Devices

Safety Alert on Silicone Marketed as Body Contouring Product

FDA has issued a safety alert about illegal use of injectable silicone for body contouring and associated injuries and disfigurement that can result from such products. The agency says the injectable silicone products are being falsely marketed as FDA-approved dermal fillers for the purpose of enhancing the size of their buttocks, breasts and other body parts.

“We’ve seen serious adverse events result from products, which are sometimes industrial-grade silicone, being used for these unapproved medical purposes,” FDA commissioner Scott Gottlieb is quoted in a release as saying. “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. While we’ll continue to go after those who provide these unlawful services, the FDA will have its greatest impact by educating Americans to avoid these unsafe practices.”

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

Read more

Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome