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FDA sets new rules

Pelvic mesh falls under scrutiny

WASHINGTON — Mesh implants used to repair pelvic collapse in women will face new federal scrutiny, under rules responding to thousands of injuries reported with the problem-prone devices.

The Food and Drug Administration said Monday makers of pelvic mesh must submit new applications demonstrating the safety and effectiveness of their products.

The change follows years of reports of pain, bleeding and infection among women receiving the implants.

Those complications sometimes require multiple surgeries to remove or reposition the mesh.

The new requirements do not apply to mesh products when used to treat other conditions such as hernias or urinary incontinence.

The FDA action comes more than four years after the agency concluded that women getting vaginal mesh have more complications than women who undergo traditional surgery with stitches.

Mesh products were introduced for pelvic repair in the 1990s and promoted as a way to speed patients’ recovery time.

But FDA advisers said those benefits have not been established.

Patients have filed tens of thousands of lawsuits against mesh manufacturers, including Johnson & Johnson, Boston Scientific and Endo International.

In 2014, Ireland-based Endo said it would pay $830 million to settle more than 20,000 personal injury lawsuits.

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