ultimately, decided not to ban textured breast implants.
Textured breast implants are often used instead of traditional implants because they hold their position better and can reduce the risk of scarring. Textured implants are also used in some patients who have undergone mastectomies.
“Your tissue grows into the texturing and that allows the implant to not rotate or flip,” Winocour, said. “For anatomical implants to be made with a more natural, teardrop shape, they can be implanted without the concern of it rotating or flipping, and it can restore the appearance of a natural looking teardrop-shaped breast.”
But these advantages of textured implants come at a price: the risk of developing BIA-ALCL.
The worldwide recall for new textured breast implants and tissue expanders took effect immediately on Wednesday.
“As this information comes out, people may realize they have textured implants or BIOCELL implants in them,” Winocour said. “I think it’s important that they speak with their plastic surgeons to try to find as much information as they can regarding this.”
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