FDA Warns that Vaginal Rejuvenation Possibly Unsafe
The U.S. Food and Drug Administration recently raised awareness among patients and physicians about controversial vaginal ‘rejuvenation’ treatments. The FDA warned patients about how these treatments lack certification to be completely safe. Moreover, the claims the brands make are false. The FDA called out the seemingly harmless treatment for causing disruptive side effects. Moreover, they released letters to seven companies, addressing their questionable marketing practices.
The Harmful Effects of Vaginal Rejuvenation Treatments
The FDA released a safety message to medical practitioners and patients. The message communicated that the devices received approval for treating such issues as abnormal vaginal tissue. However, brands marketed them as being helpful for treating menopause-related problems, like vaginal discomfort during intercourse and dryness.
In one particular statement, the FDA expressed concern over the implementation of these devices. The main reason for this concern is about the devices’ ability to address gynecological conditions that fall beyond the scope of approval.
The FDA backs their claims by referring to published medical literature, journals, and reports of adverse events. The literature describes the negative effects of using such radio frequency and laser-based devices. These include chronic pain, permanent scarring, and vaginal burns.
The FDA did have the authority to dispatch formal warning letters to device-making companies but did not act upon it. Hopefully, their announcement and safety messages will prove enough to stop the marketing of unproven therapies. Hence, they might be able to protect a vulnerable audience, which includes menopausal women.
Misleading Promotional Tactics
A spokesperson for the agency defined the practice of deceptive marketing of a potentially harmful procedure is grossly conspicuous. The brand’s claim that the procedure is beneficial for women dealing with cancer is bogus.
The letters sent to device making brands carried a tone similar to those of ‘it has come to our attention’ notices. In these kinds of formal notices, the FDA discusses the marketing tactics it has come to know about. Moreover, they state how it is unaware as to any approvals regarding the device being in use for the conditions it claims to address. Most importantly, the purpose of the letters is to elicit a response from the concerned companies.
The Companies Involved
Of the seven letters released on Monday, one went to Cynosure Inc., a Massachusetts-based company that sells the laser treatment, ‘MonaLisa Touch’. In the letter, the FDA overviewed the specific issues that their product received approval for. These include vaporization and incision of weaker tissue. It goes on to explain that the brand is promoting MonaLisa Touch as ‘clinically proven’ for treating painful menopausal symptoms, such as intimacy. However, the product is yet to undergo sufficient testing.
Alma Lasers, a company based in Illinois, also received a letter from the FDA, which discussed their device, FemiLift. The product originally received approval for treating problems of soft tissue. However, misleading promotional practices claim that it can manage vaginal irregularities.
The other five recipients of the FDA’s letters include Thermigen Inc., Sciton Inc., and BTL Industries Inc., based in Texas, California, and Massachusetts respectively. The other two companies are in Israel, namely BTL Aesthetics and Inmode MD Ltd.
The Initial Decision on Such Treatments
Talks about vaginal rejuvenation therapies have circulated among many patients over the years and allowed companies to create a lot of momentum. However, in the FDA’s Monday announcements, they cited an American College of Obstetricians and Gynecologists’ committee opinion from 2007. Moreover, it stated a single verdict: there is no evidence to establish the efficacy of vaginal rejuvenation treatments. They restated this opinion last year.
This led to many questions arising regarding whether there were any FDA-approved treatments for conditions that the companies claimed to manage. A spokesperson explained that there are certain hormonal treatments approved by the FDA to address problems like vaginal dryness and sexual comfort. However, the statement also explained that not all women are suitable to follow this treatment.
At The Eichholz Law Firm, our dangerous device attorneys are here to help. If you or a loved one has suffered severe health issues from these procedures, please contact us today.