Transvaginal mesh was intended to make it easier to correct physiological issues that occur as women age. It is a fibrous, net-like medical device that was introduced to be implanted through the vagina or “transvaginally” for conditions such as pelvic organ prolapse (POP) and stress urinary incontinence (SUI).
Transvaginal mesh was modeled after surgical mesh used to repair other conditions such as hernia. It was approved by the Food and Drug Administration (FDA) in the mid-1990s under the FDA’s 510(k) exclusion process for medical devices. The 510(k) process allows manufacturers to claim that their product does not require testing if it not substantially different than other products on the market. Transvaginal mesh was approved based on its similarity to mesh used for other surgical procedures but had never been tested for transvaginal repair of POP or SUI.
Vaginal mesh has been implanted in hundreds of thousands of women, causing serious adverse events such as vaginal erosion, organ perforation, need for revision surgery and death in some patients. None of these events were identified until after the device had been approved and even after the risks were shown, the devices continue to be used. Transvaginal mesh repairs not only cause serious medical issues, but they also fail to repair the original issue in up to 10 percent of all patients.
Nearly 100 thousand lawsuits have already been filed against multiple manufacturers of transvaginal mesh and more are expected.
Side Effects of Transvaginal Mesh
Transvaginal mesh may cause a number of side effects. While most of the adverse events caused by the device are not life threatening, some of them are severe and may become permanently debilitating. Serious Adverse Events (SAEs) of transvaginal mesh include:
- Pain or discomfort of the vagina or in the surrounding pelvic region
- Pain during intercourse
- Recurrence of POP or SUI
- New occurrence of SUI
- Vaginal Scaring
- Vaginal wall erosion
- Increased risk of infection
- Excessive vaginal bleeding
- Nerve damage including pain or loss of sensation in the vagina or surrounding pelvic region
- Vaginal or other organ perforation
Transvaginal Mesh Organ Perforation
Transvaginal mesh can erode or embed itself into the vaginal wall. Eventually over time, the mesh may perforate the vagina. This may cause significant pain, thickening of the vaginal wall, vaginal shrinkage, painful or impossible intercourse, vaginal bleeding, and increase the risk of severe infection. It will usually require surgery to remove the vaginal mesh and correct the damage done to the vagina. In many cases, multiple surgeries will be required and damage may be permanent. If the condition is not treated immediately, the patient may be at risk of death.
Transvaginal mesh may also perforate other organs in the abdominal cavity such as the bladder, colon, or kidneys. Perforation of essential organs may cause emergent or life-threatening medical conditions including sepsis or kidney failure. Perforation of essential organs will certainly require immediate surgical correction and damage may be permanent or result in death.
Transvaginal organ perforation is cited as the most frequently reported serious adverse event caused by the device. Between 2008 and 2010, the FDA received nearly 3,000 serious adverse event reports regarding transvaginal mesh, most of which were organ perforation events. During that period, at least 7 deaths are attributed to the device.
Based on those reports, the FDA strengthened warnings about the device stating that the mesh did not appear to be more effective than other SUI or POP methods and put the patient at a greater risk than other procedures. The FDA required that 44 manufacturers of transvaginal mesh products conduct over 100 clinical studies to evaluate the safety and risks of their products. Despite this warning and the results of clinical studies, neither the FDA, nor the manufacturers have withdrawn the devices from the market.
Transvaginal Mesh Lawsuits
Many of the problems that have occurred from transvaginal mesh implants may be attributable to the lack of clinical studies performed before the devices were put into use. None of the transvaginal mesh products had been used in women before they were introduced to the public. The first transvaginal “bladder sling” was a mesh product that was recalled just three years after its approval. Despite the clear risks, companies continued to create and manufacture additional products to eventually be used in over 75 thousand procedures each year.
To date nearly 100 thousand lawsuits have been filed against manufacturers of the devices particularly against notable companies including:
- American Medical Systems / Endo
- Ethicon / Johnson & Johnson
- Boston Scientific
- Cook Medical Inc.
- Coloplast Corp
- Cook Medical Inc.
- C.R. Bard
Lawsuits have claimed that the companies failed to conduct appropriate testing of the devices to be used for female pelvic disorders, concealed information about and misled the FDA and medical community as well as the public at large regarding the efficacy and safety of the devices, and failed to establish appropriate safe and effective methods for removal of implants.
Of the near 100 thousand lawsuits currently filed against manufacturers of the transvaginal mesh products, some have been settled including:
- A jury verdict of $5.5 million against C.R. Bard in 2012 to a Bakersfield CA couple
- A jury verdict of $3.35 million against Ethicon / Johnson & Johnson in 2013 to an Atlantic City, NJ woman
- A jury verdict of $2 million against C.R. Bard to a Charleston, WV woman in 2013
- An undisclosed number of private settlements by AMS/Endo who agreed to pay $54 million to litigants in 2013
- A Bloomberg News indicating that certain manufacturers were considering out of court settlement of up to $30 thousand per claim but an agreement has not been announced
- Settlement of 20 thousand cases for $830 million by AMS/Endo
- Settlements of 400 lawsuits for up to $16 million by Coloplast
Many lawsuits have been consolidated into multidistrict litigation (MDL) in the U.S. District Court for the District of West Virgina and include over 40 transvaginal mesh products. The cases will be supervised by Chief Judge Joseph R. Goodwin and include at least six different MDL consolidations.
Plaintiffs can be awarded for both actual damages (medical costs, disability) and punitive damages (to punish the company). Thousands of transvaginal mesh lawsuits have not been settled and many more are expected.