Endo International (NSDQ:ENDP) subsidiary American Medical Systems Holdings reportedly accused “a pyramid of businessmen, doctors and lawyers” of convincing women to undergo unnecessary surgeries to remove pelvic mesh implants and inflate their damage claims. AMS has set aside $1.9 billion to cover as many as 49,000 product liability lawsuits alleging injury from the devices. But the company […]
Women's Health
Smith & Nephew deals Truclear gynecology biz to Medtronic for $350m
Smith & Nephew (NYSE:SNN) said today that it’s dealing its gynecology business to Medtronic (NYSE:MDT), including the Truclear hysteroscopic resection and removal system, for $350 million. The London-based healthcare giant said the Truclear device put up sales of $56 million last year, or just more than 1% of total revenues. The proceeds will go toward a $300 million […]
Hologic launches new MyoSure Reach device
Hologic (NSDQ:HOLX) said today it is launching the MyoSure Reach device, designed to manage hard-to-Reach uterine pathology to access the upper third of the uterine cavity. The addition is an expansion of its already released MyoSure gynecological surgical products, the Marlborough, Mass.-based company said. The MyoSure tissue removal system is designed for the removal of polyps […]
C.R. Bard settles clutch of pelvic mesh lawsuits
A West Virginia federal judge yesterday dismissed nearly 150 product liability lawsuits brought against C.R. Bard (NYSE:BCR) over its pelvic mesh products, after an appeals court earlier this year upheld a $2 million verdict against the company in another suit. Judge Joseph Goodwin of the U.S. District Court for Southern West Virginia, who’s overseeing the multi-district […]
Hologic wins FDA nod for Affirm biopsy system, launches in US
Hologic (NSDQ:HOLX) said today it won FDA 510(k) clearance for its Affirm prone biopsy system and launched the platform in the U.S. The Affirm biopsy system is the 1st prone biopsy system to offer both 2D and 3D imaging-guided breast biopsies, the Marlborough, Mass.-based company claims. The device is designed to allow radiologists to target lesions […]
Viveve preps $12m offering ahead of NASDAQ uplisting
Viveve (OTC:VIVMD) said today that it’s planning to raise $11.5 million, having executed a 1-for-8 reverse stock split, as part of its uplisting from the over-the-counter exchange to the NASDAQ board. Sunnyvale, Calif.-based Viveve makes a non-surgical treatment for post-partum laxity of the vaginal introitus. The company put the reverse split into place yesterday; today Viveve said it plans to hit […]
Report: Feds impanel grand jury in Boston Scientific pelvic mesh probe
A federal probe into allegations that Boston Scientific (NYSE:BSX) used counterfeit resin to make pelvic mesh products has reportedly convened a grand jury in West Virginia that’s already sent out several subpoenas. The accusations 1st surfaced in January with the filing of a purported class-action racketeering lawsuit in the U.S. District Court for Southern West Virginia, the venue for multi-district […]
EmboMedics raises $4.3m for embolization microbeads
EmboMedics said it raised a $4.3 million Series A1 round for the bioresorbable embolization microspheres it’s developing. Maple Grove, Minn.-based EmboMedics said it plans to use the proceeds to pursue pre-market approval for a drug-delivery device, co-founder & CEO Omid Souresrafil said in prepared remarks. The infusion is enough to carry the company through 2018, Souresrafil said. […]
Johnson & Johnson’s $5m mesh settlement could push costs higher
Johnson & Johnson (NYSE:JNJ) subsidiary Ethicon could be facing a steeper-than-expected tab when it comes to settling the more than 46,000 product liability lawsuits brought over its pelvic mesh products, after details about 1 settlement became public in a legal filing. J&J agreed to pay $5 million to settle plaintiff Pamela Wicker’s lawsuit alleging that […]
Plaintiff’s lawyers ask FDA to ban Boston Scientific’s pelvic mesh
The law firm that’s bringing a racketeering lawsuit against Boston Scientific (NYSE:BSX) accusing it of smuggling counterfeit resin asked the FDA to ban the medical device maker’s pelvic mesh products made with the allegedly impure resin. Teresa Stevens sued Boston Scientific in January, alleging that the Marlborough, Mass.-based company conspired with subsidiaries in Belgium and Ireland to use counterfeit resin imported from China […]
FDA updates on Boston Scientific surgical mesh implant “counterfeit” material
The FDA today released an update on allegations that Boston Scientific‘s (NYSE:BSX) urogynecologic surgical mesh may contain counterfeit raw material. The agency said it was “examining these allegations” to determine the next steps, but said it is currently not away that the alleged counterfeit raw material is contributing to adverse events with the products. “It […]