Australian Safety Advocates: Pelvic Mesh Issues are Under-Estimated

In Pelvic Mesh Survey, 58% of Women Report Problems

Australia’s Health Issues Centre (HIC), a consumer health advocacy group, says that transvaginal mesh problems in the country are under-estimated. The group released this leading view after conducting an online Facebook survey addressed to thousands of Australian women implanted with pelvic mesh, which is used to treat pelvic organ prolapse and stress urinary incontinence. In total, 58 percent of women surveyed say they suffered adverse events related to transvaginal mesh, including chronic incontinence, abdominal pain, and pain during intercourse.

The transvaginal mesh lawyers at Parker Waichman LLP are well-versed in transvaginal mesh litigation. The firm, which has decades of experience in medical device litigation, continues to offer free legal consultations to individuals with questions about filing a transvaginal mesh lawsuit.

According to an HIC press release, 1,250 women completed the survey in three weeks; 58 percent report adverse events. Among these, a quarter say that pelvic mesh problems have affected their personal relationships or marriages, HIC reports. Only 38 percent of survey takers felt they made an informed decision when agreeing to the pelvic mesh implant.

Among women who reported seeking medical intervention for transvaginal mesh problems, 40 percent said the problems remained unchanged and 11 percent said issues became worse. Slightly more than 10 percent said issues improved with medical assistance. The remaining 39 percent were told that nothing could be done, according to survey results.

HIC CEO Danny Vadasz commented on the results of the survey, stating, he does not know ‘how much of the iceberg has been revealed’. He noted that the survey received roughly 100 responses daily.

“Even if we were to receive no further responses, I think we have already demonstrated that this is a significant public health problem which has been grossly under-estimated – in terms of numbers of women as well as the severity of resultant health problems,” Vadasz said, according to the HIC press release.

“What we are seeing is a catastrophic failure at all levels of the health system to protect the well-being of thousands of women – the lack of due diligence by the TGA in approving the device given the risks; culpability of manufacturers who despite plenty of evidence of adverse reactions overseas, continue marketing their products; the government which does not have a central register of how many procedures have occurred and how many products have been sold and finally, those surgeons who continue to practise the procedure without informing their patients of the risks and the irreversibility of the implant.”

“Clearly a lot of questions need to be asked!”

According to the HIC release, the transvaginal mesh survey consists of the following questions:

• Have you undergone a transvaginal mesh, tape or sling implant as treatment for urinary incontinence or pelvic organ prolapse?
• Do you continue to have undiagnosed symptoms of chronic abdominal pain or urinary incontinence?
• Do you feel you were fully informed before agreeing to the procedure?
• Did the procedure satisfactorily resolve your health concerns?
• Could you specify any adverse impacts you may have experienced?
• How would you rate this adverse impact – discomforting, severe, debilitating, unendurable, none of these.
• Have you sought medical assistance to rectify the problem?
• Did your doctor/specialist confirm a causal relationship between your symptoms and the mesh implant?
• If you were offered remedial treatment, did it change your condition?

Transvaginal Mesh Injuries and Lawsuits

Parker Waichman notes that transvaginal mesh has become a controversial medical device in recent years, leading to thousands of lawsuits. In the United States, court records show that roughly 80,000 pelvic mesh lawsuits have been filed against various device makers. The U.S. Judicial Panel on Multidistrict Litigation (JPML) has created multidistrict litigations (MDLs) against: Boston Scientific, C.R. Bard, Ethicon, Neomedic, Cook Medical, Coloplast and American Medical Systems. A class action lawsuit has also been filed against Caldera in California.

Recently a Philadelphia jury awarded a $20 million verdict to a transvaginal mesh plaintiff. The lawsuit was filed on behalf of a New Jersey woman implanted with the TVT-Secur mesh. The suit alleges that the mesh caused chronic vaginal pain, pelvic floor spasms and permanent urinary dysfunction. According to the lawsuit, the plaintiff underwent three surgeries to correct her pelvic mesh injuries but pieces of the device remain in her body.

The award consisted of $2.5 million in compensatory damages and $17.5 million in punitive damages. Two other pelvic mesh verdicts were handed down against J&J in Philadelphia County Court’s mass tort program, totaling $26 million.

Plaintiffs suing over transvaginal mesh allege that the device is defective. One common alleged complication is mesh erosion, where the mesh implant moves through the tissues of the vagina. This painful complication can lead to organ perforation, severe pain, and other symptoms. Some women undergo surgery to remove the embedded mesh, but the procedures are often unsuccessful.

The U.S. Food and Drug Administration (FDA) approved transvaginal mesh through 510(k), a fast-track process that allows devices onto the market without substantial clinical testing for safety or efficacy. Manufacturers are only required to show that their products are “substantially equivalent”, or as safe as, a previously approved device.

In light of safety concerns, the FDA has reclassified pelvic mesh from “moderate-risk” to “high-risk.” The new classification means that transvaginal mesh can no longer be approved through 510(k); the products must now go through the FDA’s stricter premarket approval (PMA), which requires clinical data for safety and efficacy.

In 2008, the FDA said the most common transvaginal mesh complications include:

• Mesh erosion
• Infection
• Pain
• Urinary problems
• Recurrence of prolapse
• Incontinence

Other pelvic mesh adverse events included bowel, bladder and blood vessel perforation. The FDA said at the time that transvaginal mesh injuries were serious but rare. In 2011, regulators amended this and clarified that transvaginal mesh complications were “not rare”. The agency further stated that pelvic mesh may present additional risks compared to non-mesh methods for treating pelvic organ prolapse.

Filing a Transvaginal Mesh Lawsuit

If you or someone you know suffered injuries related to the use of transvaginal mesh implants, you may have valuable legal rights. Our transvaginal mesh lawyers offer free, no-obligation case evaluations. For more information, fill out our online form or call 1-800-YOURLAWYER (1-800-968-7529).