Any fans of overnight television have probably seen the commercials by now. It has even appeared on Facebook. A search on the social site reveals six homepages dedicated to class action lawsuits that involve the placement of transvaginal mesh. Some attorneys have stooped so low that they are now contacting patients several days after their procedures have been done, as well as patients who had these procedures done many years ago and have had successful outcomes, without any complications, despite the use of mesh. The goal of this blog will be to shed some light on this controversial topic.
Surgical mesh has been utilized for many years for various conditions. Dating back to the 1950's, these implants are most commonly used to repair hernias. In the 1990’s a variety of mesh products became available for Urologists to use for the treatment of both stress urinary incontinence (leakage which occurs with coughing, straining or and increase in the intra-abdominal pressure.) The procedures for the treatment of stress incontinence involve several small incisions made in the vagina in the region of the urethra and possibly in the folds of the groin. Through these incisions, a piece of mesh is passed such that a portion of the urethra will come to rest on the mesh, effectively closing the urethra when the intra-abdominal pressure increase. This will effectively treat the stress incontinence in nearly 98% of women. Despite claims that are being made by unscrupulous attorneys, the use of mesh for the treatment of stress incontinence is NOT subject to scrutiny by the FDA and should not be the basis of these legal efforts.
In addition to the use of the mesh for the above indications, surgical mesh has been used for the treatment of pelvic organ prolapse since the 1990s and received FDA clearance for these procedures in 2002. Pelvic organ prolapse occurs when the support of the pelvic organs stretches or becomes weak, resulting in the pelvic organs either protruding into the vaginal cavity or in severe cases beyond the opening of the vagina. This will commonly result in a bulge or lump in the vagina, a sensation of something falling out of the vagina, painful intercourse, loss of bladder control especially when coughing or sneezing. Other results include difficulty with bowel movements, waking up more than 2 times per night to use the bathroom, the sensation that the bladder still feels full even though you just went to the bathroom, a delayed or slowed urine stream and even lower back pain.
Conventional surgical repairs of pelvic organ prolapse are associated with high failure rates and as a result, surgeons began turning towards synthetic materials to decrease the recurrence rates. On October 20, 2008, the FDA issued a statement that these rare complications associated with transvaginal placement of surgical mesh to treat Pelvic Organ Prolapse exist that can have consequences. This resulted from a series of reports that identified complications such as erosion of the mesh through the vaginal wall, infection, pain, urinary problems and recurrence of the prolapse or the incontinence. Several more serious complications were also identified including injuries to bowel, bladder and blood vessels. At that time some of the recommendations made to physicians was to obtain specialized training for mesh placement, to inform the patients of these potential complications with mesh and to weary of the potential complications.
On July 13, 2011, the FDA issued an update on this topic which changed the wording regarding these complications from “rare” to “not rare." Additionally the FDA questions whether the efficacy of these mesh procedures are more efficacious than traditional non-mesh repairs. As a result, the FDA continues to evaluate the effects of using surgical mesh. The most common complications reported to the FDA were erosion of the mesh through the vagina, pain, infection, bleeding, and pain during intercourse. As a result of this latter report, additional recommendations were made by the FDA that included choosing mesh surgery only after weighing the risks and benefits of surgery with mesh against all surgical and non-surgical alternatives.
Despite the FDA warnings many people continue to offer mesh surgery as an excellent option for a variety of reasons. There are many surgeons who have performed numerous mesh cases and have had outstanding results. Some believe that in the hands of experienced surgeons, the risks of these procedures are not those reported by the FDA. The use of preoperative estrogen creams for a period of time long enough to maximize the thickness of the vaginal wall may be helpful in reducing complication rates. Numerous randomized controlled studies demonstrate success rates with mesh that exceed traditional repairs by nearly 30%. Additionally, the vast majority of complications are not major and in many cases can be easily treated. Lastly, not all patients are candidates for the placement of mesh. A careful preoperative assessment will identify the best patients for these procedures, and eliminate those who are not.
So if you are suffering from Pelvic Organ Prolapse, don’t listen to the ambulance chasing attorneys who are plastering the airwaves and social media outlets seeking clients for these class action lawsuits. See a Urologist or Uro-gynecologist who specializes in these repairs. Your evaluation at that time will result in what will most likely be a success whether mesh is used or not, and the potential for complications will be greatly minimized.
Published On: October 11, 2014