The article anecdotally describes the wondrous benefits of a fractional carbon dioxide laser marketed as MonaLisa Touch designed to decrease vaginal dryness and tissue shrinkage in women given certain drugs for the treatment of breast cancer, and presumably other women who are perimenopausal. For whatever reason, FoxNews chose to profile one MD and his series of 15 patients. Few details are given about the clinical research upon which the device’s many claims are based. Because the procedure is very new (it was introduced in the United States in December 2014), nothing is known about long-term benefits or harms from the procedure. This is an example of a story that is digestible without being very useful.
Women’s sexual health issues are under-studied and under-treated. Some post-menopausal women develop vaginal dryness, painful intercourse and other symptoms as a result of thinning of the vaginal wall when estrogen levels decrease. The same holds true for some women who take anti-estrogen medications like tamoxifen following breast cancer. These women could potentially benefit from new therapies that increase lubrication and comfort when the standard therapies like estrogen replacement therapy or vaginal lubricants are impractical or fail to deliver a cure.
The article states the procedure can cost up to $3,000. The initial treatment covers three therapy sessions with a followup treatment to be completed each year. The article clearly states that the procedure is not covered by insurance.
The article describes an 85 to 90 percent improvement following the therapy (increased lubrication, less pain) and quotes the trial investigator claiming that 13 of 15 patients “were basically cured.” But the story seems to infer that this one physician’s experience with 15 patients constituted a scientifically valid experience, at least to some extent. And it doesn’t. We learn nothing about the patient population he treated.
The story could have at least quoted the outcomes that are in the (very limited) literature.
Testimonials and anecdotes don’t equal reliable data. The article makes an effort to list the potential harms (spotting, slight pain) but omitted the potential for infection. Since the laser probe sometimes causes spotting following a treatment there is a chance of infection. The article does note that the insertion of the laser may hurt a little bit, similar to a pap smear procedure.
The claims for the device are based on preliminary research but the article doesn’t state that. It kind of makes up for that weakness by stating that there hasn’t been a comparative effectiveness trial or a placebo controlled trial. (We did find an abstract in PubMed from an Italian investigator’s pilot study.) A news release states the trial results were presented at a symposium chaired by Mickey Karram, MD, director of urogynecology at The Christ Hospital in Cincinnati, Ohio, the primary source quoted in the article.
The story stated that, “Despite dire conditions, only 20 to 25 percent of postmenopausal women seek treatment.”
First, the symptoms and the condition may vary considerably among individuals, and so can how much they affect different individuals’ lives. They’re not all dire. The statistic about 20-25% seeking treatment seems meaningless without source or context.
There is a lot of potential conflict-of-interest that could have been pointed out in this story. The clinic that employs the primary source, Dr. Karram, as a director, imported the technology from Italy where it was developed. The clinic where he serves as a director is promoting the device through websites. Dr. Karram is a frequent presenter at symposiums sponsored by Cynosure, the device manufacturer. A truly independent voice would have lent this story more credibility.
Estrogen replacement therapy (ERT) and vaginal moisturizers and lubricants are described as current therapies for vaginal dryness. The laser is presented as an alternative therapy for whom ERT is not advised and for whom moisturizers don’t work.
We know that the treatment is available in some locations since the article quotes a patient who underwent the procedure. The article also provides the website address for more information. The story also notes that a qualified gyn should deliver the treatment. When one of our reviewers checked out the “find a doctor” app on the device’s website, it listed several apparently free standing clinics and practices in Maryland, where she lives.
There’s another laser treatment on the market called Femilift that appears to address the same symptoms using similar technology. So to report on this one laser approach in isolation without reporting on competitors is shallow, and a bit like advertising.
The story feels promotional, but, frankly, we have no evidence that the story relied solely or largely on a news release.