Back in 2008, uproar started among women who had used a urogynecological or transvaginal mesh to treat conditions like pelvic organ prolapse and urinary stress incontinence. The former is a painful condition in which one or more organs slide down (from their regular position) towards the vagina.
This will lead to symptoms like bulge or pressure on the vagina, pain in the lower back, vaginal spotting, and the need to shift the protruding organ to poop or pee. As for the latter, it is a bothersome condition in which the woman suddenly loses control due to intra-abdominal pressure.
Its common symptoms are urine leakage during laughing, sneezing, bending over, exercising, or lifting something heavy. Each of these disorders usually occurs due to weakened muscles (pelvic and urinary sphincter) during childbirth.
Suffering from these conditions can be bad enough. What if the alleged cure turns out to cause additional health problems? This is exactly what the transvaginal mesh lawsuit is all about. In this article, we will look at this litigation’s outcome from legal and healthcare viewpoints.
Premise for the Litigation and Defendants Involved
This litigation has been ongoing since 2008 but was converted into a class-action multi-district litigation in 2012. Women have complained that the vaginal meshes turned out to be defective, thus causing other health complications.
Many of these not only impact one’s physical well-being, but also their emotional health. Let’s look at each complication to understand the litigation’s premise in detail.
- Mesh erosion – In some cases, the mesh eroded, cutting through the vaginal tissue or surrounding organs. This required additional surgeries to repair tissue tearing.
- Infection – Many women complained of developing an infection, which called for surgery or antibiotic drug treatment.
- Organ perforation – There were cases where the mesh punctured surrounding organs like the bowels or bladder. This caused an emergency for surgery.
- Pain and discomfort – In general, women filing the transvaginal mesh lawsuit have experienced varying levels of pain, either during sexual intercourse or simply while walking or sitting.
- Vaginal shrinkage and scarring – The vaginal tissue was found to be shrunk or scarred in some cases, causing extreme pain.
- Urinary problems – Some women repeatedly developed infections in their urinary tract.
- Recurrence of original conditions – Some women ended up suffering from relapses of urinary stress incontinence or pelvic organ prolapse. Such recurrences demanded further surgery and treatment.
According to TruLaw, the jury has taken into consideration the emotional/psychological distress caused due to the physical injuries and additional treatments.
Some primary defendants involved in the transvaginal mesh litigation include Ethicon, Coloplast, C.R. Bard, American Medical Systems, and Boston Scientific.
FDA Warnings and Mesh Alternatives
Apart from the personal injuries, plaintiffs have also sued transvaginal mesh manufacturers for their deceptive practices. In other words, companies like Boston Scientific and Coloplast were aware of their device defects (along with the repercussions).
Even then, they chose to put profits over vulnerable women and unsuspecting healthcare providers. The Food and Drug Administration (FDA) confirmed these claims in 2021. The agency stated that transvaginal mesh manufacturers have failed to demonstrate reasonable effectiveness and safety of their devices.
In 2021 itself, the vaginal mesh was classified as a Class III medical device (involving high risk). In October 2022, the agency gave a further verdict that the transvaginal mesh device does not show a favorable benefit-risk profile. This means it was clear that the cure was worse than the conditions it was designed to treat.
An interesting thing to note (from the healthcare viewpoint) is that the transvaginal mesh was banned by the FDA in 2019. This was especially done for women suffering from pelvic organ prolapse. Now, the question that arises is what can be used instead of mesh for prolapse.
Thankfully, medical science has discovered alternative treatments in the form of native tissue repair, pubovaginal sling, and biological graft repair to treat this condition. These are surgical methods to reverse the damage that is safe and effective (with functional benefits lasting over 10 years).
Average Settlement Amounts and Their Timeline
Since the litigation started in 2008, defendants in the transvaginal mesh lawsuit have lost trials (as a part of the MDL) and paid millions in settlements (billions in some cases). For instance – Ethicon had to pay $11 million in verdicts as a New Jersey court jury found it guilty of the allegations.
The same company paid an additional $10 million to the state of Kentucky for violating its Consumer Protection Act. Even as of January 2024, 201 cases are pending against this defendant. Similarly, C.R. Bard has also had to make multiple huge settlements over the last decade.
These include $3.6 million in 2012, $2 million in 2013, $21 million in 2014, $200 million in 2015, and $60 million in 2020. The others have also started settling lawsuits, with Coloplast having fewer pending cases, as compared to the rest.
It’s important to mention that the transvaginal mesh lawsuit is no longer a class-action MDL, as 95% of the cases have been settled. This does not mean that lawyers are not accepting any more filings.
The only difference now is that the new cases will be separately handled by the respective district courts. This is because the plaintiff’s counsel now has a clear idea of the settlement amount an individual case can expect. On average, payouts may vary between $40,000 and $450,000.
As we close, let’s briefly touch upon those who can qualify for a transvaginal mesh lawsuit filing. Any woman who has suffered one or more health complications listed above as a result of a vaginal mesh implant is eligible to file this lawsuit.
However, one should keep in mind the statute of limitations, which extends from one to four years before the injury is diagnosed. Also, there may be attorneys limiting case acceptance to those who recently had a transvaginal mesh removal or revision surgery.
Only a qualified lawyer will be able to determine a plaintiff’s qualification status by asking the right questions. These include when the implant was removed and when the victim started experiencing injury symptoms.
