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On July 13, 2011, a warning was issued by The Food and Drug Administration (FDA) that addresses specifically the increasing incidence of complications resulting from mesh products and slings usage in treatingfemale incontinence, and Pelvic Organ Prolapse (POP). The latter being a condition characterized by woman’s bladder, uterus, rectum, vaginal apex and/or bowels regressing offfrom their normal positions and into the opening of her vagina. In its July, 2011 warning, the FDA summarized, among other specifications, the association between some problems and surgical mesh implantation donethrough the vagina (aka transvaginal placement). The warning also encourages people to read the report whenever they feel the need to know the details of the potential problems correlated with surgical mesh. Transvaginal Mesh’s Most Common Complication: Erosion As reflected in the July 13, 2011 FDA warning, erosion was the most commonly reported complication arisingfrom surgical mesh use in treating POP. This happens when the mesh wears out into vaginal mucosa and exposes its rough and uncomfortable surface to the patient and her partner. There were also reports of mesh contraction or shrinkage. Transvagina mesh patients also reported the following side effects: - Bleeding
- Infection
- Pain
- Urinary problems
- Blood vessel, bladder, or bowel perforation
- Vaginal tightening
- Dyspareunia (pain during sex) caused by vaginal scarring and vaginal mesh erosion
The following companies currently manufacturing mesh products include Ethicon, a division of Johnson & Johnson; C.R. Bard; Boston Scientific; and American Medical Systems. In its warning specification, the FDAstated that “the complications associated with the use of surgical mesh for POP repair have not been linked to a single brand of mesh.” Furthermore, it says, “In the Oct. 20, 2008 FDA Public Health Notification, the number of adverse events reported to the FDA for surgical mesh devices used to repair POP and SUI for the previous 3-year period (2005 – 2007) was “over 1,000.” Since then, from Jan. 01, 2008 through Dec. 31, 2010, the FDA received 2,874 additional reports of complications associated with surgical mesh devices used to repair POP and SUI, with 1,503 reports associated with POP repairs and 1,371 associated with SUI repairs. Although it is common for adverse event reporting to increase following an FDA safety communication, we are concerned that the number of adverse event reports remains high.” Learn more and get the latest facts on surgical mesh lawsuit and its side effects.
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