If you or someone you love has undergone a vaginal “rejuvenation” procedure involving a vaginal laser and was injured, you may have rights. Please contact one of our attorneys to discuss your potential claim.
Our attorneys are investigating claims of adverse events resulting from the use of vaginal lasers for “rejuvenation” procedures, resulting in unintended side effects such as burning, scarring, or pain during sex.
“Vaginal rejuvenation” is a fairly new term generally used to describe non-surgical procedures intended to treat conditions related to vaginal discomfort, including dryness, itching, laxity, or atrophy, as well as pain during sex or urination. The term is not strictly or narrowly defined, according to the Food and Drug Administration (FDA), and the FDA has not cleared any device or laser for such a procedure at this time.
In a July 30, 2018 Safety Communication, the Food and Drug Administration (FDA) warned women considering elective vaginal “rejuvenation” procedures (and the health care providers who perform these procedures) to proceed with heightened caution, citing the absence of FDA clearance or approval for these procedures.
Originally designed and marketed for treatment of abnormal or pre-cancerous tissue and growths, energy-based devices that involve radiofrequency or laser technology have garnered FDA approval for general gynecological purposes. Growing in popularity, however, are cosmetic or “rejuvenating” non-surgical procedures that use these same energy-based devices to treat vaginal symptoms or conditions such as:
According to the FDA, the safety and efficacy of using energy-based devices for the above indications has not been determined. In fact, the FDA has not cleared or approved the use of these devices, which include lasers manufactured an sold by the following companies:
Side effects of vaginal “rejuvenation” procedures includes:
The FDA cautions potential patients that the use of energy-based devices for the treatment of these conditions, or any symptoms relating to menopause, urinary incontinence, or sexual function can lead to serious adverse events such as burning, scarring, pain during intercourse, and chronic pain. Examples of such adverse events are available for public review on the FDA’s Adverse Event Report Databases.
According to a statement issued by FDA Commissioner Scott Gottlieb, M.D., the FDA’s review of adverse event reports associated with these devices produced alarming results: “we have found numerous cases of vaginal burns, scarring, pain during sexual intercourse, and recurring or chronic pain… the full extent of the risks is unknown. But these reports indicate these procedures can cause serious harm.”
If you have undergone a cosmetic vaginal “rejuvenation” procedure such as the “Mona Lisa Touch” laser procedure or the “Thermiva” device and are experiencing symptoms such as those listed above, reach out to one of our attorneys today about your legal rights.
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