Transvaginal Mesh Study Suggests FDA Took Too Long to Act
Posted on Friday, March 6th, 2020
Women treated with transvaginal mesh are 40% more likely to need surgery later.
Friday, March 6, 2020 – A study of over 54,000 women who were treated with transvaginal mesh for pelvic organ prolapse (POP) revealed that nearly 1 in 5 endure complications that will likely affect them for the rest of their lives. Just as significantly, the study’s authors say that their findings reinforce the case that the FDA should have intervened sooner in taking the dangerous medical devices off of the market.
The study, a follow-up to an earlier long-term study published in 2015, was conducted by physicians from Weill Cornell Medical College-New York Presbyterian, Warren Alpert Medical School of Brown University, University of Oxford, and Women & Infants Hospital. It was published in the March 2020 issue of the peer-reviewed journal, Obstetrics & Gynecology.
Surgical mesh has been used to repair hernias since the 1950s. Two decades later, without further FDA approval, surgeons expanded its use to begin repairing pelvic organ prolapse. surgeons began using surgical mesh to repair abdominal hernias beginning in the 1950s. In the 1970s, gynecologists began implanting surgical mesh as an off-label use for abdominal repair of POP.
In 2002, the FDA cleared the first transvaginal mesh for use in treating POP, classifying it as Class II “moderate risk” for complications.
All along, patients experienced issues with mesh. Because of the nature of mesh, tissue grows around and through it, making it extremely difficult to remove, and complications challenging to repair. In some patients, it migrated and adhered itself to organs and other internal tissues. In others, it perforated bowels and other abdominal organs.
By 2008, the FDA announced that it had received more than 1,000 reports of adverse events related to use of transvaginal mesh. They reclassified transvaginal mesh as a Class III device, or “high risk” for complications, forcing manufacturers to obtain premarket approval before transvaginal mesh could be sold. Reports of problems continued to come in.
Four years later, in 2012, the FDA requested post-market studies from the 34 manufacturers producing transvaginal mesh products. The agency later reported that surgeons failed to participate in the studies. However, the move prompted many of the manufacturers to recognize that transvaginal mesh was creating a liability, so rather than comply with the study request, they discontinued manufacturing the mesh.
Meanwhile, by 2017, surgeons and physicians in other countries took action. The UK National Institute for Health and Care Excellence announced that transvaginal mesh should only be used in research. Australia and New Zealand banned use of transvaginal mesh altogether.
It wasn’t until April 2019 that the FDA ordered a halt to the sale of transvaginal mesh, saying the manufacturers failed to provide reasonable assurance that it was safe for long-term use. By that time, thousands of women had filed lawsuits against manufacturers after they experienced often-devastating complications, including pain, bleeding, and puncture of vaginal tissue and bowels.
This latest study has helped to establish just how many women experience these types of complications. The physicians studied 54,194 women treated for POP — 12,989 with mesh, and 41,205 without mesh — and found that about 8.8% of those treated with mesh needed reintervention surgery within 5 years. That number is 40% higher than for those who are not implanted with transvaginal mesh.
The study concluded, “Almost one in five of the surgical reinterventions were coded as resulting from mesh-related complications. Further, there was no decline in mesh erosion rates over the study period, implying this is an ongoing risk.
“… The United States was late in the removal of mesh implants for POP despite the numerous safety warnings and adverse events reported from patients’ narratives.”
If you were implanted with transvaginal mesh in 2001 or later and suffered complications that required removal of the mesh, contact OnderLaw for a free, no-obligation consultation at (314) 963-9000.