Food and Drug Administration (FDA) Mesh Warnings
Transvaginal mesh implants have been used for several years to treat pelvic organ prolapse (POP), stress urinary incontinence (SUI), and other conditions in the lower abdomen. The mesh comes in the form of a patch or sling that is usually implanted between the bladder and the uterus. Its function is to keep the pelvic organs in their proper places. When it works correctly, the device alleviates abdominal pain, allows for normal bladder control, and treats other medical conditions.
Unfortunately, the devices don’t always work correctly. Thousands of patients in recent years have suffered complications from transvaginal mesh implants, some of them severe. In some patients, the damage caused by the device has actually been worse than the damage the device was intended to treat.
Transvaginal Mesh Complications Revealed
In 2008, the U.S. Food and Drug Administration (FDA) issued its first official warning to healthcare providers about the potential risks of using transvaginal mesh products. The 2008 warning covered the following points:
- From 2005 to 2007, the FDA received over 1,000 complaints of complications from patients suffering side effects after a transvaginal mesh implant.
- The most frequent problems reported were erosion of the mesh through the soft tissues in the abdomen, pain, internal bleeding, urinary incontinence, and infections in multiple abdominal systems, including urinary tract infections and infections in the soft tissues lining the abdominal cavity.
- Treatments for the complications included IV antibiotics, blood transfusions, draining hematomas or abscesses, and surgery to correct the problems caused by the mesh and/or to remove the mesh.
- No specific risk factors for complications had been identified, so doctors should consider each patient’s case individually.
The FDA recommended that physicians receive specialized training on the use and placement of transvaginal mesh implants and that they watch closely for signs of complications in their patients. Healthcare workers were also advised to give patients detailed information on the possible risks of transvaginal mesh use, including a copy of the product’s warning labels.
More than Just a “Rare” Problem
In 2011, the FDA issued an updated warning about the use of transvaginal mesh implants. The warning began by emphasizing that, contrary to the 2008 warning, transvaginal mesh complications were “not rare.” The FDA also noted that the scientific evidence supporting transvaginal mesh use was weak, and it was likely that surgery to correct pelvic organ prolapse without transvaginal mesh was just as effective as surgery that used transvaginal mesh – but without the increased risk of complications the mesh posed.
The update also noted that, between 2008 and 2010, the FDA received an additional 2,874 complaints about transvaginal mesh complications. In addition to the problems the FDA identified in the 2008 warning, the 2011 warning listed dyspareunia (pain during intercourse), internal organ damage, permanent scarring, and trauma-related mental health symptoms as serious concerns.
The 2011 warning repeated the recommendations given in the 2008 warning and added a few new ones. Specifically, the 2011 warning recommended that doctors use transvaginal mesh implants only when the benefit in a particular patient outweighed the risks and only after all non-mesh-using treatment options had been exhausted. The new recommendations also called for greater patient education about the possible risks of transvaginal mesh use, and they offered patients a list of questions to ask their doctors before undergoing surgery.
Jacksonville Mesh FDA Warning Lawyers Prepared to Protect Your Rights
The pain, organ damage, and other complications a transvaginal mesh implant can cause are devastating and often permanent. If you’ve suffered side effects from transvaginal mesh use, contact the Jacksonville product injury attorneys at Farah & Farah at 855-797-9899 for a confidential consultation. We are devoted to winning successful case results for our clients.