Kiwi women get vaginal tightening despite FDA alert
The safety of a laser device is under scrutiny. Cate Broughton reports.
Kiwi doctors and beauty therapists are performing vaginal rejuvenation treatments despite warnings from United States officials the procedure can burn and scar.
The treatment, made famous by US socialites the Kardashians, uses lasers and other energy transmitting devices to produce micro-lesions on the vaginal wall, triggering the production of collagen, restoring lubrication and tightening the tissue surrounding the vulva and vagina.
The Food and Drug Administration (FDA) warned the procedure was approved for removing genital warts and cancerous cells but not for vaginal ‘‘rejuvenation’’, stress urinary incontinence or vaginal dryness. Using them ‘‘may lead to serious adverse events, including vaginal burns, scarring, pain during sexual intercourse, and recurring/ chronic pain’’, the FDA said.
One 55-year-old woman, who did not want to be named, was treated by a laser device called the MonaLisa Touch, which is used for menopausal women suffering from atrophy, or vaginal dryness. Despite the FDA warnings, she would be lining up for a repeat treatment: it had made sex pleasurable again, she said.
New Zealand does not have a premarket assessment or approval process for medical devices. Instead, suppliers are required to list products on Medsafe’s Web-Assisted Notification of Devices database, Medsafe group manager Chris James said. No adverse events related to vaginal energy-based or laser devices had been reported.
Christchurch’s Oxford Women’s Health gynaecologist Simon Jones said the clinic introduced the MonaLisa Touch this year for symptoms of menopause. Vaginal atrophy affected 40 to 50 per cent of post-menopausal women, Jones said. Most could be treated with estrogen cream – but it wasn’t suitable for everyone.
Jones believed the procedure should only be offered by gynaecologists, and other providers were promoting it for stress urinary incontinence and cosmetic purposes, despite a lack of evidence.
Thirty-four peer-reviewed clinical trials had found the MonaLisa Touch was safe to treat vaginal atrophy and painful sex, Jones said.
Matt Moncrieff, the managing director of High Tech Laser – which distributes MonaLisa Touch in New Zealand – believed the FDA warning resulted from a proliferation of ‘‘copycat’’ devices that did not have the same degree of research behind them.
‘‘There’s been 40,000 treatments in Australia and NZ and no cases of scarring or burning. In the US there has been one million treatments and 15 reports for nine incidents.’’
Medical spa The Face Place has offered vaginal rejuvenation, tightening and treatment of stress urinary incontinence with a radiofrequency energy device ThermiVa for two years.
Founder Dr Catherine Stone said the treatment was ‘‘lifechanging for women with incontinence’’ and the spa had seen ‘‘absolutely no serious side effects’’.
‘‘We’ve found it really helpful for women with dryness, pain, as well as . . . we do use it for the tightening effect but the biggest effects we’ve seen would be the urinary incontinence side of things.’’
The treatment is lifechanging. Dr Catherine Stone The Face Place medical spa