FDA’s Proposed Breast Implant Warnings

Image of breast implants on purple table showing different types and styles

FDA’s Proposed Breast Implant Warnings

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On Wednesday, the FDA asked manufacturers and medical professionals to better inform women about the potential hazards of breast implants. The federal agency has approved saline and silicone gel implants for augmenting breast sizebreast cancer reconstruction, correcting developmental defects, and to “improve: the result of previous surgery, but implants are not without risks. Here’s what we know about the FDA’S proposed breast implant warnings:

“The Food and Drug Administration and the major plastic surgery societies are all working together to do further research more closely looking into implant risks, which will help future patients receiving implants know they’re getting the safest approaches and technologies,” says Anne Peled, MD, a board-certified plastic surgeon practicing aesthetic, reconstructive, and breast oncologic surgery in San Francisco. Although the FDA’s recommendation won’t yet be formally implemented, Dr. Peled says it’s worthy of the attention of doctors, manufacturers, and, most of all, survivors.

In rare cases, people who receive implants may wind up with a form of lymphoma called breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), or a full-body condition called breast implant illness (though this hasn’t been well-studied yet), says Dr. Peled. “More common risks of implants include hardening over time, which is called capsular contracture; infection; rupture or deflation; and malpositioning,” she says. The FDA adds that the longer you’ve had implants, the more likely you are to experience complications.

If you’ve received implants already, Dr. Peled says the FDA news should prompt you to pay attention to the signs and signals your body relays to you.  “Anyone who has had breast implants placed for breast augmentation or reconstruction should see their surgeon once a year to check on their implants. Sooner than that if they develop any new breast signs or symptoms such as swelling, pain, masses, or change in the shape of their breasts,” she says.

Furthermore, if you’re a breast cancer survivor who’s considering reconstructive options, remember that you have choices. “There are a number of reconstructive options available for women who have had both lumpectomy and mastectomy and these can be done not only at the time of breast cancer surgery, but also any time after treatment is complete,” says Dr. Peled. Take the time to speak with your doctor to weigh the pros and cons of the many implants on the market before making whatever decision feels right to you and your body.