VAGINAL “rejuvenation” laser treatments introduced to Australia without clinical trials could be the next major women’s health scandal, say specialists and academics in an extraordinary warning comparing the risks of vaginal laser treatments with the pelvic mesh scandal.
Doctors have been warned to “consider the potential medico-legal consequences” of using laser treatments because of the lack of evidence supporting their use for “vulvovaginal atrophy”, and the Urological Society of Australia and New Zealand has asked health regulator the Therapeutic Goods Administration to review the treatments, said an article in the Medical Journal of Australia on Monday.
Queensland University urogynaecologist Christopher Maher, who sounded the alarm on pelvic mesh more than a decade before it became an Australian and global scandal, said the rise of carbon dioxide laser therapy to treat vaginal atrophy “causes some anxiety for me”.
“We have been through all this within the past 10 years with transvaginal meshes and we’re still going through it,” Associate Professor Maher said.
“Everyone wishes we had done things differently (with transvaginal mesh) but we are just repeating the same problems again.”
Monash University Professor of Women’s Health Susan Davis said the rise of laser therapy to treat menopausal symptoms was “extremely concerning”.
“While the jury is out, I believe that using this treatment in the community, at a cost to the individuals, is taking an uncertain treatment too far,” Professor Davis said.
The laser treatments are being offered in specialist, general practice and cosmetic medicine settings. The MJA article said the procedure costs more than $500 per treatment, with three initial treatments followed by annual treatments. It is unknown how many are being performed in Australia because they cannot be tracked by a specific Medical Benefits Schedule item number. A Senate inquiry into the pelvic mesh scandal heard evidence the number of women receiving mesh could not be determined for the same reason.
NSW gynaecologist Dr Richard Reid, who retired before he was deregistered in September after multiple women experienced serious complications following pelvic mesh surgery by him, promoted “vaginal ageing” laser procedures in 2016 while under investigation by the NSW Health Care Complaints Commission.
Dr Reid was suspended in America in the 1990s after findings of incompetence involving women’s pelvic laser surgery.
In the MJA article on Monday Professor Davis, University of Melbourne Professor of Obstetrics and Gynaecology Martha Hickey, and Queensland gynaecologist Dr Melissa Buttini said the increasing use of laser therapy to treat menopausal syndromes was extremely concerning.
The TGA cleared laser therapy for “incision, excision, vaporization and coagulation of body soft tissues” during oral surgery, dermatology, ear, nose and throat surgery and gynaecology, but it was not specifically listed to treat menopausal syndromes. The TGA advised the Newcastle Herald in 2016 that medium or medium-high risk laser devices were approved on the basis of European certification.
Professor Davis called on the Royal Australian College of Obstetrics and Gynaecology (RANZCOG) to update its position on laser treatments for vaginal atrophy after the American Food and Drug Administration in July said it had “serious concerns” over the use of carbon dioxide laser therapy for “vaginal rejuvenation”.
RANZCOG’s website notes there is little high-quality evidence that laser therapy is effective, enhances sexual function or improves self-image. Complications included scarring, adhesions, permanent disfigurement, infection and difficult or painful sexual intercourse.
Professor Hickey said it was premature to offer women vaginal laser treatment for dryness or any other symptom until there was evidence to show it worked and was safe, and she had current ethical concerns about use of the treatment, the MJA article said.
“Currently we do not have this evidence,” she said.
The MJA article noted a trial of the MonaLisa Touch laser treatment at the Royal Hospital for Women at Randwick.
Until results of the trial and others outside Australia are known “it seems foolish to be using a technique that has the potential to do harm”, Professor Hickey said.
“For women who do require treatment, the best evidence we have currently, is that low dose oestrogen is the most effective treatment for vaginal dryness and is safe for the great majority of women.”
She warned that clinicians who had purchased expensive equipment to perform laser therapy had a conflict of interest in recommending it.
There have been reported cases of burns, scarring and pain associated with the use of the devices.Urological Society of Australia and New Zealand.
In August the Urological Society of Australia and New Zealand backed the American FDA’s warning about “deceptive health claims” relating to lasers and their use for reshaping vaginal tissue, menopause and improving sexual function.
“While the devices have been approved for use in the treatment of serious conditions such as the destruction of abnormal or pre-cancerous cervical or vaginal tissue as well as genital warts, the safety and effectiveness of these devices has not been evaluated for ‘vaginal rejuvenation’,” the society said.
“There have been reported cases of burns, scarring and pain associated with the use of the devices.”
Society special advisory group leader on female urology Associate Professor Vincent Tse said urologists were concerned by patients being referred to manage complications after ‘vaginal rejuvenation’ procedures.
“This is a technology for which there is limited scientific data to support its use for claims associated with vaginal atrophy or incontinence and the FDA has acted wisely. We would encourage the TGA to also review claims made in Australia regarding this technology,” Associate Professor Tse said.
The TGA was contacted for comment.