On July 30, 2018, the FDA issued a warning against the use of energy-based (most commonly radiofrequency or laser) devices utilized to perform vaginal rejuvenation procedures. These devices have been approved by the FDA for gynecological purposes such as the destruction of abnormal or pre-cancerous cervical or vaginal tissue and genital warts. However, several manufacturers of these devices have been aggressively marketing them to women for uses which are not approved by the FDA nor properly tested including:
- Cosmetic vaginal procedures/vaginal rejuvenation;
- Treatment of menopause related symptoms;
- Vaginal atrophy;
- Improvement in sexual function; and
- Improvement in urinary incontinence/pain.
Adverse events including vaginal burns, scarring, pain during intercourse and chronic pain have been reported.
Vaginal Rejuvenation procedures have become more popular in recent years, but the FDA warning highlights the complete lack of testing. As Dr. Scott Gottlieb, FDA Commissioner, noted, “the safety and effectiveness of these devices hasn’t been evaluated or confirmed by the FDA for ‘vaginal rejuvenation.’ In addition to the deceptive health claims being made with respect to these uses, the ‘vaginal rejuvenation’ procedures have serious risks.” The FDA notified seven (7) manufacturers of inappropriate marketing of their devices for vaginal rejuvenation. Those manufacturers included:
- Alma Lasers;
- BTL Aesthetics;
- BTL Industries;
- Sciton; and
The Unsafe Drug and Medical Device Team at Anapol Weiss is investigating vaginal rejuvenation cases on behalf of patients who underwent a laser treatment for vaginal rejuvenation/sexual or urinary health and suffered an injury.