Devices

Ethicon $10 Million Settlement Over Surgical Mesh

Johnson & Johnson’s Ethicon unit has reached an almost $10 million settlement agreement with Kentucky over alleged deceptive marketing practices involving the company’s pelvic mesh surgical devices. Under the terms of the agreement, Ethicon agreed to pay Kentucky $9.9 million within 30 days.

“Patients suffer when medical device manufacturers, like Ethicon, fail to provide accurate information to healthcare providers and patients about the risks associated with their products,” Kentucky attorney general Daniel Cameron is quoted in a release as saying. The settlement resolves allegations that Ethicon “violated the Kentucky Consumer Protection Act by misrepresenting or failing to adequately disclose serious and life-altering risks of surgical mesh devices when marketing the product to doctors, as required by the (FDA),” he says. “Risks such as chronic pain, scarring, painful sexual intercourse, and other complications were allegedly omitted from the products’ instructions for use.”

Surgical mesh is permanently implanted in the pelvic floor through the vagina to treat pelvic organ prolapse and stress urinary incontinence. “Before the filing of this lawsuit, more than 15,000 Kentucky women had been implanted with Ethicon’s transvaginal mesh devices,” the state says, adding that many have complained about serious complications due to the devices.

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