Hologic warned over inappropriate marketing of vaginal rejuvenation procedures

Monday, the FDA issued a statement warning that some of the "vaginal rejuvenation" treatments on the market can come with unsafe side effects, like vaginal burns, scarring, and pain.

Experts say the "therapies", offered by some private clinics in the United Kingdom and the USA, pose a serious risk of burns, scarring and recurring pain.

As part of our efforts to promote women's health, the FDA has cleared or approved laser and energy-based devices for the treatment of serious conditions like the destruction of abnormal or pre-cancerous cervical or vaginal tissue, as well as condylomas (genital warts).

"As a leader in women's health, Hologic has a strong track record of rooting our products in science and clinical evidence, so we take the contents of this letter seriously", Jane Mazur, a representative for Hologic, Inc., said in a statement.

"We are deeply concerned women are being harmed", said Gottlieb, in a press release.

"The FDA has serious concerns about the use of these devices to treat gynecological conditions beyond those for which the devices have been approved or". Thus, the full extent of the risks is unknown.

The new laser and ultrasound devices are being marketed as safer, but the FDA said they could be harmful.

The FDA has even sent warning letters to seven companies that make these devices-including Cynosure Inc's MonaLisa Touch and Thermigen, Inc's THERMIva-asking the companies to either remove statements linked to nonsurgical vaginal rejuvenation or provide them with backup for those claims. "If our concerns are not addressed, then the FDA will consider what next actions, including potential enforcement actions, are appropriate". They FDA has noted that these treatments are sold to women who have been treated for breast cancer early and experience menopausal symptoms.

The deceptive marketing of unproven treatments may not only cause injuries but may also keep some patients from accessing appropriate, recognized therapies to treat severe medical conditions.

The Food and Drug Administration is cracking down on manufacturers promising "vaginal rejuvenation", saying it could have serious side effects.

In a move to improve their oversight of such devices, the FDA has also started building device safety registries.

The American College of Obstetricians and Gynecologists has been cautioning against surgical "rejuvenation" procedures for more than a decade. 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. Dr. Cheryl B. Iglesia, director of the section of female pelvic medicine and reconstructive surgery at MedStar Washington Hospital Center, said the laser technology held promise but more study was needed to understand the safety as well as which patients the devices might help.

However, these devices have not been approved for so-called vaginal rejuvenation.

Vanessa Coleman

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