'I was not warned': Women who say they were sickened by breast implants demand FDA action
U.S. health officials are taking another look at the safety of breast implants, including the silicone breast implants pictured here.
The FDA said recently it is taking a closer look at implants, which have sparked anger and contention for decades. The agency asked its General and Plastic Surgery Devices Advisory Committee for recommendations on a raft of issues, and Cook’s testimony was part of a two-day hearing, which continues Tuesday, on the key issues.
Anastasia Allmendinger, a 53-year-old resident of Newport News, Va., said that she got implants in 2010 and years later was diagnosed with the cancer, called anaplastic large cell lymphoma, or ALCL. She underwent surgery to remove the implants, chemotherapy and a stem-cell transplant, and is now doing well, but said that manufacturers should be held accountable for the illnesses and women should be better informed. Experts say that many patients can be successfully treated only with surgery.
On the other main illness of concern -- the one linked to autoimmune and connective-tissue disease -- the FDA and the patient community have long been at odds. The FDA immediately expressed skepticism, saying the study was flawed. But Binita Ashar, the agency’s director of surgical devices at the FDA’s Center for Devices and Radiological Health, also said the agency is stepping up its long-term surveillance of implants and using patient registries to track complications from the devices.
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