Latest News: Biocell Textured Implants Recalled
On July 24, the breast implant manufacturer Allergan issued a voluntary withdrawal of its Biocell TEXTURED SURFACE silicone gel filled and saline filled breast implants from the market. Allergan issued the recall due to this aggressively textured implant’s association with a very rare form of cancer called Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA-ALCL). The recall does not involve implants manufactured by Mentor, Sientra, or Ideal.
BIA-ALCL is not breast cancer. It is an extremely rare, very treatable type of non-Hodgkin’s lymphoma that can develop around breast implants. To date, 288 cases have been reported in the United Sates – no cases of ALCL have been reported in Arkansas. There have been no confirmed cases of BIA-ALCL in women who have had only SMOOTH SURFACE breast implants.
Due to the low risk of developing BIA-ALCL, the FDA does NOT recommend that women with these implants have them removed unless they are experiencing symptoms. The most common symptom is a collection of fluid around the implant or significant swelling of one breast. Symptoms may also include pain, a breast lump, swollen lymph node in the armpit, rash, fever, weight-loss, change in breast shape, or asymmetry.
If you are experiencing any of these symptoms, please contact my office, (501) 224-1300. I will perform an evaluation and determine if any testing or treatment is indicated. I stopped using these recalled implants in 2011 for other reasons, and only used them in a few patients.
Women who develop BIA-ALCL are almost always cured by removing the implant and the scar tissue surrounding it. Some patients may require additional treatment.
For additional information about BIA-ALCL, the website of the American Society of Plastic Surgeons offers a great deal of information for patients. Of course, I will also make myself available to personally answer any of your questions and concerns.
Gene Sloan, MD, FACS
