The Chief Medical Officer for the Republic of Ireland has announced the temporary suspension of all transvaginal mesh procedures for the time being, citing “understandable public and patient anxiety” regarding the safety of the controversial implants.
The announcement comes just weeks after the United Kingdom’s National Health Services NHS) announced its own temporary transvaginal mesh ban.
“There is understandable public and patient anxiety about the ongoing safety of mesh devices following the considerable publicity that this issue has received and this has been heightened by recent developments in the NHS,” Simon Harris, Ireland’s Chief Medical Officer said in a statement issued earlier this week. “A pause on the use of mesh procedures, pending confirmation by the Executive that the key recommendations below have been implemented, is now considered proportionate and necessary to provide public assurance that these procedures are being carried out in accordance with internationally accepted good practice.”
The suspension will remain in place until Ireland’s Health Service Executive (HSE) is able to implement recommendations regarding surgical training, informed consent, and the development of an agreed dataset on mesh procedures.
Harris was careful to note that the “pause” on transvaginal mesh procedures is not a blanket ban, as the implants may be the only viable treatment option for some patients.
Transvaginal mesh is used to treat women suffering from pelvic organ prolapse or stress urinary incontinence.
In 2008, the U.S. Food & Drug Administration (FDA) issued a public safety communication warning that transvaginal mesh implants had been associated with more than 1,000 reports of mesh erosion, organ damage, chronic pain, and other life-changing complications.
The FDA updated its warning in 2011, after the number of reported complications tripled. The agency also warned that injuries following prolapse repair surgery with transvaginal mesh were not rare, a reversal of the position it had taken in 2008.
In 2016, the agency reclassified transvaginal mesh indicated for pelvic organ prolapse surgery as high-risk medical devices, subjecting the implants to increased regulatory scrutiny. Among other things, new transvaginal mesh devices can no longer be approved via the FDA’s 510(K) program, which had previously allowed the implants to come to market without undergoing human clinical trials.
Since 2008, tens of thousand of women have filed transvaginal mesh lawsuits against American Medical Systems, Inc., C.R. Bard, Inc., Ethicon, Inc., and other device manufacturers. Numerous cases have already gone to trial, with some juries awarding multi-million verdicts to plaintiffs. Several defendants have also agreed to settle hundreds of claims.