Energy-based laser devices have been used to help treat serious conditions like cancer and genital warts while also aiding in surgeries such as hysterectomies. These devices have helped many patients, but the manufacturers of these devices are promoting them for uses unapproved by the U.S. Food and Drug Administration (FDA). In July 2018, the FDA sent out a warning to doctors and patients regarding serious injuries reported from the dangerous medical devices. The FDA warns against using energy-based devices to perform vaginal rejuvenation or other vaginal cosmetic procedures.
Promoting Unapproved Uses
Manufacturers are touting energy-based devices as solutions for “vaginal rejuvenation;” however, this vague term is sometimes used to describe non-surgical procedures that treat various vaginal symptoms. Some of the symptoms vaginal rejuvenation claims to treat include:
- Vaginal laxity
- Vaginal dryness
- Pain during sexual intercourse
- Pain during urination
- Decreased sexual sensation
- Menopause symptoms
In the warning letter released to patients and doctors, the FDA stated, “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.”
Why Vaginal Rejuvenation Is Dangerous
Vaginal rejuvenation uses energy-based devices to burn or destroy vaginal tissue so it can be reshaped. There is no scientific evidence supporting manufacturer claims that these devices can improve vaginal health in any way. In fact, the FDA warns these devices can cause serious injuries, including “vaginal burns, scarring, pain during sexual intercourse, and recurring/chronic pain.”
Manufacturers Are Illegally Advertising These Devices
Manufacturers are only legally allowed to market devices for uses approved by the FDA. Unfortunately in the case of vaginal rejuvenation, manufacturers are choosing to break the law at the expense of patients. Patients who undergo vaginal rejuvenation procedures could suffer painful and permanent injuries. Victims deserve to hold manufacturers accountable.
Vaginal Rejuvenation Injury Attorneys
At Blizzard Law PLLC, we stand up to large medical device manufacturers for our clients. There is no adversary too big. If you or someone you love suffered burn injuries after a vaginal rejuvenation procedure, don’t wait to call the vaginal rejuvenation injury attorneys at Blizzard Law PLLC today. We have female lawyers readily available to discuss sensitive and personal issues. We can help you understand your legal rights and pursue compensation on your behalf.