Tyco was one of the many medical device manufacturers that designed and received FDA approval for transvaginal mesh sling devices through the 510(k) process. Unlike other FDA approval processes, a product that receives an FDA 510(k) clearance does not require any clinical data substantiating the product’s effectiveness and safety. Without any clinical trials, doctors and patients had no available information regarding the potential dangers and complications associated with transvaginal mesh implants such as the Tyco IVS Tunneller.
Defective by Design
The Tyco IVS Tunneller and similar vaginal slings are used to help patients suffering from pelvic organ prolapse (POP). The surgical mesh devices are implanted transvaginally and positioned to reinforce the weakened vaginal wall, or in procedures treating stress urinary incontinence, support the urethra. Although many doctors performed urogynecological surgeries using transvaginal mesh devices, the FDA released a statement in 2011 warning doctors and surgeons that the use of a mesh in POP surgeries increased risks of complication while having no symptomatic benefits over traditional non-mesh operations. Mesh erosion or contraction was the most frequently cited cause of complication in all of the FDA adverse events reports.
FDA Investigations and Conclusion
Over the course of five years, between 2005 and 2010, the FDA received more than 4,000 adverse event reports related to transvaginal mesh implants, causing the FDA to initiate a thorough review of all the published scientific literature to evaluate the safety and effectiveness of the treatment. The findings of this literature review include:
- Use of surgical mesh in a urogynecological surgery introduces complications not present in non-mesh surgeries
- Although mesh augmentation has anatomic benefits, this does not necessarily produce better results
- There is no evidence demonstrating that transvaginal mesh surgeries are more effective than traditional surgeries
- Mesh erosion through the vagina is the leading cause of mesh-related complication reported by patients who received transvaginal mesh POP operations
Tyco IVS Transvaginal Mesh Device Lawsuits
Several transvaginal mesh device manufacturers, including Tyco, are facing lawsuits filed by patients who suffered severe complications due to mesh failure. Women who experience complications from a failed vaginal sling often require revision surgery to remove the defective device. In some cases, even with multiple excision surgery, the mesh may not be completely removed, leaving patients facing permanent pain and disability. Tyco IVS mesh patients in particular may be at greater risk of complications. Although larger pores in mesh devices were largely accepted as a safer design, the IVS mesh devices by Tyco are microporous, which could potentially promote infection, as cells cannot pass through the smaller pores.
Contact a Transvaginal Mesh Injury Lawyer Today
Product liability law dictates how much time is allowed to pass until a potential claimant no longer has the legal rights to file a lawsuit. To learn more about product liability law and how it may affect your potential case, please schedule a free consultation with a Tyco IVS mesh injury lawyer. One of our experienced defective medical device attorneys will review your case and help you determine your rights to compensation.