A recent study published in the journal Obstetrics and Gynecology, said pelvic mesh should have been banned earlier than it was.
The research team was comprised of doctors from Weill Cornell Medical College-New York Presbyterian in New York, the University of Oxford in the UK, the Warren Alpert Medical School of Brown University in Rhode Island, and the Women & Infants Hospital in Providence, R.I.
They studied 54,194 women in the state of New York who had been implanted with transvaginal mesh to treat pelvic organ prolapse (POP). The study indicated those treated with the mesh had an 8.8% risk of reintervention surgery up to five years after the initial procedure. This was compared with 6.3% of the same size group who were treated differently than with pelvic mesh.
There was a 40% increased risk observed in all levels of hospitals performing POP procedures.
In 2017, both Scotland and the UK warned women about the risk of pelvic mesh. The UK National Institute for Health and Care Excellence concluded such procedures should be limited to research only. Additionally, Australia and New Zealand banned mesh that same year.
Yet, in 2008, the US Food and Drug Administration already had over 1,000 adverse events reported that were related to pelvis mesh. In both 2008 and 2011, the agency released public safety communications based on the reports. There were public panel meetings that took place in 2011 and 2019, which openly discussed the safety and effectiveness of pelvic mesh.
How did the FDA handle pelvic mesh?
“Our goal was to keep patients informed of the risks of these products while we moved through our multi-year regulatory process,” an FDA spokesperson said in an email exchange with MassDevice.
After elevating safety of mesh implants, the medical device was reclassified to a high-risk Class III, where it had previously been classified as a moderate risk Class II device. There were multiple premarket authorizations (PMA) which allowed the mesh to continue being marketed during the FDA’s review of the device.
“All along, the FDA has been transparent about our concerns with the public,” the spokesperson said.
The FDA requested post-market studies from mesh manufacturing companies in 2012. However, the researchers reported there was little participation from surgeons. The agency abruptly ordered manufacturers to halt production of mesh in April 2019. This was due to manufacturers lack of providing “reasonable assurance” of both effectiveness and longterm safety of mesh used for POP.
The report itself said, “The United States was late in the removal of mesh implants for POP despite the numerous safety warnings and adverse events reported from patients’ narratives”
“Even though transvaginal mesh has been removed from the market, our data suggest that the risk of mesh complications does not diminish over time and these women warrant close follow-up.”
What did the results say?
The new study found that 18.5% of those who had reintervention surgery were seen for mesh-related complications. The remaining people had reintervention related to new or recurrent prolapse, urinary complications, or others.
There had been a long-standing belief that mesh procedures helped reduce the recurrence of POP due to the support it provided. However, the results prove just the opposite.
Overall, there was a higher rate of POP surgery repeats in women with mesh (652 patients or 5.3%) than in women without the mesh (513 patients, or 4.2%). Mesh complications vary but may include: chronic inflammation, mesh shrinkage and embedding in scar tissue, infection, bleeding, pain during sexual intercourse, organ perforation, protrusion through the vaginal wall and urinary problems.
The researchers believe mesh erosion is an ongoing risk. In a study published in the Cochrane Review in 2016, only 8% of surgical reintervention was for mesh-related complications. That study followed 4,023 women in controlled trials.
Researchers from the new study said reintervention may only capture a portion of women, as mesh erosion or complications can also be managed in an office setting. “The rate of mesh complication may actually be underestimated..,” they said.
In conclusion, the researchers said, “Continued surveillance of mesh in POP repairs is essential to ensure safety for the women who have already been implanted.”
“Registries should include comprehensive information about the nature and burden of POP recurrence, different types of re-treatment, patient-reported outcomes, and information about implanting surgeons.”
Do you have a pelvic mesh lawsuit?
Mesh manufacturers have been paying out millions of dollars in settlements and legal judgments. If you have been the victim of pelvic mesh complications, you should contact the lawyers at Johnson//Becker. We offer a Free Case Evaluation and would be honored to speak with you.