The FDA recently released an update on the surgical mesh implant devices based on an assessment of Medical Device Reports that were given to the FDA. The FDA is considering the recommendation that the urogynecologic surgical mesh used in the transvaginal repair of pelvic organ prolapse (POP) to be classified as a Class III, instead of a Class II medical device.
The surgical mesh is a medical device used to repair weakened or damaged tissue in females. It’s typically used in repairing of POP and stress urinary incontinence (SUI). Doctors use the surgical mesh implant device to reinforce the weakened vaginal wall for POP repairs or to repair SUI, to support the urethra or bladder neck.
According to the FDA, they continue to assess the safety and effectiveness of the surgical mesh devices through published literature; Medical Device Reports; epidemiological research on safety and effectiveness of surgical mesh; speaking with professional societies and other stakeholders; and collecting and reviewing available information about the currently marketed surgical mesh devices and requiring companies to complete surveillance studies.
On January 3rd the FDA specifically called for: “88 postmarket study orders to 33 manufacturers of urogynecologic surgical mesh for POP; and 11 postmarket study orders to seven manufacturers of single-incision mini-slings for SUI.”
This means that manufacturers of this surgical mesh implant device are now required to submit study plans to the FDA to address specific safety and effectiveness concerns for the medical device.
According to the FDA, significant complications resulting from transvaginal mesh patches are not rare and commonly include serious issues such as:
- Erosion of the vaginal tissue
- Urinary problems such as incontinence
- Pain during sexual intercourse (dyspareunia)
- Organ perforation (puncturing) from surgical tools during mesh implantation
Less frequent problems included
- Return of POP
- Neuro-muscular problems
- Vaginal scarring/shrinkage
- Emotional problems
If you have suffered complications due to the implantation of a transvaginal patch to treat POP, Contact Us the experienced medical device lawyers of Childers, Schlueter & Smith, LLC for a free consultation today by calling us toll-free at (800) 641-0098.