New York, Aug 4 (IANS) The US Food and Drug Administration (FDA) has slammed all those devices being marketed for medical procedures like vaginal rejuvenation as “egregious” and causing “harm”, a statement said.
The regulatory body has found that a growing number of manufacturers were marketing such devices to women, claiming to treat conditions and symptoms related to menopause, urinary incontinence or sexual malfunction.
The procedures use lasers and other energy-based devices to destroy or reshape vaginal tissue.
However, “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”, said FDA Commissioner Scott Gottlieb.
The FDA found that the use of these devices caused numerous cases of vaginal burns, scarring, pain during sexual intercourse and recurring or chronic pain.
Countering an earlier clearance on laser and energy-based devices for treating serious conditions, including pre-cancerous cervical or vaginal tissue, as well as condylomas (genital warts), the FDA said at that time its safety and effectiveness had not been evaluated or confirmed for vaginal rejuvenation, the statement said.
Moreover, these devices are also being marketed to women who have completed treatment for breast cancer and are experiencing symptoms caused by early menopause, the regulatory body found.
“The deceptive marketing of a dangerous procedure with no proven benefit, including to women who’ve been treated for cancer, is egregious,” Gottlieb said.
“Today, we’re warning women and their healthcare providers that the FDA has serious concerns about the use of these devices to treat gynecological conditions beyond those for which the devices have been approved or cleared,” Gottlieb said.
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.
“Women considering treatment for vaginal symptoms should speak to their doctor about the potential and known benefits and risks of all available treatment options,” Gottlieb noted.