Devices

Petition Rejected on New Warnings for Surgical Mesh

FDA has denied a citizen petition requesting that it warn patients about whether surgical mesh implanted off-label during cosmetic mastopexy procedures may interfere with breast cancer detection using mammography or ultrasound. In an 11/14 denial letter, FDA said it has found no evidence of a safety signal linking absorbable or permanent mesh devices to reduced imaging sensitivity for breast cancer based on its medical device postmarket surveillance system. The 11/2023 petition was submitted by cardiac surgeon Hooman Noorchashm, known to FDA for his opposition to power morcellation.

The petition cited several case reports and a published clinical study suggesting that mesh implants could obscure images or create artifacts, potentially complicating cancer screening. FDA said it reviewed the cited materials but concluded that they do not raise new safety concerns beyond imaging challenges already known for breast implants and certain surgical materials.

The petitioner also asked the agency to determine whether patients receiving mesh off-label in cosmetic breast lifts are being adequately warned about possible imaging interference. FDA rejected the request, clarifying that citizen petitions cannot be used to compel the agency to conduct investigations or fact-finding beyond the existing administrative record. Under FDA regulations, citizen petitions may request regulatory or administrative actions—not investigations, it said.

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