Device Safety

Latest Headlines

Latest Headlines

Boston Sci gets bad news on four of 23,000+ vaginal mesh lawsuits

Boston Scientific faces more than 23,000 lawsuits over its Pinnacle transvaginal mesh device. Last week it failed to remove four cases from a consolidated multidistrict litigation suit in the U.S. District Court for Western Virginia.

FDA allows Covidien to restart manufacturing of two recalled devices

The FDA approved Covidien's fixes to the manufacturing process of its recalled Pipeline Embolization Device and Alligator Retrieval Device for treating brain aneurysms.

NY Senators tell FDA to stop sales of power morcellators

Democratic Sens. Chuck Schumer and Kirsten Gillibrand of New York urged the FDA to remove all power morcellators from the market in a letter to FDA Commissioner Margaret Hamburg.

FDA targets off-label use of intranasal splint, with safety alert and Class I recall notice

The FDA continued its attack on Enhancement Medical LLC's Expression intranasal splint, designating the product's July recall as Class I.

Home healthcare design considerations addressed in FDA final guidance

The migration of medical devices to the home poses new and unique challenges, prompting the FDA to finalize its guidance on design considerations for devices intended for home use (or "home healthcare"), issued today.

Ablatherm ultrasound prostate cancer treatment rebuffed by FDA panel

The FDA's Gastroenterology & Urology Devices panel came down firmly against EDAP's Ablatherm system for treating low-risk, localized prostate cancer. The panel voted 9-0 on the device's effectiveness, 5-3 against its safety (with one abstention) and said the risks outweigh the benefits by a vote of 8-0 (with one abstention).

Johnson & Johnson pulls power morcellator devices amid industry and regulatory backlash

Amid regulatory and industry backlash surrounding the use of laparoscopic surgical tools in gynecological procedures, Johnson & Johnson is pulling its related device from the global market.

Boston Scientific wins first vaginal mesh case to go to trial

Boston Scientific scored a victory in its ongoing transvaginal mesh saga, winning the first case to go to trial in Massachusetts state court.

Registry data shows high risk of blood clot among users of Abbott's bioresorbable stent

Data from a European postmarket registry show that Abbott's Absorb BVS bioresorbable stent performs at a level similar to today's conventional drug-eluting stents on several measures, but not stent thrombosis. The risk of the stent being blocked by a blood clot was 3.4% after one year, a level of performance similar to prior generation drug-eluting stents, according to a recent EuroIntervention study.

Upcoming study to dispute FDA's data on power morcellation risk

Dr. Elizabeth Pritts, director of the Wisconsin Fertility Institute, believes that the FDA is wildly overestimating the prevalence of uterine sarcoma in women undergoing hysterectomies and myomectomies for fibroid removal and worries that banning or restricting use of power morcellators will fail to address the problem, putting women undergoing the procedure at risk of upstaged cancer.