About Mesh Implants
Alarming Statistics
- Between 2005 and 2010, the FDA has received approximately 4000 reports of adverse events associated with surgical mesh devices used to repair POP and SUI.
- Since 2008, the FDA has received roughly 2,900 complaints about transvaginal mesh complications, of which more than 1,500 involved use of the mesh in POP repair.
- In 2010 alone, approximately 100,000 mesh implants were implanted in women living in the United States. More than 75,000 women had mesh implanted transvagainally to repair pelvic organ prolapse.
- Approximately 10% of women who receive TVM implants experience mesh erosion within 12 months of surgery.
- More than half of the reported complications required additional surgery to correct these complications, and even then, many women did not experience complete relief of their symptoms.
- At least three deaths have been associated with POP repair and were related to the mesh placement procedure (two bowel perforations, one hemorrhage).
Timeline of the FDA Investigation Into Transvaginal Mesh Implants
On October 28, 2008, the U.S. Food & Drug Administration (FDA) published a public health notification after receiving over 1,000 reports from nine surgical mesh manufacturers of complications that were associated with surgical mesh devices used to repair pelvic organ prolapse (POP) and stress urinary incontinence (SUI) for the previous 3-year period (2005–2007).
On July 13, 2011, the FDA released an updated report on the Safety and Effectiveness of Transvaginal Placement for Pelvic Organ Prolapse The report states that between January 1, 2008 and December 31, 2010, the FDA received a total of 2,874 reported injuries relating to the mesh used in transvaginal mesh procedures. The FDA indicated that 1,503 reports were associated with POP repairs while 1,371 reports were associated with SUI repairs.
On September 8-9, 2011, the FDA Advisory Panel released a staff report that noted that it is not clear that transvaginal POP repair with mesh is more effective than traditional non-mesh repair in all patients with POP, and it may expose patients to greater risk. The FDA Advisory Panel also proposed reclassifying transvaginal mesh as a high risk device.
The panel recommended that patients and doctors consider alternatives before turning to transvaginal mesh procedures. The September 2011 FDA report states that “based on evaluation of adverse event reports and assessment of the scientific literature, the FDA has NOT seen conclusive evidence that using transvaginally placed mesh in POP repair improves clinical outcomes any more than traditional POP repair that does not use mesh, and it may expose patients to greater risk.”
The FDA advisory panel voiced support for an agency proposal to reclassify transvaginal mesh devices as high risk, or Class III. Reclassification would drastically change how manufacturers can introduce TVM implants onto the market. Currently, transvaginal mesh devices are marketed as moderate risk, or Class II medical devices, meaning that manufactures can place TVM implants for sale without subjecting the mesh implants to any human testing. If the FDA does reclassify TVM as Class III, manufacturers would be required to conduct premarket clinical trials of transvaginal mesh devices before they could be marketed for POP surgery.
The FDA noted that the vast majority of adverse events have been among products made by Boston Scientific, Johnson & Johnson, American Medical Systems (AMS), Cook, Covidien and C.R. Bard (Bard).
Other Notable Warnings of Transvaginal Mesh Use
A 2011 study released by the Journal of Obstetrics and Gynecology Canada (JOGC) on TVM procedures stated, “Until adequate effectiveness and safety evidence is available, the use of new TVM devices for prolapse repair should be considered experimental and restricted to use in investigative trials.” Read the full JOGC report.
In an article published in an August 2010 issue of the journal Obstetrics & Gynecology, researchers reported that scientists had to stop a transvaginal mesh clinical trial early because women implanted with the mesh experienced too many complications. In the trial, which began in 2007, 65 women with prolapse underwent either surgery using the vaginal mesh or a procedure known as colpopexy that uses ligaments to help support the muscles. The trial was cut short in 2009 after researchers found that over 15 percent of the women implanted with the mesh suffered within a period of only three months from vaginal mesh erosion, a potentially serious complication involving the protrusion of the mesh when the skin splits.
