Devices

Petition Against BD’s Breast Reconstruction Device

Former Becton Dickinson (BD) medical director Hooman Noorchashm has petitioned FDA to “scrutinize” the company’s 2017 510(k) clearance for the GalaForm 3D due to label misrepresentations and “fraud on FDA.” Noorchashm’s petition alleges that BD “deliberately failed to reveal its true design to market and distribute the device primarily as an ‘internal bra’ for breast reconstruction surgeries. Furthermore, the manufacturer also deliberately or negligently failed to inform FDA or consumers/patients about a potential oncogenic safety concern regarding the ‘P4HB’ material used to manufacture its GalaFlex products.”

Cardiac surgeon Noorchashm is best known to FDA for his opposition to power morcellation. He previously alleged his BD employment was terminated in 8/2022 after he continually objected to the company’s alleged practice of not reporting device defects to the agency.

In the petition, Noorchashm argues that despite BD’s intentional design of the mesh product for breast reconstruction, “nowhere in the 510(k) application did the … applicant make mention of its very specific intent to target GalaGlex 3DR to the tightly regulated clinical breast surgery space.”

Additionally, the petition asserts that because BD knew the device would be used in breast surgeries and it has “aggressively” promoted it off-label, then the company should have sought an expanded label for such use.

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