Monthly Archives: February 2012

House Democrats Call For Vaginal Mesh Safety Hearings

Congressional Democrats are urging their colleagues to investigate the safety of vaginal mesh medical devices after months of news reports and vaginal mesh lawsuits have circulated and called attention to the growing safety problem with the meshes.
Transvaginal or vaginal mesh devices were originally approved for use to treat urinary incontinence in women as well as female pelvic organ prolapse. However, the meshes have proven to be ineffective in treating either condition and they have serious safety problems as well.
According to one media report, “House Democrats called on congress to not only hold hearings on Lap-Band and transvaginal mesh, but also on brain stents and metal-on-metal hip implants, which they had previously requested on October 12, 2011. They also called on the Committee to request documents from various facilities regarding their marketing of Lap-band and to seek safety and procedural documents from vaginal mesh manufacturers.
The Lap-Band is a device that is surgically implanted and wrapped around the upper portion of a patient’s stomach to reduce the size of the stomach. However according to the House Democrats’ correspondence, the device can pose serious risks including erosion of the band through the stomach wall, stretching the stomach pouch, stomach pain, gastroesophageal reflux disease, difficulty swallowing, nausea, and vomiting.
Transvaginal mesh implants are permanently implanted in the vaginal wall to treat pelvic organ prolapse and urinary incontinence. These mesh devices were permitted on the market under the 510(k) clearance process, which fast-tracks medical devices onto the market without clinical testing. However, according to an FDA Safety Communication dated July 2011, these devices pose serious side effects such as vaginal mesh erosion (also called exposure, extrusion or protrusion), pain, painful sexual intercourse (also called dyspareunia), infection, urinary problems, bleeding, organ perforation, recurrent prolapse, neuro-muscular problems, vaginal scarring/shrinkage and emotional problems.”