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FDA Halts All Sales of Pelvic Mesh Products Tied to Injuries in Women

The U.S. Food and Drug Administration on Tuesday announced a ban on the sale of all pelvic mesh products.  The surgical mesh is typically used to repair pelvic organ prolapse (POP) and incontinence, but reported side effects have included permanent incontinence, severe discomfort and an inability to have sex.  “In order for these mesh devices to stay on the market, we determined that we needed evidence that they worked better than surgery without the use of mesh to repair POP,” said Dr. Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health. “That evidence was lacking in these premarket applications, and we couldn’t assure women that these devices were safe and effective long term.” Read more.

Source: HealthDay News, April 16, 2019

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Nurses Welcome NICE Support for Irrigation Device for Constipation and Faecal Incontinence

A medical device for treating constipation and faecal incontinence has been recommended for health service use by the National Institute for Health and Care Excellence.  Specialist stoma care nurses working with both children and adults affected by faecal continence problems welcomed the decision by NICE to back the use of the Peristeen transanal irrigation system.In new medical technology guidance published today, NICE said the “case for adopting” the Peristeen for managing bowel dysfunction was “supported by the evidence”.  According to NICE, the system can “reduce the severity of constipation and incontinence, improve quality of life and promote dignity and independence”.  Read more.

Source: Nursing Times, February 23, 2018