A plaintiff purporting to represent Boston Scientific shareholders sued the company yesterday, alleging that it misled investors about the prospects for its pelvic mesh products ahead of an FDA order to halt all U.S. sales of the devices. Last week the FDA ordered an immediate halt to sales and distribution of Boston’s Uphold Lite and Xenform products; […]
Plaintiff wins $120m in latest pelvic mesh trial against Johnson & Johnson unit
A state court jury in Philadelphia reportedly slapped Johnson & Johnson (NYSE:JNJ) subsidiary Ethicon with a $120 million verdict yesterday in a product liability lawsuit brought over one of its pelvic mesh products. The jury in the Pennsylvania Court of Common pleas awarded Susan McFarland $20 million in compensatory damages and $100 million in punitive damages after […]
Johnson & Johnson settles Washington AG’s pelvic mesh suit for $10m
Johnson & Johnson (NYSE:JNJ) has agreed to pay $9.9 million to settle a suit it faced from Washington Attorney General Bob Ferguson over a failure to include serious risks in instructions and marketing materials for surgical mesh devices, according to a Washington State Office of the Attorney General release. Approximately 14,000 women in Washington State have […]
Appeals court hands Hologic a loss in patent spat with Minerva Surgical
The U.S. Court of Appeals for the Federal Circuit today ruled against Hologic (NSDQ:HOLX) in a patent spat with Minerva Surgical, upholding a ruling from the U.S. Patent Trial and Appeal Board that claims on a patent Hologic owns, related to detecting perforations in body cavities during ablation, are unpatentable as obvious. In the case, Minerva […]
FDA’s pelvic mesh ban spooks investors
The FDA’s ban on U.S. sales of pelvic mesh products for pelvic organ prolapse may have spooked investors, but should only have a minimal effect on the books at Boston Scientific (NYSE:BSX) and Coloplast (CPH:COLO-B) – the only companies still selling mesh for prolapse in the U.S. – according to analysts and the company. Yesterday the […]
FDA bans Boston Sci, Coloplast sales of pelvic mesh
The FDA has ordered Boston Scientific (NYSE:BSX) and Coloplast — the only remaining companies that sell pelvic mesh in the U.S. — to immediately halt sales and distribution of those products. The two companies have not demonstrated a “reasonable assurance of safety and effectiveness for these devices” used to treat pelvic organ prolapse (POP) since the […]
More device shortages pegged to sterilization plant shutdown
More medtech companies are experiencing shortages of medical devices due to the sudden closure in February of a Sterigenics sterilization plant. Officials from Cardinal Health (NYSE:CAH), and Guerbet (EPA:GBT) have written letters to customers indicating that certain devices are already in short supply or may experience shortages, Medical Device & Outsourcing has learned. The letter from Cardinal Health (Dublin, […]
Australia’s TGA considering, but not yet implementing, textured breast implant ban
Australia’s TGA said yesterday that it is seeking new data from suppliers of textured breast implants, which have been linked to a rare immune-system cancer, before making a decision on whether or not to suspend or cancel those products from its Register of Therapeutic Goods. The regulatory body gave suppliers of the devices 10 working […]
AirXpanders touts study results
AirXpanders (ASX:AXP) said that a retrospective clinical study has concluded that the use of its AeroForm tissue expanders may be associated with reduced infection rates, less medical treatment and lower costs for patients and health systems. The Palo Alto-based company makes the AeroForm tissue expander for post-mastectomy breast reconstruction. The device is designed to expand and […]
Health Canada notifies Allergan on intent to suspend Biocell breast implant license
Health Canada said yesterday that it plans to suspend Allergan‘s (NYSE: AGN) licenses to sell its Biocell breast implants in the region due to a possible association with a rare immune system-cancer. The move follows the agency’s completion of a scientific assessment of macro-textured implants, which it said is part of a larger safety review of […]
Report: France to ban textured breast implants
France is planning to ban textured breast implants, which have been linked a rare immune-system cancer, according to a report from France24. France’s National Agency for Medicines and Health Products began informing manufacturers on April 2 of its plans to ban manufacturing, distribution, importing, exporting, promotion and wearing of textured breast implants and polyurethane breast […]
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