FDA May Add New Warnings to Breast Implant Products
The U.S. Food and Drug Administration (FDA) recently announced that it is considering new labeling recommendations for breast implants that will help patients better understand the risks of the product and the surgical procedures involved.
In a press release, the agency indicated that it has heard from many women who said they weren’t fully informed of the risks associated with the cosmetic procedure or the implants themselves. The agency said that adding a boxed warning—the strictest of the agency’s warnings— and a patient checklist could help women make more informed decisions before opting to have the procedure.
If approved and implemented, the boxed warning would include information about breast implants not being permanent lifetime devices as well as information about their potential risks, including the likelihood of developing complications long after surgery. In some cases, patients with complications require revision surgeries.
The FDA also indicated that breast implants may be associated with an increased risk of developing a type of cancer called anaplastic large cell lymphoma in addition to systemic symptoms like fatigue or joint pain. Also included in the patient checklist and warnings would be information about the risk of rupture for patients with silicone gel-filled implants, which would include either an ultrasound or MRI every five to six years after initially receiving the implants.
At Ferrer, Poirot & Wansbrough, our defective medical device lawyers know that any medical device that’s implanted into the body, whether it’s for medical or cosmetic purposes, carries risks. It’s our goal to help people when they are injured through the actions of negligent medical product manufacturers. If you or someone you love was hurt by a medical device, we want to help. Contact us today for a free consultation.