Devices

Soft Tissue Filler Approvals Can be Strengthened: Researchers

Researchers from Northwestern University and the University of Chicago say that soft tissue fillers (STFs) are safe and are often approved as Class 3 medical devices based on data from randomized clinical trials. However, they write in JAMA Facial Plastic Surgery, “an opportunity remains to strengthen the approval process, particularly through multispecialty engagement to strengthen the approval process.”

The report notes that STF injections are the second most common nonsurgical cosmetic procedure in the U.S., preceded only by botulinum toxin injections. It references a 5/2015 FDA safety communication highlighting reported complications of STFs, including vision impairment, blindness, stoke, and death of skin and facial structures.

The researchers evaluated 14 STF approvals that had 10 pivotal studies as randomized clinical trials and nine that were masked. The median number of patients per trial was 144.

They conclude that safety warnings relate more to the off-label use of STFs, which they say has not been sufficiently studied prospectively. Approvals could be strengthened, they write, through implementation of unique device identifiers and greater use of physician-led registries. They say those changes would lead to physician, consumer, and regulatory confidence in STF safety.

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

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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