Devices

FDA OKs Mentor's Larger Breast Implants

FDA has approved a Mentor Worldwide PMA for its MemoryGel Enhance Breast Implants for primary and revision reconstruction breast surgery in women. The silicone gel-filled implant line “features an expanded range of base widths, projections, and volumes in an entirely new range of sizes extending from 930 cc to 1,445 cc, the largest on the market,” the company says.

An increasing number of patients are requiring larger breast due to factors such as body frame, breast size, or extensive tissue removal during mastectomy, according to Mentor. “Previously, women with larger cup sizes faced limitations to their breast reconstruction options as the largest implant available was 800 cc,” it says.

Approval is based on data from the ongoing 10-year ATHENA study, “which demonstrated the safety and effectiveness of MemoryGel Enhance larger-volume silicone breast implants after three years, in women who underwent post mastectomy and implant-based breast reconstruction,” the company says.

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