Some women experiencing incontinence or post-menopausal painful sex have been turning to “vaginal rejuvenation” treatments in an effort to alleviate their symptoms. However, a new warning from the Food and Drug Administration (FDA) has suggested women stay away from these procedures as they haven’t yet been properly tested or approved by the FDA yet. In addition, there are many reports of women being injured by these procedures.
In particular, the FDA was concerned about laser treatments as they have been known to potentially cause “serious adverse events, including vaginal burns [and] scarring.” As a result of this, women may end up experiencing more pain during sex than before the rejuvenation treatment.
FDA Commissioner Scott Gottlieb issued the following statement about these vaginal rejuvenation procedures.
“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. 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.”
Two reports have been received by the FDA from manufacturers as well as dozens of reports from patients in relation to adverse effects as a result of vaginal rejuvenation procedures. As a result of this, the FDA has sent out seven letters to manufacturers in regard to “inappropriate advertising” as well as advising doctors against the procedures, according to CNBC.
The procedures also go by various names including “designer vaginoplasty,” “revirgination,” or “G-spot amplification.” In addition, women are also likely paying for these procedures out of their own pockets as they are not usually covered by insurance.
The FDA is also concerned that women are turning to these procedures rather than accessing “appropriate, recognized therapies,” according to Gottlieb.
“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 laser devices used in vaginal rejuvenation are cleared for some medical uses. However, it is usually recommended for small-scale situations such as “destroying abnormal, pre-cancerous cervical or vaginal tissue as well as genital warts.” The devices are not designed to work on large areas or for reshaping procedures such as those performed during vaginal rejuvenation.
In addition, these treatments are also being marketed erroneously to women who have had cancer.
“The deceptive marketing of a dangerous procedure with no proven benefit, including to women who’ve been treated for cancer, is egregious,” Gottlieb said.
According to CNBC, the American College of Obstetricians and Gynecologists recommends “doctors inform patients about the lack of data supporting the efficacy and potential complications of vaginal rejuvenation and other similar procedures.”
So, for women who are experiencing incontinence or painful sex as a result of menopause, the best advice is to speak to your doctor about possible procedures which do work and to avoid vaginal rejuvenation procedures until more serious testing has been done.