The FDA reported on Jan. 26, 2011 that women with breast implants have a small but slightly increased risk of developing anaplastic large cell lymphoma (ALCL), a very rare disease typically affecting 3 out of 100 million women. If you have breast implants but no symptoms, you should continue with routine follow ups with your medical providers and you should discuss the risks and benefits as they pertain to you. Read the full FDA news release here.
BCA has long advocated that we must stop putting products in the marketplace before we fully understand their potential impact on human health. In this case, the studies that identified that women with breast implants have a small but increased risk of ALCL were conducted in post approval monitoring – after approved implants were surgically placed in women’s bodies. BCA will continue to urge the FDA to put patients first and have health data before approving medical devices.