A response to the FDA regarding the safety and effectiveness of vaginal laser and radiofrequency procedures

It’s all about patient safety? Or is it?

The CO2 laser has been FDA approved for many years to treat precancerous cells in the vagina and genital warts, treatments delivering far more energy to the vaginal tissues than used with Mona Lisa Touch Laser or Votiva radiofrequency. Those treatments “ablate” entire areas of the vagina and vulva to destroy tissue. The Mona Lisa Touch laser makes incisions scattered throughout the vagina and vulva that are superficial and generally cannot be seen within minutes to hours after treatment. I know this as I have performed almost 300 of these procedures without any complications.

Consumers are not given the whole story however.

Last month the FDA issued a safety alert stating these procedures cause burns, scarring and chronic pain. There were 14 reports of complications from over 100,000 procedures, or less than a 0.014 % complication rate. The statement claims “these procedures” are being done without adequate evidence to support their use.

Currently, there are multiple devices on the market, some much less expensive than others, performed in many settings, including spas to physician practices, fewer in OB/Gyn offices. Some procedures are performed by nonmedical personnel, nurse practitioners or physician assistants, other physician specialists and some by OB/Gyns. Clearly, generalizing the outcomes from all these varied options would not be an accurate assessment of the risks and benefits of a procedure. Women should be evaluated for appropriateness for treatment and have a recent pelvic exam, Pap smear if indicated, and possibly tests for infection prior to the procedure. Atrophy, the condition the Mona Lisa Touch Laser treats, predisposes patients to infection, which can make it seem like the laser treatment is causing burning and pain and instead it is an undiagnosed infection. This evaluation should be done by someone who specializes in Women’s Health and better yet, treating vaginal discomfort, atrophy and incontinence.

Since the safety alert, gynecologists from Northwestern University and the Harvard Women’s Health Watch have responded in support of these procedures stating the FDA has shown an “overabundance of caution limiting the availability of innovative therapies that when used correctly benefit women. It is irresponsible to scare women away from them.” There is solid medical literature supporting the use of these procedures including two studies, one in 2014 and more recently at Stanford in 2017, both with favorable results. Scaring women away from these procedures will make it harder to get women to participate in ongoing research studies.

Where would we be without new ideas and technologies in health care? Adopting laser and radiofrequency technologies to a growing need for treatment for vaginal discomforts is no different than the development of other procedures or medications, for example Viagra, which was originally developed to treat high blood pressure. Viagra can have serious side effects such as symptoms of heart attack, loss of vision and seizures, to list a few, yet where is the FDA’s safety alert here?

Another criticism is that vaginal laser and radiofrequency procedures keep patients from accessing appropriate alternatives such as hormonal therapies. Many patients are seeking out these procedures because they cannot or do not want to use hormones, or have not had improvement in their symptoms of dryness or discomfort with intercourse or urination with hormones or lubricants alone. Many women have resigned themselves to no longer having intimacy and continued infections. The package insert for estrogen cream lists heart disease, stroke and cancer as possible increased risks of use and yet these products are FDA approved?

The question arises that pharmaceutical companies may have exerted their influence on the FDA to release this safety alert due to decreased sales of hormonal products?

Lastly, there is concern that these procedures increase women’s’ insecurities regarding their appearance. Gynecologists, who specialize in sexuality and menopause, understand that how women feel about their appearance is one of the many elements that affect a woman’s sexuality and these insecurities shouldn’t be summarily dismissed but treated sensitively with reassurance, education and multiple treatment options.

In summary, women can be appropriately consented for these procedures and therefore deserve to have options allowing them to have comfortable, pleasurable intimacy and decreased infections. They should be performed by providers who understand their needs and specialize in these gynecologic procedures.

Kim Lane M.D.

Testimonial from a recent patient

We are excited to share another wonderful patient experience with the Mona Lisa Touch Laser and the treatment of Lichen Sclerosis!

“I would like to share my experience with the Mona Lisa Laser; I am 66 years old & married.”

Back in 2008 I found out I have Lichen Sclerosis which is an auto immune disease on the private area.

It causes thinning of the skin, among other things & is VERY uncomfortable to deal with & most often will not let you have any relations due to tearing of the skin. I was at the point where I had trouble sitting in a chair or having clothing touching me.

Dr. Lane was able to manage this condition for a few years. Then it got a whole lot worse and unmanageable. She suggested I try the Mona Lisa Laser treatment to regenerate healthy tissue growth and thus help clear the very uncomfortable condition I have. I had my 1st treatment in the early part of 2017; it consists of 3 treatments about 6 weeks apart in total. My 1st treatment I will admit was uncomfortable, but only due to the fact that I was so raw from the Lichen condition. It feels like a tiny pin prick and takes only a few minutes to complete the procedure. She used a topical gel to numb the area so you really don’t feel much pain. I would describe it more as a discomfort than pain. I was able to continue running my errands right after the treatment. The next 2 treatments were not nearly so uncomfortable. I was totally amazed at the difference of before and after. Like night and day. The healing process does not take long and I was able to resume relations with my husband. I would highly recommend this procedure to anyone with this condition.

Now spring forward 1 year, I am having some minimal issues with the Lichen again and went to see Dr. Lane. She suggested a booster, which is 1 treatment to keep this condition better under control. This treatment was not uncomfortable in the least. Understand this is not a cure for the Lichen, but it makes it 100% tolerable. My life before the Mona Lisa was looking a little bleak, but now I know this condition I have will not take over my life.

So again I highly recommend this to anyone with my condition, but there are other things it helps too.

So don’t be afraid to try the Mona Lisa Laser treatment.

-P.R.

Women’s Health Wise is in its 16th year!

The practice has grown and evolved, yet where has the time gone? I retired from deliveries but still enjoy seeing patients in the first trimester and getting them off to a good start.

I often say that empathy is a great teacher, and I find particular success in treating menopause! I am also very excited to report the amazing results we are achieving with the Mona Lisa Laser for vaginal dryness and discomfort in menopause and other skin conditions, such as Lichen Sclerosus. Experience does matter and I have performed well over 220 MLTLs. Patients report “This is an amazing procedure, truly life changing!” giving it an 8-10 improvement, even one 10/10!  I believe our success comes from addressing symptoms with multiple interventions, giving the best and most long lasting results.

I also enjoy being able to mentor students who go on to become OB/GYNs, nurses and Physician Assistants. My current MA is # 7, and off to P.A.school next fall.

Most importantly, I am grateful to be able to continue to practice independently. It certainly has its challenges and drawbacks, but every day I am reminded why I do what I do- for my patients, my employees, my friends and family.

New Treatment For Vaginal Dryness and Discomfort

At Women’s Health Wise, we are excited to announce the addition of the MonaLisa Touch Laser to our Longmont OB/GYN office! 

Monalisa Touch LaserThe MonaLisa Touch Laser is used to treat vaginal dryness, painful intercourse and the discomfort associated with menopause. This treatment uses a CO2 laser to stimulate collagen, elastin, and neovascularization which recreates the thicker tissue seen before menopause.

Conditions Treated by the MonaLisa Touch Laser:

  • Dryness
  • Pain
  • Itching
  • Painful Urination
  • Painful Intercourse

Patients experience significant improvement in these areas.

What is the MonaLisa Touch Treatment

laser treatment for vaginal atrophyThe treatment consists of 3 procedures that are performed in the office without anesthesia, each one taking only 5 – 10 minutes. The laser wand delivers energy pulses that are virtually painless. There are minimal side effects and no downtime. The procedures are 6 weeks apart and each one builds on the previous, stimulating even greater improvement. There have been no reported complications.

Who are Candidates for the Mona Lisa Touch Laser

Any woman experiencing vaginal dryness, discomfort, repeated vaginal or urinary infections, or discomfort during intercourse is generally a great candidate with few exceptions.

It can also be used to treat chronic vulvar conditions such as lichen sclerosis.

There have been over 20,000 procedures done worldwide and there is ongoing research for new indications which may include urinary urgency and incontinence. It has been studied in breast cancer patients who had overwhelmingly positive results and significant improvement in quality of life!

Testimonials

Learn More about this innovative treatment!

Having Your Tubes Removed May Decrease Your Risk of Ovarian Cancer

There has been evidence for some time that having had a tubal ligation (tubes tied) can decrease your risk of ovarian cancer. The reasoning behind this is that the pathway from the vagina to the ovaries is interrupted and therefore possible cancer causing agents can no longer reach the ovaries. In addition to this evidence, new research shows that actually removing the fallopian tubes may decrease your ovarian cancer risk by another mechanism. It may be that some ovarian cancers begin in the fallopian tubes.

These factors can increase your risk of getting ovarian cancer:

  • Age – The older you are, the higher the risk.
  • Family history – If someone in your family has had ovarian, breast or colorectal cancer the higher the risk.
  • Obesity – If you are overweight studies suggest you are at a higher risk for ovarian cancer.

These factors can decrease your risk of getting ovarian cancer:

  • Reproductive History – Women who have had children have a lower risk than those who have not had a child.
  • Birth Control – Women who have used birth control pills have a lower risk (up to 50%) of ovarian cancer.

These factors play a part in determining your overall risk for some types of ovarian cancer. This is important because, while it is not the most common form of gynecological cancer in women, ovarian cancer is the most deadly. Unfortunately, screening and early detection has limited value because in the majority of cases, the cancer is discovered only after it has spread to other parts of the body. It is important to note, up to 85% of women that develop ovarian cancer have no family history and no risk factors.

There is another factor that can reduce your chances of getting ovarian cancer. Having your fallopian tubes removed. Removing the fallopian tubes during hysterectomy may lower the risk of developing the most common type of ovarian cancer, researchers said in an article published in the American College of Obstetricians and Gynecologists journal.

What are Fallopian Tubes

Cervical Cancer Image of uterus ovaries and fallopian tubesThe fallopian tubes are structures connected to the uterus that lie open ended next to the ovary. During ovulation the egg is released from the ovary and  travels down the tube into the uterus. It can be fertilized anywhere along the way.

 

What is Ovarian Cancer?

Ovarian cancer is a cancerous growth arising from the ovary. Like most cancers, there are different types of ovarian cancer depending on where the cells begin to grow and what type of cells make up the cancer.

Symptoms of Ovarian Cancer

Unfortunately ovarian cancer does not have obvious or specific symptoms.

  • Abnormal vaginal bleeding or discharge.
  • Pain in the abdomen, pelvis, back or pain during sex
  • Abdominal pressure, fullness, swelling, bloating or clothes fitting tighter
  • Persistent upset stomach, gas, indigestion, heartburn or constipation
  • Loss of appetite or feeling full quickly
  • Feeling the need to urinate urgently or often
  • Fatigue

Removal of Fallopian Tubes

Removal of fallopian tubes can prevent ovarian cancerThe fallopian tubes are removed by transecting them from their connections to the uterus and the connective tissue that supports them. This does not effect the ovaries or the hormones that they produce.

 

At Women’s Health Wise we are encouraged by this research that offers a way to protect women from the deadliest type of gynecological cancer. We recommend that our patients discuss this procedure with our physicians to explore wether it is an appropriate option for them.