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Allergan Textured Breast Implants Recalled to Protect Patients

Last week the Food and Drug Administration requested Allergan to voluntarily recall their Natrelle BIOCELL textured breast implants to protect patients from the increased risk of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). BIA-ALCL is not a breast cancer. It is classified as a non-Hodgkin’s lymphoma, which is a cancer of the immune system. The lymphoma/cancer cells of BIA-ALCL are usually found in the scar tissue/capsule and the fluid near the implant; in some cases, the cancer can spread throughout the body.

Breast implants are used in both cosmetic and reconstructive breast surgery. Most reconstructive breast surgery is for patients with breast cancer. Approximately 400,000 breast implants are placed in the United States every year. Approximately 75 percent of these are for cosmetic breast enlargement/enhancement and the remaining 25 percent for breast reconstruction. Both smooth and textured implants are used for both of these types of breast implant surgery.

“Symptoms of BIA-ALCL include persistent swelling or pain in the area of the breast implant. If you notice any changes in your breasts or have any concerns, you should be evaluated by your primary care provider,” says Bradley Coots, MD, plastic and reconstructive surgeon with Lift Plastic Surgery. “The FDA is not recommending removal of any breast implants in women who do not have symptoms. However, it is important to monitor your breasts for swelling or pain. It is also important to continue with annual exams with your primary care provider and to follow recommended guidelines to promote breast health such as mammograms.”

If patients are not sure if they have an Allergan BIOCELL textured breast implant, they can check the implant information card that they received at the time of implant placement, they can check their medical record from the hospital or clinic where they received care or they can call Lift Plastic Surgery for additional information.

Additional information about BIA-ALCL and breast implants can be found on the FDA website.

 



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