FDA Warns Surgical Mesh in Breast Implants Could Pose Greater Risks
Medical device manufacturer Allergan is recalling its textured breast implants that have been linked to a rare form of cancer. According to a report in The New York Times, the implants are being recalled worldwide at the request of the U.S. Food and Drug Administration (FDA), which oversees medical device manufacturers.
Cancer Cases and Deaths
So far, worldwide, 573 cases and 33 deaths from cancer have been reported with 481 of the cases clearly attributed to Allergan textured breast implants, the FDA said. Of the 33 deaths, the agency said the data it had collected showed that the type of implant was known in 13 cases, and in 12 of those cases, Allergan made the implants. Women who have these implants, but don’t have symptoms, don’t need to have them removed, the FDA said.
This recall means that doctors and hospitals should not implant any more of these devices, and are required to return any on their shelves to Allergan. The recalled devices include Biocell products including Natrelle Saline-Filled breast implants, Natrelle Silicone-Filled breast implants, Natrelle Inspira Silicone-Filled breast implants, and Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Filled breast implants. This recall also includes tissue expanders used by patients before breast augmentation or reconstruction.
Link to Anaplastic Large-Cell Lymphoma
The cancer that has been linked to these implants is anaplastic large-cell lymphoma, a rare cancer of the immune system. Even though this is not breast cancer, it develops in the tissue around the implant. When the cancer is not detected early, it can spread to the rest of the body and prove fatal. This type of lymphoma has occurred both in women who received the implant for cosmetic breast enlargement and in women who got them for reconstruction after mastectomy for breast cancer.
The most common symptom of lymphoma is swelling around the implant. If this occurs, the fluid should be drained and tested for cancer. Textured implants have been singled out as the cause of lymphoma. A vast number of cases have involved Allergan products. Textured breast implants have already been removed from a number of European markets and in Canada because of the rise in lymphoma cases and deaths.
If you or a loved one has been diagnosed with anaplastic large-cell lymphoma as a result of receiving textured breast implants, you may be able to file a product liability lawsuit against the manufacturer seeking compensation for your injuries, damages and losses. If you have lost a loved one to cancer as a result of these products, you may be able to file a wrongful death lawsuit seeking compensation. An experienced product defect lawyer will be able to guide you through the process and help you secure maximum compensation for your losses.