Transvaginal mesh used to treat Pelvic Organ Prolapse (POP) or Stress Urinary Incontinence (SUI) can cause serious complications and adverse events for patients. First approved for use by the FDA in 1996, the serious complications and injuries caused by transvaginal mesh erosion prompted the FDA to issue strong warnings advising against its usage in 2008.
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Following numerous reports of injuries, the FDA changed the classification of transvaginal mesh from “moderate risk” to “high risk” in 2016. It is estimated that up to 1 in 10 women will experience serious complications following transvaginal mesh surgery.
Transvaginal Mesh Erosion & Complications
Transvaginal mesh is composed of polypropylene plastic. As the plastic ages, it can break down and erode. As it does this, the pieces of polypropylene become entwined within soft tissue. This can cause considerable pain and discomfort to patients.
In addition to pain and discomfort, transvaginal mesh erosion can cause pieces of the device to break free and perforate organs. This can cause considerable internal bleeding and life-threatening infections. For example, if a piece of the mesh perforates a blood vessel, it can create a portal which would allow urine or fecal matter to enter the bloodstream. In turn, this can cause a deadly septic infection.
Other injuries associated with transvaginal mesh erosion include nerve damage, fistulas, uncontrolled vaginal bleeding, bruising, painful intercourse, and permanent scarring. These can have a significant effect on a woman’s quality of life.
Women who experience negative side-effects may or may not find resolution with the removal of the device. However, the devices are not designed for easy removal and it may require multiple surgeries to successfully extract the device and any pieces that have broken off. These surgeries can have a significant impact on a woman’s quality of life, employment, etc.
Assigning Liability for Injuries
There are a number of people who may be accountable for the injuries caused by transvaginal mesh. These include the physician who prescribed the treatment, the surgeon or surgical team conducting the surgery, and the manufacturer.
Assigning liability requires a personal injury lawyer to first determine the cause of the failure. Transvaginal mesh failure can be caused by poor design or poor placement. Moreover, liability may be assigned if a physician or surgeon failed to adequately inform the patient of the known risks and well-documented dangers associated with the device.