Medicine

Hologic warned over inappropriate marketing of vaginal rejuvenation procedures

August 03, 2018 11:10·
The “safety and effectiveness” of procedures promising to treat vaginal conditions related to menopause is unclear the U.S. Food and Drug Administration warned Monday

The “safety and effectiveness” of procedures promising to treat vaginal conditions related to menopause is unclear the U.S. Food and Drug Administration warned Monday

The devices are not created to work on large areas or for reshaping procedures such as those performed during vaginal rejuvenation. He also said that officials have found "numerous cases" of serious harm.

The "safety and effectiveness" of procedures promising to treat vaginal conditions related to menopause is unclear, the U.S. Food and Drug Administration warned Monday.

United States regulator the FDA says it will take action if deceptive marketing of the "dangerous procedure with no proven benefit" continues. According to the FDA, it's received a number of complaints about burns and other damage arising from these treatments. In these cases, the FDA had not reviewed or approved the used devices for the objective of 'vaginal rejuvenation'.

"The treatment of these symptoms or conditions 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", FDA said.

However, it is usually recommended for small-scale situations such as "destroying abnormal, pre-cancerous cervical or vaginal tissue as well as genital warts".

The FDA has notified Alma Lasers, BTL Aesthetics, BTL Industries, InMode, Cynosure, ThermiGen and Sciton over "concerns about inappropriate marketing of their devices for "vaginal rejuvenation" procedures", and expects them to address the issues raised by the agency within 30 days.




"To date, we have not cleared or approved for marketing any energy-based devices to treat these symptoms or conditions, or any symptoms related to menopause, urinary incontinence or sexual function", the FDA said. If its concerns are not addressed, the agency could take enforcement action.

The companies involved say they are reviewing the warning letters from the FDA, which advises them to stop promoting the treatments. We've also established the Women's Health Technologies Strategically Coordinated Registry Network (CRN) to provide more complete evidence in clinical areas that are unique to women, such as uterine fibroids and pelvic floor disorders.

If you suffered any adverse effects associated with these procedures, the FDA wants you to file a report through MedWatch.

The FDA is warning consumers against serious risks of some "vaginal rejuvenation" devices, and a lack of evidence to support their uses for this goal. "We are evaluating the letter in full and will collaborate with the agency to ensure all product communications adhere to regulatory requirements".

Women who may not be candidates for certain FDA-approved treatments to relieve vaginal dryness, and who are seeking alternative nonhormonal options, may be particularly drawn to "vaginal rejuvenation" devices, ' according to the agency.

Discuss the benefits and risks of all available treatment options for vaginal symptoms with your health care provider.

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