Beware of Illegal Breast and Butt Implants

FDA is cracking down on illegal products intended to boost the size of a person's breasts, butt, or other body parts. “We have significant concerns with unsafe injectable silicone that’s being marketed for body contouring by unlicensed providers. We’ve seen serious adverse events result from products, which are sometimes industrial-grade silicone, being used for these unapproved medical purposes,” said FDA Commissioner Scott Gottlieb, MD. “The FDA has stepped in to take enforcement actions against unscrupulous actors who promote and provide these services, but we also want to make the public aware of the risks, which can include irreversible disfigurement and even death." Gottlieb said the agency will continue to go after providers of these unlawful services, but he said public education will be where FDA has its greatest impact on this problem. Injectable silicone is different from the silicone contained within approved breast implants, FDA said, because the breast implant shell keeps the silicone from migrating within the body. Injectable silicone is currently only approved by FDA for intraocular ophthalmic use. When seeking breast, buttocks, other large-scale body contouring procedures, some consumers are falsely told they are receiving an FDA-approved dermal filler, but are actually injected with silicone. Side effects of these illegal procedures include pain, scarring, tissue death, and permanent disfigurement. If the silicone migrates beyond the injection site...
Source: MDDI - Category: Medical Devices Authors: Tags: Regulatory and Compliance Source Type: news