Urinary Incontinence: Mesh Slings Come Under Fire

Article preview from Medtech Insight - September 1, 2011

A large, undertreated patient population makes the urinary incontinence market an attractive arena for manufacturers; however, looming changes to the product approval process have added a level of uncertainty about future market growth.

Urinary Incontinence: Mesh Slings Come Under Fire

Article preview from Medtech Insight - September 1, 2011

Although modern medical technology provides treatments that are highly successful against urinary incontinence (UI), the condition remains largely undertreated. An estimated two-thirds of the UI population does not receive the proper medical attention, and now new concerns about safety could lead the US Food and Drug Administration (FDA) to increase approval requirements for one of the most popular forms of treatment. Specifically, the agency's concerns are with the use of mesh slings for women who suffer from stress urinary incontinence (SUI), one of the most common forms of UI, as well as pelvic organ prolapse (POP).

The safety issue is not a new concern as the FDA issued a Public Health Notification back in October 2008 cautioning physicians about serious complications associated with transvaginal placement of surgical mesh for POP and SUI. However in July of this year, after an updated review of the available data, the agency issued a new Safety Communication about mesh repair of POP, warning the medical community that adverse events are more frequent than was previously believed. The agency also cautioned that there is no clear evidence that transvaginal POP repair with mesh is more effective than traditional non-mesh repair. As a result of this new analysis, the FDA is considering whether to increase the regulatory requirements for these devices, which are currently approved via the 510(k) clearance route.

According to the FDA, the number of patient complaints about transvaginal mesh implants has been on the rise, with five times as many adverse event reports filed between 2008 and 2010 as compared to the previous two-year period.

Continued...

To read this article in its entirety, Purchase now as a PDF and receive it immediately via email. Or get it FREE when you subscribe to Medtech Insight Newsletter.

About Medtech Insight

Medtech Insight newsletter provides insights into the technology and market developments (devices, instrumentation, biomaterials, gene therapy, tissue engineering, etc.) impacting a wide range of surgical and non-surgical clinical practices.