Leeza Gibbons and Bill Rancic of America Now report on a woman from Curtice in the United States who experienced pain and complications from mesh implant surgery. Teresa Sawyer developed devastating complications after her TVT surgery to cure stress incontinence. Although she was told that this would be “routine surgery”, Teresa suffered debilitating problems from this surgery and lives a life filled with pain.
America Now’s article explains how the US Food and Drug Administration (FDA) has received more than 2,800 reports of cases like Teresa’s where patients have developed complications following mesh implant surgery.
Surgeon Tom Margolis maintains that the surgery violates “core basic surgical tenets” because it requires inserting the device through the vagina, which is not a sterile surgical environment. He remarks that erosion rates have been shown to be unacceptably high – as much as 15.6 percent. Margolis argues that industry has hired key doctors to promote this product and the complications may have been under-reported.
The news feature comments on how the mesh device was cleared under the FDA’s 510k regulatory pathway for medical devices which meant it did not undergo testing before being approved because it was deemed similar to a product which was already on the market. Recent hearings at the FDA have resulted in a call for more extensive testing. The mesh device remains on the market at present.
Click on link to view the video footage on America Now: America Now New’s Story: Routine Surgery Dangerous for Women
Read Teresa’s story in “The Press”: http://www.presspublications.com/health/9045-curtice-woman-warns-others-not-to-get-surgical-mesh-implants
Click on link to visit Teresa and David Sawyer’s website: http://www.tvtno.org/index.html