Kiwi women get vag­i­nal tight­en­ing de­spite FDA alert

The safety of a laser de­vice is un­der scru­tiny. Cate Broughton re­ports.

Sunday Star-Times - - NEWS -

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

Newspapers in English

Newspapers from New Zealand

© PressReader. All rights reserved.