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The U.S. Food and Drug Administration announced a voluntary nationwide recall of certain types of textured breast implants on Wednesday due to their cancer risk.
The manufacturer Allergan recalled its Biocell textured breast implants from suppliers and doctors’ offices, in order to protect from breast implant-associated anaplastic large cell lymphoma (BIA-ALCL).
It follows an increase of 116 new cases of BIA-ALCL globally and 24 deaths since earlier this year (France, Canada and Australia have already taken similar action). About 84 percent of BIA-ALCL cases are attributed to Allergan implants, opposed to other FDA-approved brands Mentor, Ideal and Sientra.
Beverly Hills and Los Angeles-based plastic surgeons tell The Hollywood Reporter that there’s no need to panic, since textured breast implants are uncommon in the U.S. compared to other countries (namely those in Europe and South America). Only about five percent of all implants in the U.S. are textured — which grip the chest to avoid movement, desirable for shaped breast implants — while most are smooth.
Plastic surgeon Dr. Robert Cohen, of Emerage Medical in West Hollywood, tells THR that ALCL is “extremely rare” and has a greater than 90 percent cure rate with a surgery to entirely remove the implant and scar tissue. He no longer uses many textured implants due to patients’ concerns and stopped using Biocell more than five years ago (the FDA noticed a possible connection between breast implants and ALCL in 2011 and told doctors and patients about potential risks). Similarly, Dr. T.Y. Steven Ip, a plastic surgeon with locations in Beverly Hills, Newport Beach and New York, says he has used textured implants in the past but, as issues have been raised, has informed his patients about benefits and downsides.
Dr. Gabriel Chiu of star-loved Beverly Hills Plastic Surgery Inc. says his office uses about 99 percent Mentor breast implants (only when the patient already has Allergan implants from another clinic does Chiu use Allergan replacements under warranty). Since Chiu’s work is almost entirely cosmetic, he doesn’t often use textured breast implants, which are mainly reconstructive, he says.
Dr. Rady Rahban of Beverly Hills stopped using the textured implants about a year ago, adding that texturing is used with shaped or anatomical implants, such as teardrops. “You can’t stitch implants to the wall of the chest, so the texturing was a Velcro effect that prevented the implants from rotating,” Rahban tells THR.
Ip explains that Southern California residents seeking textured implants typically fall into one of two categories.
The first type of people are usually fitness-oriented, who want to put the implant above the muscle. “If you’re real physical like a cross-fit competitor, body builder or yoga instructor and you’re constantly flexing the muscle and you don’t want the muscle disturbed, most of the times putting implants above the muscle is the better option,” Ip says. “When you put implants above the muscle with a smooth implant, the problem is that you have a higher risk of forming an internal scar around the implant.” So they may turn to textured implants to reduce internal scarring risks.
The second group of people in L.A. seeking textured augmentation are those with sloped ribs: “One of the problems with smooth implants … is that with that angulation of their ribs, the implants can slip and fall to the side,” Ip says. “A textured implant with more friction on them grab on better. They kind of stay in the same spot; they don’t fall as much and they stay locked in.”
The doctors agree it’s best to recall the products to be safe and want to assuage any patient panic.
“It’s really affected the other parts of the world before us, but I think for safety reasons, I think it’s a good move to just pull it off the market. Why subject the population to even that small, small risk?” Ip says.
“Moving forward, I don’t think the right move is that all women with textured implants suddenly call their doctors, run in and have their implants removed. I do think as a result of having more knowledge, people can be aware of symptoms of the implant-related disease and be more cautious, but I don’t think this warrants any kind of panic,” Rahban adds.
Cohen concurs: “Don’t panic, we’re on top of things.” He doesn’t want to see patients hurrying to their plastic surgeons, because they’re scared they’re going to get cancer. “Statistically speaking, it’s an extraordinary low risk.”
The FDA does not recommend people with the recalled breast implants get them removed unless symptoms arise. If swelling or redness develops, the patient can consider removing them and replacing them with smooth implants, Ip says. “If they want them out, that’s their prerogative,” Cohen adds. Chiu was told by an Allergan rep that removal or replacement would be the financial responsibility of the patient.
“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 in a statement. “Our team concluded that action is necessary at this time to protect the public health.”
Some of the products recalled include 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 and Natrelle 133 Tissue Expander with Suture Tabs.
Allergan said that Biocell saline-filled and silicone-filled textured breast implants, as well as tissue expanders, will no longer be distributed or sold. “Patient safety is a priority for Allergan. Patients are advised to speak with their plastic surgeon about the risks and benefits of their implant type should they have any concerns,” the Ireland-based pharmaceutical company announced.
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