Devices

Petition Seeks FDA Recall Order on Boston Scientific Surgical Mesh

Houston-based Mostyn Law has petitioned FDA asking that it order a recall of Boston Scientific’s surgical mesh products because they are allegedly made of defective, counterfeit material from China. The petition, filed on behalf of a West Virginia woman who suffered health problems from a Boston Scientific pelvic mesh implant, accuses the company of smuggling from China more than 34,000 pounds of unverified synthetic resin to make the mesh. It cites internal Boston Scientific emails that say the company bought the resin stock in 2011 and 2012 from a suspected counterfeiter in China without fully testing it or getting FDA approval for its use as a vaginal implant.

Earlier this year, a class action suit was filed in West Virginia federal court making similar allegations. The suit contains charges under the Racketeering and Corrupt Organizations Act (RICO) on behalf of women who have suffered severe discomfort, bleeding, infections, painful intercourse, urinary problems, and other complications from the mesh implants.

Also, FDA recently reclassified from Class 2 to Class 3 surgical mesh to repair pelvic organ prolapse (POP) transvaginally. The agency also required these product manufacturers to now submit a PMA to support their device’s safety and effectiveness. “The orders will require manufacturers to address safety concerns, including severe pelvic pain and organ perforation, through a rigorous PMA pathway to demonstrate safety and effectiveness,” an agency notice said. The actions do not apply to surgical mesh for other indications, like stress urinary incontinence or abdominal repair of POP, 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