The Food and Drug Administration (FDA) has expressed its concerns over some manufacturers that are marketing devices for vaginal rejuvenation as suitable for treating indications related to stress urinary incontinence (SUI), menopause or sexual function.
The statement released explained that although the FDA has cleared or approved energy and laser-based devices for addressing serious women’s health conditions, such as pre-cancerous or abnormal cervical and vaginal tissue, the safety of these devices has not been evaluated by the FDA for ‘vaginal rejuvenation’ treatments specifically.
Upon reviewing adverse event reports, the FDA warns that vaginal rejuvenation treatments can potentially cause vaginal burns, scarring and chronic pain.
The FDA stated, “The deceptive marketing of unproven treatments may not only cause injuries, but may also keep some patients from accessing the appropriate therapies to treat severe medical conditions.” The statement continued, “The FDA has serious concerns about the use of these devices to treat gynaecological conditions beyond those for which the devices have been approved or cleared.”
According to the FDA, it has recently been concentrating on advancing new policies to improve its oversight of device safety. As part of its Medical Device Safety Action Plan, the FDA claims it is committed to advancing women’s health and has begun to construct device safety registries.
As part of this work, the FDA states that it will continue to closely monitor reports of adverse events associated with vaginal rejuvenation procedures. Surgeon Miss Mayoni Gooneratne, who offers vaginal rejuvenation treatments in her clinic, said of the FDA’s statement, “The warning from the FDA comes at an important time, as there are now many vaginal rejuvenation brands out there and women need to know that the treatment they choose has been properly tested for safety.”