The US Food and Drug Administration (FDA) orders manufacturers of surgical mesh devices to conduct an in depth study of its safety and possible complications. The FDA sent letters to 35 manufacturers of surgical mesh devices to conduct three-year studies on hundreds of women who had surgical mesh implant to look into the adverse effects as well as the overall quality of life. The growing number of complaints to the agency called adverse event reports demonstrates that the use of the product to treat pelvic problems and to treat those with severe overactive bladder may be risky.
The FDA received more than 1,500 reports of complications related to the repairs using surgical mesh from 2008 to 2010, including instances of mesh erosion, vaginal bleeding and infection. The rate of reported adverse events was five times more than 2005 to 2007. The FDA was also concerned about scientific studies that show a lack of benefit from surgical mesh treatment, compared to non-mesh treatment. In line with this the agency is requesting for more studies from companies that manufactures the mesh for pelvic organ prolapse, (POP) surgery. In the case of transvaginal mesh used to treat stress urinary incontinence, (SUI), the FDA is seeking further study of the use of a so-called “mini-sling,”.
Previously, companies that wanted to make the mesh for POP or SUI could submit their application under a 510(k) accelerated review application that did not require them to do clinical trials in people, as long as they could show the products were similar to devices already out in the market. However, the FDA is now reclassifying the mesh as a high risk device. The manufacturers are now required to prove the product’s safety and effectiveness before it could launch. Companies applying for approval for class III devices may be required by the FDA to perform randomized controlled trials, scientific studies and post approval studies to demonstrate safety and efficacy in order to qualify for market approval. This is a more stringent process of approval required by the FDA to all surgical mesh devices.
At present the FDA continues to re-evaluate surgical mesh products. The agency encourages further studies to be conducted. It seeks to establish the causal connection of the reported adverse events to the use of the device. The studies might resolve the issues on surgical mesh complications and spare thousands of women from the hassle of having to file transvaginal mesh lawsuit.