What Is Transvaginal Mesh?
Transvaginal mesh (aka surgical or pelvic mesh) is primarily used to treat pelvic organ prolapse and stress urinary incontinence. The procedure involves using the net-like mesh to support weakened pelvic tissues. A surgeon makes an incision in the vaginal wall to insert the mesh and ideally, the patient’s tissue will later grow into the mesh holes to create a supportive wall. About 1 in 8 women has surgery to repair POP over her lifetime, according to the FDA.
Here are just a few of the most common transvaginal mesh manufacturers that may have been involved in these complication-laden surgeries:
- Boston Scientific
- Coloplast
- Johnson & Johnson
- C.R. Bard, Inc.
- Covidien
What Are Common Transvaginal Mesh Complications?
From 2005-2010, the FDA reported 3,979 reports of injury, death, and malfunction associated with urogynecological surgical mesh products. Other studies suggest that 1 in every 30 patients may need a second procedure to remove or revise the mesh, causing residual complications. Here are some of the most common as a result of a defective pelvic mesh:
- Chronic pain
- Mesh erosion
- Urinary issues
- Vaginal bleeding
- Organ perforation
- Ongoing infections
- Scar tissue formation
- Pain during intercourse
- Recurrence of pelvic organ prolapse or stress urinary incontinence
FDA’s Efforts to Address Vaginal Mesh Injuries
In past years, the FDA has worked to investigate and eliminate mesh as a treatment for pelvic organ prolapse (POP) due to evidence that the health risks of the procedure outweigh its initially proclaimed benefits. In effect, the many vaginal mesh injury claims pursued by injured patients have caused the government to take definitive action, and as of April 16, 2019, the FDA banned the use of vaginal mesh for POP treatment.
Here, you’ll find a summarized history of the studies done and regulations issued by the FDA to determine the safety (or lack thereof) of vaginal mesh:
- July 13, 2011: The FDA published a communication about the serious complications associated with transvaginal placement of surgical mesh used to treat POP.
- January 3, 2012: The FDA ordered 522 postmarket surveillance studies by manufacturers of surgical mesh devices to address specific safety and effectiveness concerns.
- February 12, 2019: The FDA hosted an advisory committee to discuss the safety and effectiveness of surgical mesh for transvaginal repair of prolapse with industry experts.
- April 16, 2019: The FDA orders the manufacturers of three vaginal mesh products on the market to stop selling and distributing their products.
How Do I Know Whether I’m Eligible to File a Transvaginal Mesh Lawsuit?
The typical candidate for a transvaginal mesh lawsuit is a woman who has experienced complications or injury after a transvaginal mesh implant. If you’ve had surgery for pelvic organ prolapse (POP) or stress urinary incontinence (SUI) and later suffered from complications, then you may be eligible to file a vaginal mesh lawsuit.
However, you must also demonstrate that the mesh was the direct cause of your complications. Maybe your defective device was removed following an infection, or your health was otherwise harmed after the mesh implant. You must also file your pelvic mesh lawsuit in compliance with the statute of limitations. Depending on your state, you’ll have between 1-6 years to file a claim after discovery of the injury.
Whatever your situation, a resourceful transvaginal mesh attorney can investigate your case through medical records, expert testimony, and previous cases involving the product used in your procedure. They’ll also help to determine your statute of limitations and do everything in their power to preserve your legal rights and bring your case to court on time.
How Can Transvaginal Mesh Lawyers at Simmons & Fletcher, P.C. Help?
An empathetic and diligent transvaginal mesh attorney from Simmons & Fletcher can support you legally and emotionally throughout your claims process. If hired onto your case, our hardworking legal team will gather evidence, file a claim, and negotiate settlements on your behalf. Our firm has been operating since 1979, fighting for injured parties and seeking justice. Contact us today for a free case review.