Hologic warned over inappropriate marketing of vaginal rejuvenation procedures

Enlarge  Food and Drug Administration Commissioner Scott Gottleib is not

Enlarge Food and Drug Administration Commissioner Scott Gottleib is not

According to the FDA, these "energy-based devices" (i.e., lasers), destroy and reshape vaginal tissue. "These products have serious risks and don't have adequate evidence to support their use for these purposes", Gottleib said.

In some cases, women who've gone into early menopause after breast cancer treatments are opting for these interventions, but "the deceptive marketing of a unsafe procedure with no proven benefit, including to women who've been treated for cancer, is egregious", Gottlieb said.

The agency said treating such symptoms by applying energy-based therapies to the vagina may lead to serious adverse events, including vaginal burns, scarring, pain during sexual intercourse, and recurring/chronic pain.

As part of Monday's warning, the FDA announced it had notified seven companies about the "inappropriate marketing of their devices for "vaginal rejuvenation" procedures" including: Alama Lasers, BTL Aesthetics, BTL Industries, Cynosure, InMode, Sciton and Thermigen.

But the FDA wants women to look out for their own safety, too.

Statement from FDA Commissioner Scott Gottlieb, M.D., on efforts to safeguard women's health from deceptive health claims and significant risks related to devices marketed for use in medical procedures for "vaginal rejuvenation" [news release].

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Procedures marketed to improve a woman's "intimate health" using lasers or ultrasound are not only unapproved, but are also causing burns and other painful damage, the Food and Drug Administration said Monday.

Gottlieb is concerned that these procedures are aimed at women who had cancer treatment that caused early menopause, a fact he considers to be egregious and, adding that the manufacturers use "deceptive marketing of a risky procedure with no proven benefit". Needless to say that the FDA has yet to review, let alone recommend, these procedures. "But these reports indicate these procedures can cause serious harm", the FDA said. Answers from the companies have been sought within the next 30 days.

The idea is that the vaginal rejuvenation process will help boost sexual desire and sexual function, but there's just one problem: These claims are probably all BS, says Dr. Gupta.

Gottlieb also said he was concerned that deceptive marketing of these devices might prevent some patients from getting appropriate therapies for severe medical conditions. If the companies fail to respond, the FDA said, it will consider next steps, which might include "potential enforcement actions". The FDA has urged women to stop using these devices and report the issues to the FDA's adverse event reporting programme called the MedWatch.

In a statement, Jane Mazur, Hologic's vice president of global divisional communications, said that "Hologic has a strong track record of rooting our products in science and clinical evidence" and that it is "evaluating the letter in full and will collaborate with the agency to ensure all product communications adhere to regulatory requirements".

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