Product News and Recalls

As FDA Rails Against ‘Vaginal Rejuvenation’ Doctors Say Not So Fast

The FDA has recently taken aim at several companies it says are marketing devices for uses other than those they were approved to treat. At issue is the use of energy and laser devices – usually used in dermatological and other similar procedures – for a treatment that has become known as “vaginal rejuvenation.” The procedure has been said to be capable of remedying several symptoms like vaginal dryness, pain during sex, and other types of discomfort. Some sales pitches also lay claim to tightening effects or even changing the patient’s vaginal appearance to something more “youthful.”

In leveling its accusations on the manufacturers, the agency has also attacked the procedures themselves and made frequent reference to reports it has received of burning, scarring, and other sources of pain that patients have suffered as a result of the treatments. Some doctors, however, are saying that the FDA needs to take a step back, and while it has the right to enforce marketing issues with the device makers themselves, any judgements over the medical viability of these procedures should be left to the medical community.

“The message to the consumer is very confusing because it really lumps it all together,” says Dr. Lauren Striecher. Dr. Striecher is a clinical professor of obstetrics and gynecology. She goes on to say that it “was really disheartening and, quite frankly, I think irresponsible of the FDA to make that statement when we do have a very solid medical literature that shows otherwise.”

That literature is bound to increase in volume as there are several ongoing studies into these types of procedures. Do not, however, make the mistake of calling them ‘vaginal rejuvenation.’ “Vaginal rejuvenation is not a medical term,” says Striecher, “and no credible doctor would use it.”

Risks, of course, go hand in hand with the possible benefits of such a procedure and Dr. Striecher notes that other sources for the discomfort or other symptoms should be ruled out before undergoing treatment. She spoke of one patient who visited her dermatologist and, after explaining her complaints, underwent a vaginal laser treatment. The problems persisted after the treatment, however, and only then did the woman visit her gynecologist. That was when she was properly diagnosed with ovarian cancer.

Technology continues to evolve at an alarming rate and it is up to all of us – regulators, doctors, and consumers alike – to find the most effective and safest uses of these technologies that also lead to the greatest benefits. At the same time, knee-jerk reactions and public statements by federal regulators can stifle this growth if the medical community is not allowed to do its job. As Dr. Eric Sokol, an associate professor of obstetrics and gynecology at Stanford says, “there are two sides of every story, and we have to find the middle-ground, allowing new technologies to emerge.”