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.”
Marine Vets who became fishing buddies attend Veteran’s Lake event https://t.co/urjZVlHYr2 via @starnewsmn
@FixesGames We're so sorry to hear about your father. If you'd like to make an appointment, please call 1-877-632-6789 or complete our online self-referral form: https://t.co/7W1ZW5Ftoj. Best wishes to you.
@HuggettLinda @FLAGALine We're thinking of you and your husband.
Five ways to make your healthcare job application stand out https://t.co/vBK8Ep0hZP via @vacareers #VAntagePoint
“For the first time, we’re getting truly curative therapies in many kinds of disease,” says Dr. Jim Allison. #immunotherapy #endcancer https://t.co/jTDR11Wgxa
It's back to the class for school districts across the Houston area. We have rounded up tips from some of our experts to help children and parents transition from summer to school. #BackToSchool https://t.co/xcCPwOUFq8
“Pig to human heart transplants 'possible within three years' Pioneer UK surgeon Sir Terence English says adapted organs could transform treatment” https://t.co/VAKjzUlbZz
.@UTHealth ranks on @Forbes Best Employers national list: https://t.co/9u5dvdZkXO
For the second straight year, Texas Children's Pulmonology was ranked No. 1 by U.S. News and World Report. Learn more: https://t.co/eFbNnpyHKm
Milwaukee Veteran receives Congressional Gold Medal for being one of the first African American Marines https://t.co/ga4iJ6SNao via @journalsentinel
RT @UHCougarFB: Camp is over. Season on tap.#GoCoogs https://t.co/ldk7enXFHQ
RT @uhparking: If you are on campus and looking for Visitor parking, don't forget all of the new visitor parking available in the new Garag…
RT @uhit: Who DOESN'T like #FreeStuff ??? Get ahead of those assignments and make sure to DL your #FREE copy of the Office 365 suite 😎 #Go…
RT @BranMart: If you ever want to know how much parents love their kids, just go to a college drop off ... 18 years of love showcased in se…
TAMU Health Sciences@TAMHSC
RT @TAMUmedicine: Happy to announce that Amy Waer, MD, FACS, assumes the role of interim dean for the Texas A&M College of Medicine on Sept…