The prevalence of pelvic floor disorder, a common gynecological problem, is high among women. Approximately 40% of women have one pelvic floor disorder. Around 17% of females suffer from two, and 6% have three disorders. The most frequently occurring pelvic floor disorder is urinary incontinence, followed by pelvic pain and fecal incontinence.
Transvaginal mesh implants help manage pelvic floor disorders by providing support to damaged or weakened tissues. However, there is tremendous controversy regarding the implantation of transvaginal mesh.
Women all across the U.S. and other countries are coming forward to share their negative experiences with transvaginal mesh implants. Some claim to have suffered chronic pain, whereas others complain of painful intercourse and trouble walking. This has triggered class actions in the U.S., Australia, and the U.K.
This gives rise to the question: is the controversy surrounding transvaginal mesh implants true, or is it baseless? We’ll uncover that in this guide.
What is Transvaginal Mesh?
Transvaginal mesh is a medical device used to treat stress incontinence among female patients. Stress continence is a condition that leads to bladder leakage during physical exertion or activity.
This net-like implant, made from polypropylene, provides extra support to repair damaged or weakened internal tissue. The mesh consists of holes so that the body can grow its own tissues into it.
Transvaginal mesh is known so because it’s inserted into the vagina. A small incision is made in the abdominal or vaginal wall, after which it is implanted and held in place by a tissue fixation device or sutures.
Often referred to as urogynaecological meshes, transvaginal meshes are also offered as a treatment option for women with pelvic organ prolapse. Half of women who’ve given birth suffer from this condition. A pelvic organ prolapse occurs when a pelvic organ such as the uterus, rectum, or bladder sags and budges out of place.
What is the Current Controversy Surrounding Vaginal Mesh?
Mass short-term clinical trials observed that complication rates are low and efficacy rates are high for mesh implants. But, a growing pool of evidence suggests low efficacy and high complication rates for transvaginal mesh implants.
In 2019, the U.S. Food and Drug Administration (FDA) banned the sale of transvaginal mesh for pelvic organ prolapse repair due to growing safety issues. Several medical societies and manufacturers of urogynecological mesh declare it’s safe for use, but research says otherwise.
In a qualitative study of 74 women with urogynecological conditions, fifteen of them reported being injured by the vaginal mesh. Roughly one in every ten women who had vaginal mesh inserted for stress urinary incontinence developed a complication perioperatively within 30 days or up to five years after the procedure. This was concluded by population data from Scotland.
Women who got the mesh implanted reported severe mesh pain, bleeding, nerve damage, and neuro-muscular problems.
One of the more serious injuries linked with transvaginal mesh is organ perforation. This occurs when the eroding mesh’s sharp edges puncture nearby organs, such as the bowel or the bladder. Quite a few women developed chronic pelvic pain, which impaired their quality of life.
How Many Women Have Mesh Implants?
The number of women affected due to transvaginal mesh implants is staggering. Women in the U.S. aren’t the only ones affected due to this medical device. Notable instances of injuries arising due to transvaginal mesh are also observed in Australia. In Scotland, over 20,000 women had transvaginal mesh implants.
In the U.S. alone, more than 100,000 women have sued manufacturers on grounds such as negligence, defectively designing the product, or failing to warn them of potential consequences, notes TruLaw. Transvaginal mesh lawsuits are lodged against Coloplast, Boston Scientific, American Medical Systems, C.R. Bard, and Ethicon.
As for the recent transvaginal mesh lawsuit update, 95% of lawsuits have been resolved through jury verdicts or settlements.
Ethicon paid around $10 million to settle the claims of the state of Kentucky that it failed to disclose the risks associated with the use of its transvaginal mesh. C.R. Bard, on the other hand, has resolved most of its MDL cases. But, as of January 2024, a handful of federal cases remain in New Jersey multicounty legislation.
In March 2023, Boston Scientific agreed to pay $105 million to settle a class-action lawsuit, which an Australian federal court accepted.
While several factors influence the settlement amount, lawyers estimate that plaintiffs could receive anywhere between $40,000 and $450,000 in a transvaginal mesh lawsuit.
Is the Surgery Reversible?
Transvaginal mesh implants are designed to be permanent. That is why removing them is challenging. Normally, surgeons remove the mesh and place stitches if it becomes exposed in the vagina. This isn’t complicated and can be done under local anesthetic.
In the case of severe complications, full removal is required. Complete removal of transvaginal mesh requires hours of surgery. But, it poses a risk to nerves and surrounding organs, such as the colon and the bladder.
In certain cases, mesh removal worsens the incontinence, pain, and prolapse. For this reason, mesh removal isn’t an appropriate treatment for women.
To summarize, transvaginal mesh implants help treat urinary incontinence and pelvic organ prolapse. But, they are linked with a host of complications in women, including vaginal bleeding and organ perforation. Some women experience these issues soon after getting the implant, but it takes a while for others to develop them.
Those who have gotten mesh implants and are concerned about the side effects must consult a doctor as soon as possible. Meanwhile, if you’re planning to get a mesh implant to manage SUI or pelvic organic prolapse, non-surgical options such as kegel exercises are better than surgical treatments. Therefore, go for them.