'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.
Brasil Últimas Notícias, Brasil Manchetes
Similar News:Você também pode ler notícias semelhantes a esta que coletamos de outras fontes de notícias.
Women, doctors speak about breast implant illnesses at FDA hearingThe FDA is reviewing the safety of breast implants used by millions of American women at a 2-day hearing about their long-term potential health effects.
Consulte Mais informação »
Sage Therapeutics’ Drug for Postpartum Depression Gets FDA NodU.S. health regulators on Tuesday approved Sage Therapeutics Inc.’s Zulresso, the first medication specifically intended for women with postpartum depression.
Consulte Mais informação »
FDA says cybersecurity vulnerabilities found in some Medtronic devicesThe U.S. Food and Drug Administration (FDA) on Thursday said cybersecurity vulne...
Consulte Mais informação »
FDA approves new device for treating patients with chronic heart failureThe Food and Drug Administration approved a breakthrough medical device last week for patients suffering from chronic, hard-to-treat heart failure.
Consulte Mais informação »
FDA takes up decades-long debate over breast implant safety
Consulte Mais informação »
FDA-approved 'breakthrough' heart failure device improves heart function in patients with late-stage diseaseA new device on the market for patients with heart failure is the first device in cardiology to receive a “breakthrough” designation by the Food and Drug Administration.
Consulte Mais informação »
Outgoing FDA chief: Altria bait-and-switched me with $12.8 billion Juul investmentFood and Drug Administration (FDA) Commissioner Scott Gottlieb said on Tuesday that tobacco giant Altria went back on its promise to clamp down on vape pods with its $12.8 billion investment in e-cigarette decacorn Juul Labs.
Consulte Mais informação »
Jazz Pharma's sleep disorder treatment gets FDA nodThe U.S. Food and Drug Administration approved Jazz Pharmaceuticals Plc's t...
Consulte Mais informação »
FDA approves first treatment for postpartum depressionThe FDA has approved a new medication called Zulresso, a completely new class of drug designed specifically to treat postpartum depression. It’s a one-time infusion given in a hospital over two and a half days.
Consulte Mais informação »