Transvaginal mesh is a plastic, net-like surgical implant intended to treat conditions that can occur after a hysterectomy, menopause or childbirth, including stress urinary incontinence (SUI) and pelvic organ prolapse (POP). Unfortunately, complications arising from vaginal mesh implants have prompted women across the U.S. to file over 50,000 transvaginal mesh class action lawsuits.
According to a recent study published in the medical journal JAMA Surgery, transvaginal mesh slings are allegedly safe. This study is not without its critics, most notably because the same study revealed one out of every 30 women who received a transvaginal mesh implant will need another surgery to repair or remove the implanted mesh within ten years of their initial surgery. Dr. Blayne Welk, a professor at Ontario, Canada's Western University Schulich School of Medicine and Dentistry, conducted the study published in JAMA Surgery.
Welk and his colleagues observed nearly 60,000 transvaginal mesh recipients for a period of ten years to determine which of the recipients may require a second surgery to resolve complications stemming from the implanted mesh.
Welk noted many of the women involved in the study suffered from a wide range of complications, including infections, pain, urinary problems, and mesh disintegration; all indications that a second corrective surgery may be warranted.
However, Welk determined the experience level of the surgeon who performed the mesh implant operation played the greatest role in a patients overall success rate, more so than the integrity of the mesh itself. According to the study, patients fared significantly better when their surgery was performed by a more experienced surgeon.
Regardless of a surgeons experience level, the Food and Drug Administration (FDA) seems to think the wide array of complications associated with the mesh product is worth investigating, even though the administration had given its seal of approval to the mesh years ago.
In a 2001 report released by the FDA, complications resulting from mesh implants were deemed not rare. In 2014, the FDA released a statement describing the risks involved with mesh slings used to treat POP, a condition which causes certain internal organs to bulge, or prolapse into the vagina. Additionally, the FDA announced it had plans to reclassify transvaginal mesh as a "high-risk" device in April, 2014, leaving many to speculate as to the validity of Welk's recent study.
However, despite the call-to-action by the FDA in April, 2014, the administration has yet to reclassify transvaginal mesh as a high-risk medical product, something most healthcare advocates and women injured by the mesh feel is mandatory and ethically responsible.
If you or a loved one has suffered from injuries or complications arising from a transvaginal mesh implant, call the experienced defective medical device lawyers at the Arnold Law Firm today.