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FDA Reclassifies Vaginal Mesh Implants as ‘High-Risk’

Transvaginal mesh implants – also referred to as bladder mesh, bladder slings or vaginal mesh implants – have recently been reclassified by regulators at the U.S. Food and Drug Administration (FDA).

Once classified as a class II “moderate-risk” device, transvaginal mesh has been reclassified by regulators as a class III “high-risk” device due to growing evidence that the risks associated with these devices are significant and “not rare,” according to federal regulators.

Background on the Risks Linked to Transvaginal Mesh

Used in the treatment of pelvic organ prolapse (POP) and stress urinary incontinence (SUI), vaginal mesh implants are intended to provide extra support to the vaginal walls and abdominal organs when some trauma (including childbirth) has weakened these walls, adding pressure to women’s pelvic region.

As the FDA has pointed out, however:

Over the past several years, the FDA has seen a significant increase in the number of reported adverse events associated with the use of surgical mesh for transvaginal POP repair.

These reports of adverse events have specifically pertained to vaginal mesh complications that include (but may not be limited to):

  • Erosion of the mesh through the vaginal walls
  • Mesh puncturing the organs, tissues and/or blood vessels surrounding it
  • Recurrence of POP and/or SUI
  • Pain during intercourse
  • Increased infections
  • Vaginal scarring.

In fact, mounting reports of these injuries led FDA regulators to declare, in July 2011, that:

Serious complications associated with surgical mesh for transvaginal repair of POP are not rare… Furthermore, it is not clear that transvaginal POP repair with mesh is more effective than traditional non-mesh repair in all patients with POP and it may expose patients to greater risk.

Commenting on FDA’s recent reclassification of vaginal mesh implants , William Maisel, chief scientist for the FDA’s Center for Devices and Radiological Health, has noted that:

These stronger clinical requirements will help to address the significant risks associated with surgical mesh for repair of pelvic organ prolapse… We intend to continue monitoring how women with this device are faring months and years after surgery through continued postmarket surveillance measures.

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Contact Columbia SC Injury Attorneys at Chappell Smith & Arden, P.A. Attorneys at Law

If you have been harmed by a defective vaginal mesh device – or by any dangerous medical device or consumer product, contact Columbia SC injury attorneys at Chappell Smith & Arden, P.A. for clear answers about your rights and options for proceeding, as well as effective legal advocacy moving forward.

Call our firm at 866-881-8623 or email us via the contact form on this page to set up a free, no obligations initial consult with one of our lawyers. During this meeting, you can find out more about your rights, as well as how we can help you.

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