If you’ve seen the ads, heard the interviews, and read the reports, you may be under the impression that vaginal rejuvenation procedures are safe. But some aren’t. Procedures performed with energy-based devices like lasers and devices that use radio frequencies have not been approved by the FDA and women have reported serious injuries in connection with the use of these products. Contact us today to learn more about your rights and whether you are entitled to join any potential vaginal reshaping lawsuit settlement.
In fact, the FDA released a statement saying that these procedures can result in serious injuries such as:
- Vaginal burns
- Vaginal scarring
- Pain during sex
- Chronic or recurring pain
The FDA made clear in the statement that no devices being used in vaginal rejuvenation procedures have been reviewed or approved by the government watchdog agency, so the extent of the risks and dangers remain unknown at this time.
Warning Letters Issued
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The FDA also issued It Has Come to Our Attention letters to seven manufacturers who make, distribute, sell, and market devices for vaginal rejuvenation. These manufacturers are advertising their products as safe and effective, but offer little proof to back those statements, and they are not warning patients about the dangers of using these energy-based devices including being left with burns, scars, and pain. The letters gave the device makers 30 days to address the agency’s concerns while the next steps are considered.
These devices were being marketed as treatments for issues such as vaginal laxity, itching, dryness, and atrophy, painful urination, pain during sex, and for cosmetic reasons. But they were never cleared for these uses, nor have they presented clinical evidence for approval. These device makers are advertising these devices as solutions, but they aren’t informing women of the risks when they are used vaginally.
Doctors Recommend Staying with Proven Treatments
Doctors in Women’s Health are recommending that patients also demand the science behind the procedures they are considering and ensure the tools used during those procedures have been approved for that use. The American College of Obstetricians and Gynecologists responded to advertisements that the MonaLisa Touch was approved for the treatment of menopausal symptoms by issuing a Position Statement clarifying that these devices have not been approved by the FDA for vaginal rejuvenation procedures. The statement also reminded physicians of their ethical responsibilities to give their patients current and accurate information about the treatments and procedures they perform.
But some physicians are continuing to recommend these devices despite FDA warnings and investigations including plastic surgeons and dermatologists who are not necessarily trained in vaginal procedures and treatments.
We Can Help
Women who suffer serious injuries during vaginal rejuvenation procedures using one of these unapproved energy-based devices may be entitled to seek justice and compensation for their injuries. If you or a woman you love suffered burns or scars and was left with chronic or recurring pain after undergoing a vaginal rejuvenation procedure contact us now and learn more about vaginal rejuvenation device dangers, how we can help, and whether you are entitled to significant compensation for your injuries.