Outdated System Allows Approval of Dangerous Medical Devices in Texas

After 12 years, the FDA is reviewing its approval of transvaginal mesh.

Transvaginal mesh implants are used to treat pelvic organ prolapse and stress urinary incontinence in women. Before the use of transvaginal mesh, a woman who suffered from vaginal prolapse would be treated with traditional surgery. The surgery would involve a two week hospital stay and a long recovery time. It wasn't always effective.

Since 1998, millions of women have been treated with transvaginal mesh. It is generally considered a better option than surgery because it is faster and less expensive. However, about 15 percent of women experience adverse effects after receiving transvaginal mesh implants-and now the FDA says that transvaginal mesh may not be any more effective than traditional surgery. So why has this medical product been used for so long?

Transvaginal mesh was approved for the treatment of pelvic organ prolapse through a 35-year-old process known as the 510(k) system. This process is used by the FDA to review about 90 percent of medical device applications that they receive each year. The system is designed to allow low-risk medical devices to be quickly approved. However, loopholes allow higher-risk devices with ties to older products to speed through the system and circumvent testing. After numerous recalls of products approved through this system, the FDA has acknowledged that the practice may put the public at risk.

If you have been harmed by a defective medical device, you have the right to seek compensation. Contact Dallas transvaginal mesh lawsuit attorney Kay Van Wey to learn more.