The Food and Drug Administration (the FDA) on July 13, 2011, issued a warning specifically addressing the high incidence of complications occurring as a result of using mesh products and slings to treat women’s incontinence, and Pelvic Organ Prolapse (POP)—a condition in which a woman’s bladder, uterus, rectum, vaginal apex and/or bowels slip down from their normal positions into her vaginal opening.
In its July, 2011, warning, the FDA—among other things—summarized the problems that have been associated with implanting a surgical mesh through the vagina (transvaginal placement), and encouraged people who want to know the details of the potential problems associated with surgical mesh to read this report.
Erosion is the Most Common Complication
According to the FDA’s July 13, 2011, warning, the most consistently reported complication that arose when using surgical mesh to treat POP was erosion: the mesh wore through the vaginal mucosa and exposed its rough and uncomfortable surface to the patient and her partner. Patients also reported instances of mesh contraction (shrinkage).
Other side effects that vaginal mesh patients reported included:
- Urinary problems
- Blood vessel, bladder, or bowel perforation
- Vaginal tightening
- Dyspareunia (pain during sex) caused by vaginal scarring and vaginal mesh erosion
Recent Warnings Do Not Single Out Any Brand
Several companies currently manufacture mesh products, including: Ethicon, a division of Johnson & Johnson; C.R. Bard; Boston Scientific; and American Medical Systems. The FDA’s July 13, 2011, warning specified that “the complications associated with the use of surgical mesh for POP repair have not been linked to a single brand of mesh.”
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