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FDA Warns Device Erosion as Potential Risk from Bladder Mesh Devices

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					     FDA Warns Device Erosion as Potential Risk from Bladder Mesh Devices




                                             Within a duration of three years (2005-2007), over 1,000
                                             reports of adverse events tied to vaginal mesh implants
                                             have been accounted for by the United States Food and
                                             Drug Administration, according to online news reports. In
                                             connection with this, the agency dispensed a warning in
                                             2008, a Public Health Notification that highlighted the
                                             potential risks from pelvic or surgical mesh devices for
                                             pelvic organ prolapse (POP), and stress urinary
                                             incontinence (SUI) treatment. The safety alert, which was
sent out to inform both the medical community and the public, warns of the possible medical
consequences that may result from these potential risks, and provides recommendations on how to
minimize them. The number of adverse-event reports received by the agency never showed signs of
decrease since then, increasing up to 2,874 from 2008 through 2010, and leading to legal claims filed
against surgical mesh device makers.



Bladder mesh implants are medical devices used in surgical procedures that aim to provide support to
organs affected by POP (prolapse of organs in the pelvis), and SUI (bladder leakage problem) in most
women, health experts say. Although they may be implanted through an incision to the abdomen, most
surgeons prefer a less invasive technique of placing them through the vagina. The use of bladder mesh
for POP repair, however, when inserted through the vagina, has been linked to a series of inadvertent
effects in an increasing number of patients.



In an updated Safety Communication released by the US FDA in 2011, the agency highlighted a string of
adverse events that occur as a result of the transvaginal placement of mesh devices for POP repair,
according to online news reports. One of the most prominent of reported complications is mesh erosion
– an adverse effect that has been seen to cause women to bleed, swell up, develop infections,
experiencing chronic pain, as well as emotional challenges, and suffer from internal injuries and
aggravated urinary problems. The pain and discomfort brought about by the erosion or protrusion of the
device to nearby organs, as well as vaginal scarring, have been reported to significantly diminish the
quality of life in patients. An early study also suggested that although it may take a while for mesh
problems to start taking place, an estimated 10 percent of 12,000 study cohorts have been observed to
experience the complication a year following implantation.
Some of these complications may need further corrective surgeries or hospitalization to correct,
according to medical experts. In light of this, the FDA encourages women to possibly prevent
unnecessary added health problems by weighting the benefits against the potential risks related to
mesh devices for POP and SUI repair with their performing surgeons. Comprehensive information
related to the possible unanticipated effects of pelvic mesh repair devices may be found in
bladdermeshlawsuit.us.

				
DOCUMENT INFO
Description: Within a duration of three years (2005-2007), over 1,000 reports of adverse events tied to vaginal mesh implants have been accounted for by the United States Food and Drug Administration, according to online news reports. In connection with this, the agency dispensed a warning in 2008, a Public Health Notification that highlighted the potential risks from pelvic or surgical mesh devices for pelvic organ prolapse (POP), and stress urinary incontinence (SUI) treatment. bladdermeshlawsuit.us