A growing number of women have reported serious complications including surgery mesh erosion following surgical repair of POP and SUI. Transvaginal mesh devices are made by several manufacturers, and designed to treat pelvic organ prolapse (POP). This is a condition in which several organs, such as the uterus, bowels, and bladder, fall into the vaginal opening. The anatomical supports (pelvic muscles, ligaments, etc.) that normally prevent this from happening fail. Surgical mesh has been used for decades to resolve this problem. However, when doctors began to install the device through the vagina rather than the abdomen, a number of serious transvaginal mesh failure side effects were reported. Women experienced mesh erosion, vaginal infections, bleeding, and many other complications.
The Food and Drug Administration has been aware of the problems caused by transvaginal placement of mesh for treating POP for years. They released a safety warning about the device in 2008, mentioning the agency had received over 1,000 reports of complications during the preceding three years. Today, the FDA is considering reclassifying surgical mesh to require that it undergo a more rigorous approval process. This has not stopped hundreds of women from filing vaginal mesh lawsuit claims, seeking compensation for their injuries.
FDA’s Position On Surgery Mesh Complications Changes
When the FDA released their initial safety warning on October 20, 2008, their position was cautionary, but reserved. They claimed that the complications stemming from transvaginal mesh placement for pelvic organ prolapse posed serious consequences, but were “rare.” The agency recommended that doctors seek special training for mesh placement and be watchful of potential side effects.
On July 13, 2011, the FDA’s original safety warning was updated with new language regarding the risks involved with vaginal placement of surgical mesh. It now stated that serious side effects stemming from the procedure were “not rare.” The update also notes that the number of adverse events reported to the agency following the original warning tripled.
There is also very little evidence that placing pelvic mesh transvaginally is safer or more effective than repairing pelvic organ prolapse via traditional methods. A review of scientific literature published between 1996 and 2011 revealed little proof that vaginal placement improved the patient’s “quality of life over traditional non-mesh repair.” The FDA repeated their recommendations to doctors, and encouraged them to seek other methods for repairing POP.
Possible Change To Transvaginal Mesh Classification
Due to the numerous complications that women have reported after undergoing vaginal mesh placement, the FDA is considering a broad reclassification for the device. In the past, the product was able to gain FDA approval through the agency’s controversial 510(k) premarket notification process. This process allows manufacturers to bring medical devices to market with very little testing. The requirement is that they must be able to prove their products are “substantially equivalent” to others that are already being legally marketed.
A lack of clinical trials increases the likelihood that a given medical device will cause complications. The FDA’s 510(k) approval process is thus widely-regarded as needing reform. Despite this, the agency notes in a September 2011 report regarding obstetrics and gynecology devices that they are not proposing a formal reclassification of pelvic mesh products. They are merely considering it as a way to improve the devices’ safety and effectiveness. Reclassifying these products as Class III medical devices would preclude them from the 510(k) approval process.
Side Effects Lead To Transvaginal Mesh Lawsuits
According to a September 8, 2011 article in BusinessWeek, Johnson & Johnson and C.R. Bard currently face nearly 500 pelvic mesh lawsuits. A few lawsuits are also being pursued against other manufacturers. Given that 75,000 women opt to have the device implanted transvaginally each year, this number is expected to grow.
Some lawsuits argue that the manufacturers of surgical mesh should have tested their devices more thoroughly before introducing them to an unsuspecting public. Other plaintiffs claim they were not properly informed by the manufacturers regarding the potential side effects caused by the devices.
While some surgery mesh complications can be resolved through surgery, many are virtually untreatable due to erosion of the device through the vaginal wall. Many women have been forced to endure vaginal infections, bleeding, pain during sexual intercourse, and other issues.
If you received a pelvic mesh implant and have suffered surgery mesh erosion or other side effects, you may be eligible for compensation for your injuries. Contact a transvaginal mesh lawsuit lawyer to discuss your options.
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