Five medical device companies that make pelvic mesh implants are hoping to negotiate settlements for the more than 30,000 pending lawsuits they’re facing in the U.S., anonymous sources told Bloomberg.
Australian healthcare regulators issued a safety advisory late last month on certain lots of American Medical Systems’ AMS 800 urinary control systems, warning that the devices were released on the market on the market without meeting the company’s product release criteria.
American Medical Systems Europe BV recalled certain lots of its AdVance Male Sling Systems, warning that the absorbable sutures in the AdVance sling might not last as long as expected on the shelf.
Across the medical device industry, R&D spending in 2011 increased despite a lethargic economy, job cuts and reorganization mandates by a number of big-name companies.
The FDA’s medical device review process is again under scrutiny as lawsuits pile up against health care leviathan Johnson & Johnson (NYSE:JNJ) for transvaginal mesh devices that may do more harm than good.
Lawsuits claiming negligence against mesh-makers have also implicated the FDA’s review system for continuing to clear new mesh products under the 510(k) system, despite the predicate device being pulled from U.S. shelves.