Devices

Boston Scientific Stress Incontinence Warnings

Two new warnings are included among revisions Boston Scientific has made to the directions for use for six stress urinary incontinence products. A company announcement says that the first warning states that mesh is considered a permanent implant and removal of mesh or correction of mesh-related complications may involve multiple surgeries. The second warning is that complete removal of mesh may not be possible and additional surgeries may not always fully correct complications.

Two new precautions added to the directions discuss an association of the use of polypropylene mesh in urogynecologic procedures with cases of erosion, and a listing of risk factors that can affect patient outcomes in the pelvic floor.

The company says the revisions are to “enhance patient and physician information regarding the use of our devices and to provide … comprehensive information based on published literature and post-market data.”

Earlier this year, a petition asked FDA to order a recall of the company’s surgical mesh products because they are allegedly made from defective, counterfeit materials from China. Also, shortly after FDA 1/2016 reclassified surgical mesh indicated for pelvic organ prolapse to Class 3 and told manufacturers to submit safety-documented PMAs, an activist claiming to represent thousands of injured women urged that the products be recalled, claiming that the reclassification wasn’t sufficient. The activist said FDA should have included stress urinary incontinence in the reclassification.

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