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Latest From Coloplast AS

Boston Scientific Pays $189M To Resolve Pelvic Mesh Cases

The settlement puts to rest product liability and patient safety suits in 47 states and the District of Columbia.

Legal Issues Regulation

Top 100 Review: The Calm Before The Storm – But Some Medtechs Already Reflect The Ravages Of COVID-19

2019 saw fewer revenues-boosting major acquisitions by top-tier medtechs. Companies that reported after the calendar year-end were the first to see the consequences of the pandemic on their annual figures.

Commercial Sales & Earnings

Study Says FDA Waited Too Long To Ban Pelvic Mesh For POP Repairs

Roughly 18.5% of patients who received reinterventions to fix mesh implants for pelvic organ prolapse (POP) repair experienced complications they will likely endure for the rest of their lives, and they also face a 2.5% higher rate of further surgeries than non-mesh patients, says a recent 54,194-woman study detailed in Obstetrics & Gynecology. The study authors lay out a case that the US FDA should have forced removal of mesh from the market sooner.

Regulation FDA

FDA Yanks Transvaginal Mesh From US Market; Boston Sci 'Surprised'; Firms Have 10 Days To Submit Withdraw Plan

Transvaginal mesh products made by Boston Scientific and Coloplast were ordered pulled from US shelves by the agency on Aug. 16. Under the rare FDA order, the two firms must immediately stop selling the mesh and have 10 days to submit plans to the agency outlining how they will recall their unimplanted devices.

Recalls FDA
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