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What Women Need to Know About the Textured Breast Implant Recall

What Women Need to Know About the Textured Breast Implant Recall

By Stacey Feintuch

Created: 07/31/2019
Last Updated: 08/01/2019

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Women with breast implants are all around us. And many of these women have no health issues at all from these implants.

However, Allergan voluntarily issued a worldwide recall of Biocell textured breast implants and tissue expanders that have been linked to a rare cancer. The U.S. Food and Drug Administration requested that the manufacturer voluntarily recall the products.

The FDA announced there are now 573 cases of this cancer worldwide and 33 people have died, a significant increase since the agency's last update earlier in 2019—reflecting 116 new cases and 24 more deaths.

The risk of developing anaplastic large cell lymphoma, known as BIA-ALCL, with Allergan BIOCELL textured implants is about six times that of becoming ill with textured implants from other manufacturers available in the United States, the FDA said.

Of the 573 cases of BIA-ALCL, 481 were attributed to Allergan implants, and 12 of the 13 patients for whom the implant manufacturer was known had an Allergan implant when they were diagnosed, the FDA added.

The main symptoms of BIA-ALCL are swelling or pain in the area of the implant, which may occur years after you received it. "If a woman has had an implant for a number of years and one side suddenly gets larger, that could mean there is a fluid collection which in turn could be indicative of the lymphoma—but not necessarily," says Thomas Sterry, MD, a plastic surgeon who practices in New York City. "Therefore, if an implanted breast gets larger some years after the prosthetic was put in place, a needle aspiration should be done to be sure there is no lymphoma." If you have a breast implant and notice anything unusual, speak with your physician, says Lara Devgan, MD, MPH, FACS, PLLC, a plastic and reconstructive surgeon who practices in New York City.

Do you need to worry?

The FDA doesn't recommend removal of these implants in women without symptoms of BIA-ALCL. Instead, know the symptoms and monitor the area around the breast implants for any changes. If you experience any symptoms or changes, contact your doctor. "The FDA has NOT recommended removing textured implants from Allergan," says Dr. Sterry. "On a grand scale, if we started removing all the textured implants from Allergan that had been inserted, we would start seeing complications (eventually) that wouldn't justify the risk of the lymphoma."

When detected early, BIA-ALCL can usually be cured by surgery, where the implant and scar tissue are removed. Some women also need chemotherapy and/or radiation because the cancer has spread. And for a small number of women, it can be fatal.

How common are textured breast implants in the U.S.?

Textured breast implants are less commonly used in the United States compared to other countries, says the FDA. The type of textured implants that Allergan manufactures represent less than 5 percent of all breast implants sold in the United States.

"Women who have textured implants and are otherwise feeling fine are advised to follow up with their doctors for normal and routine screening," says Dr. Devgan. "If a patient notices anything unusual, such as development of a seroma or fluid collection of the breasts, these symptoms should be investigated. Otherwise, normal surveillance protocols such as annual breast exams, mammograms when applicable and MRIs when applicable should be maintained."

Most, but not all, implants in the United States are smooth. Textured ones are more popular in Europe. Health care providers and their patients sometimes prefer textured implants because they're more likely to stay in position than smooth ones. (Tissue grows into the rough surfaces on textured ones to help hold them in place).

What should I remember if I'm considering a breast augmentation or reconstruction?

Whether you're interested in breast implants for cosmetic purposes or cancer reconstruction, speak with a board-certified plastic surgeon who can tell you what's right for you. Discusses benefits and risks/complications. "The hypothesis underlying this voluntary recall is that texturing of certain breast implants may result in an inflammatory reaction that is linked to a rare but present risk of BIA-ALCL," says Dr. Devgan. "Smooth breast implants aren't associated with that risk, and I believe that these devices are safe and effective. I would continue to recommend smooth non-textured implants to a family member, friend or patient who desired them and was an appropriate candidate."

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