[ing] two final orders to manufacturers and the public to strengthen the data requirements for surgical mesh to repair pelvic organ prolapse (POP) transvaginally.”

The first order reclassified TVM as a class III medical device, which indicates its potential as a high-risk device. The second one “requires manufacturers to submit a premarket approval (PMA) application to support the safety and effectiveness of surgical mesh for the transvaginal repair of POP,” according to the FDA. Any manufacturers who already have a mesh product on the market will have 30 months to submit their PMAs. New products must have a PMA submitted before gaining approval to market the devices.

This is a huge development – one that could bode well for the thousands of women who have filed lawsuits across the country. TVM has been associated with a variety of complications, including but not limited to:

• Organ perforation. The materials of the mesh have been known to puncture the urethra, bowel, bladder and rectum. This perforation can occur during the implanting of the mesh or over time.
• The materials that make most TVM products were originally approved only for fixing hernias. An unintended result is that those materials can erode over time. This is was usually leads to the organ perforation.
• Secondary surgeries. For many women, the only option is to remove the defective mesh. This necessitates a second surgery – which may or may not be covered by insurance – and opens a women up to additional risks. When the mesh fails to perform as expected – i.e., when it doesn’t work at all – a woman many need to undergo another surgery because the POP or urinary incontinence was never fixed.
• Women with defective transvaginal mesh are susceptible for infections, either from the perforation of the mesh or in the form of a urinary tract infection.
• Severe pain and discomfort. Bleeding, pain, bruising and nerve damage are just a few of the side effects mesh users have experienced. In some cases, the scarring inside the patient is so severe, it can cause extreme discomfort during sex as well.

The reclassification of transvaginal mesh is good news for women who are considering surgery as a way to fix their pelvic organ prolapse or urinary incontinence. It will force doctors to have a more frank discussion about the dangers associated with the device, and hopefully stop pharmaceutical manufacturers from producing dangerous, defective medical devices by hitting them where it hurts the most – their wallets.

If you or your loved one has suffered because of defective transvaginal mesh, the Delius & McKenzie, PLLC may be able to help. Please contact us to schedule a free consultation with an experienced Sevierville products liability attorney today. We proudly fight on behalf of the injured throughout Tennessee, including those in Pigeon Forge and Gatlinburg.