As of Jan. 4, 2016, surgical mesh used to repair pelvic organ prolapse (POP) transvaginally, known as transvaginal mesh or TVM, has been reclassified by the U.S. Food and Drug Administration (FDA) from a class II, moderate-risk, to a class III, high-risk device. Manufacturers of devices that are already on the market will have 30 months to submit a premarket approval (PMA) application demonstrating the safety and effectiveness of their devices. Manufacturers of new devices will be required to submit a PMA before devices are approved. This is a most significant victory for TVM victims.
First cleared by the FDA for use as a class II device in 2002, the FDA states that in the past several years there has been a significant increase in the number of reports of adverse events associated with the use of mesh for transvaginal POP repair, saying they’ve received thousands of reports of complications. Commonly reported problems include severe pelvic pain, pain during intercourse, infection, bleeding, organ perforation and urinary problems from mesh eroding into surrounding tissues.
The FDA issued safety communications warning doctors and consumers regarding these devices in both 2008 and 2011, and in 2011 an advisory panel determined that more data was needed to establish the safety of these devices. The following year, the FDA issued orders to manufacturers to begin postmarket surveillance studies, culminating in the two orders issued this week, reclassifying the devices as class III, high-risk, and requiring manufacturers to submit a PMA application.
In the press release on the U.S. Department of Health and Human Services website, William Maisel, M.D., M.P.H., deputy director of science and chief scientist for the FDA’s Center for Devices and Radiological Health said:
These stronger clinical requirements will help to address the significant risks associated with surgical mesh for repair of pelvic organ prolapse. We intend to continue monitoring how women with this device are faring months and years after surgery through continued postmarket surveillance measures.
The FDA ruling confirms what we have been seeing from injured women in this litigation – transvaginal mesh used to treat pelvic organ prolapse is responsible for serious, chronic injuries for the women in which it was implanted. The biggest tragedy in these cases is that these injuries could have been avoided if these products had been properly tested, and patients and doctors had been fully informed about the risk involved in using transvaginal mesh. The FDA should focus the same scrutiny on devices used to treat stress incontinence, classify those devices as high risk and require manufacturers to conduct clinical trials. We suspect that the results of those clinical trials will further establish that the risks of chronic pain and urinary dysfunction are unacceptably high and that polypropylene mesh is an unsuitable product to be implanted in the female pelvis.
Source: U.S. Food and Drug Administration