The first transvaginal mesh entered the market in 1996 when Boston Scientific released its ProteGen bladder sling to help women suffering from stress urinary incontinence (SUI) and pelvic organ prolapse (POP). The product was recalled in 1999 after reports of complications with the mesh.
What Is the Problem?
Boston Scientific was able to fast-track the approval process for the transvaginal mesh by submitting a Premarket Notification 510(k) to the FDA. A Premarket Notification 510(k) explains that the product is similar to an existing product that already went through FDA approval. This 510(k) process expedites the process to get the product on the market because the pharmaceutical company does not have to pay for clinical trials to test the drug or device.
Boston Scientific claimed that the ProteGen bladder sling was equivalent to hernia meshes already on the market, including Trelex Natural Mesh and Gore-Tex Soft Tissue Patch.
What Are the Injuries?
Similar to hernia mesh complications, transvaginal meshes can cause mesh migration, infection, chronic pain, and mesh erosion. Because of the 510(k) process, transvaginal meshes were not tested in a vagina before they entered the market. One of the downsides of the 510(k) process is that it allows the flaw in the equivalent products to be used in the product.
The injuries associated with a transvaginal mesh include:
- Mesh erosion
- Painful sexual intercourse
- Pelvic and vaginal pain
- Urinary leakage
Perforation of bladder, intestines or bowels
Goldenberg Lauricella Can Help
Goldenberg Lauricella is committed to promoting safety through accountability. If you or a loved one suffered from a transvaginal mesh implantation, contact us for a free case evaluation. Goldenberg Lauricella has over 30 years of experience in defective drug and device litigation. Call us. You will sleep better.