‘Vaginal Rejuvenation’ Devices Have Serious Side Effects, Unproven Claims: FDA
The Food and Drug Administration is cracking down on manufacturers promising "vaginal rejuvenation," saying it could have serious side effects.
Plus, these devices might even not be effective in delivering its claims.
FDA Warns Women Of Vaginal Rejuvenation Devices
In an official statement issued by the agency, Scott Gottlieb, FDA commissioner, says they are recently aware of an increasing number of companies claiming that their products provide vaginal rejuvenation to women. These are marketed to treat symptoms related to menopause, urinary incontinence, and sexual function.
"The procedures use lasers and other energy-based devices to destroy or reshape vaginal tissue," Gottlieb wrote in the statement. "These products have serious risks and don't have adequate evidence to support their use for these purposes. We are deeply concerned women are being harmed."
The FDA clarifies that they have approved laser and energy-based devices for use to treat serious conditions such as genital warts.
However, these devices have not been approved for so-called vaginal rejuvenation. FDA has not yet approved them in dealing with vaginal dryness, itching, laxity, or for sexual dysfunction.
Unfortunately, manufacturers are making these deceptive health claims to women, particularly those who are experiencing early menopause or who just completed breast cancer treatment.
The use of these vaginal rejuvenation devices has been found to cause side effects including vaginal burns, scarring, pain during sexual intercourse, and recurring or chronic pain.
"The deceptive marketing of unproven treatments may not only cause injuries but may also keep some patients from accessing appropriate, recognized therapies to treat severe medical conditions," Gottlieb continues.
He added that women should speak to their healthcare provider for help in dealing with their issues.
FDA Takes Action
According to Gottlieb, the FDA has already expressed its concern to seven manufacturers who have been inappropriately marketing their devices. Alma Lasers, BTL Aesthetics, BTL Industries, Cynosure, InMode, Sciton, and Thermigen have all been contacted already. The agency is requesting the companies to address their concerns within one month.
In a move to improve their oversight of such devices, the FDA has also started building device safety registries.
What The Manufacturers Are Saying
Hologic, Inc., who owns the company Cynosure that markets the Mona Lisa Touch laser, addressed a reviewer who says she developed debilitating bladder pain after using the device.
"[We have] a strong track record of rooting our products in science and clinical evidence so, we take the contents of this letter seriously," Hologic, Inc. wrote in an e-mail to CNN. "We are evaluating the letter in full and will collaborate with the agency to ensure all product communications adhere to regulatory requirements."