Transvaginal Mesh Officially Reclassified as a Dangerous Medical Product

Right now, there are thousands of women across the country embroiled in defective product lawsuits over a product called transvaginal mesh, or TVM. Originally designed to fix hernias, TVM has been used primarily to fix pelvic organ prolapse (POP) and stress urinary incontinence (SUI), two conditions common to older women who have given birth or had a hysterectomy. As it turns out, TVM can cause serious, even life-threatening medical conditions.

The Food and Drug Administration has been examining the potential dangers of transvaginal mesh since 2008, and recently issued two orders that puts the debate to rest. One of those orders was the reclassification of transvaginal mesh when used for POP procedures (though not in regards to SUI) from a Class II device, meaning it presented a moderate risk, to a Class III device, meaning it poses a high risk of complications. This is a tremendous step forward in the fight against Big Pharma, because it gives further support to all those women whose lives were irreparably changed because of a defective product.

The dangers associated with transvaginal mesh

TVM does not affect all women equally. Some have had procedures to fix their POP or SUI and experienced no side effects at all. But that does not leave manufacturers off the hook, so to speak. Transvaginal mesh is a dangerous product with debilitating side effects, and women who were not warned about those side effects may have a legal claim to compensation as well.

Just how bad is TVM? The complications can include:

• Severe pain
• Excessive bleeding
• Permanent scarring
• Difficulties performing intercourse
• Erosion of the materials, leading to
  • The spread of infection
  • Perforated regains, such as the bowel, urethra, rectum and bladder
• Infections spreading throughout the body

Many patients also had to undergo revision surgery, either to correct the problem or remove the mesh. Revision surgeries are dangerous – all surgery is – and often are not covered by insurance.

Why the FDA’s orders are so important

The new classification proves that TVM is a dangerous product – a fact backed up by the second of the two orders. Along with the reclassification, the FDA is now requiring all manufacturers of existing and new transvaginal mesh products to submit a “premarket approval (PMA) application to support the safety and effectiveness of surgical mesh.” New products cannot be approved for marketing unless a PMA is submitted beforehand. Existing products must be given a PMA within the next 30 months, or risk losing their shelf space.

This is a huge win for injured women in South Carolina and through the country. It may also open the door for more women to make claims if they were injured or left unaware of the dangers, now and in the future.

McGowan, Hood, Felder & Phillips, LLC, is one of South Carolina’s premier mass tort and defective product litigation law firms. Our skilled attorneys have the experience and resources to handle complex claims like those involving transvaginal mesh. If you or your loved one suffered serious complications as a result of a procedure that sued TVM, we encourage you to contact us today to find out more about your options.