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Adverse event reports for vaginal rejuvenation described.


The use of energy-based devices for vaginal rejuvenation was implicated in nearly four dozen adverse event reports found in the agency's medical device adverse event reporting database, researchers report.

The 45 unique event reports, submitted to the Food and Drug Administration during October 2015-January 2019, described 46 patients in total, of whom 33 reported long-term effects including pain, numbness, and burning, said Jusleen Ahluwalia, MD, of the department of dermatology at the University of California, San Diego, and her coauthors. They included 31 that were reported by the patients, 8 reported by the manufacturer, 4 reported by the distributor, and 2 not specified.

These findings emphasize the need for clinical trials to evaluate the safety and efficacy of the lasers and radiofrequency devices that have been marketed and used for so-called vaginal rejuvenation procedures, they wrote in Lasers in Surgery and Medicine. The coauthors are Arisa Ortiz, MD, also with the University of California, San Diego, and Mathew M. Avram, MD, director of the Massachusetts General Hospital Dermatology Laser & Cosmetic Center, Boston. "Randomized studies are necessary to compare these therapies with standard modalities and to establish the safety of these devices," they wrote.

In July 2018, the FDA issued a safety communication alerting patients and health care providers that the safety and effectiveness of energy-based devices has not been established for procedures described as "vaginal rejuvenation." In a statement, FDA commissioner Scott Gottlieb, MD, referred to "deceptive health claims and significant risks" related to devices marketed for those procedures. In a November 2018 update, the FDA said that some manufacturers contacted by the agency regarding concerns over inappropriate marketing had "responded with adequate corrections."

In their report, Dr. Ahluwalia and her associates noted that "vaginal rejuvenation" is an ill-defined term that may encompass a variety of procedures related to tightening; dyspareunia; dysuria; urinary incontinence; vulvar issues including irritation, dryness, and atrophy; and orgasmic dysfunction.

They found a total of 58 records in their review of the Manufacturer and User Facility Device Experience database, of which 25 were reported prior to the FDA's July 2018 statement. Of 45 unique event descriptions found in those records, 39 were categorized as patient-related injuries, while 2 were operator-related injuries, 2 were device malfunctions, and 2 were not specified.

Pain was the most commonly reported adverse event, accounting for 19 reports, while 11 patients reported numbness or burning.

Among the laser- and energy-based devices specifically described in the 39 patient-report injuries, the MonaLisa Touch had the highest number of adverse event reports (16). "However, this may be reflective of length of time bias as it is one of the first devices utilized to promote vaginal rejuvenation," the authors pointed out.

In light of these findings, they advised clinicians to ask patients about their reasons for seeking vaginal rejuvenation procedures. "Normal variety of female genital appearances should also be reviewed when patients express cosmetic concerns," they added. Concerns related to genitourinary syndrome of menopause "or optimizing sexual function may be alleviated by exploring nonprocedural, conservative approaches, such as hormonal creams, if not contraindicated, and/or counseling," they noted.

The authors provided conflict of interest disclosures related to Zalea, Inmode, Cytrellis, Zeltiq Aesthetics, Soliton, Sciton, Allergan, and Sienna Biopharmaceuticals, among others.

Device-related adverse events can be reported to the FDA's Medwatch program.

SOURCE: Ahluwalia J et al. Lasers Surg Med. 2019 Mar 29. doi: 10.1002/lsm.23084.


Caption: Dr. Ortiz

Caption: Dr. Avram

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Title Annotation:LASERS
Author:Bowser, Andrew D.
Publication:Dermatology News
Date:May 1, 2019
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