FDA Issues Safety Warnings over Health Risks Tied to Surgical Mesh Surgery using surgical mesh implants have been reportedly common in treating pelvic problems among women such as pelvic organ prolapse (POP) and stress urinary incontinence (SUI), health experts say. Since their introduction to the American consumer market, however, surgical mesh implants purported to cause a string of unwanted effects, prompting the United States Food and Drug Administration to raise the alarm over their safety.
The agency initially issued a public health notification in 2008, warning medical practitioners of the risks that may potentially stem from pelvic mesh devices, online media reports. In response to more than 1,000 adverse-event reports associated with attempts to remedy POP and SUI by inserting surgical mesh through the vagina, the agency highlighted that these complications may have serious, albeit rare, medical consequences.
Since the 2008 Public Health Notification, between 2008 and 2010, complaints related to the risks associated with these devices have reportedly prevailed to increase, with 2,874 additional reports of complications, as has been cited by the US FDA. Subsequently, the agency issued a safety communication on July 13, 2011, announcing that â€œserious complications associated with surgical mesh for transvaginal repair of POP are not rare.â€? It was also further revealed in the safety communication that using surgical mesh for POP repair may be less beneficial for patients in terms of improvement of symptoms and quality life compared to conventional surgical treatment, according to results from a study conducted by the FDA.
Complications that were reportedly to commonly occur as a result of using surgical mesh for the treatment of POP include mesh erosion through the vagina, excruciating pelvic or vaginal pain, infection, urinary problems, and dyspareunia (painful sexual intercourse). The agency advises women considering surgery to learn more about the risks associated with bladder mesh implants and consult their doctors for other possible options. Check this site for added information about the potential health risks linked to surgical mesh devices.