Thursday, July 17, 2014

Botox Isn't Just for the Face Any Longer

A trip to your physician these days may mean more than just a check up of your heart, lungs and blood pressure, especially if you're a woman. It may mean the answer to some women's most intimate problem and help with the resulting psychological stress that accompanies it. I am, of course, referring to Botox injections for the treatment of vaginismus, "a poorly understood condition affecting approximately 1-7% of females worldwide" and which inhibits sexual activity.

Since 2010, clinical trials have been investigating the use of this product and the results along with counseling and other interventions would seem to be beneficial for a number of women. Sexual dysfunction isn't something I specialize in and I wasn't aware that this acutely lethal toxin was now being used for disorders far afield from the usual crow's feet and brow wrinkles. 

What does this toxin do? For one thing, it paralyzes muscles so that they, in effect, relax. The formulation is a prescription medical preparation not intended to cause harm, but care and experience most certainly must be two of the main considerations here. This would be especially important when placing these injections around the  eye where a slip of the needle could have unexpected results. The result isn't permanent, either, and for cosmetic purposes the patient would need to be seen anywhere from four to six months for another set of injections.

Medical uses include certain neural disorders of the eyes, cerebral palsy, MS, excessive eye blinking and hyperhidrosis, or excessive sweating in the underarm area. An interesting aside here about Botox and crow's feet might be called for. Although physicians have been injecting faces with Botox for years to eliminate these lines around the eyes, the FDA didn't approve this use until 2013. It would seem a lot of off-label use has been going on and nobody was checking.

Today, I learned of yet another use of this product. While talking to a physician about a particular class of medications, he casually mentioned that a new group of dermatologists in the area were doing something like a land office business in Botox injections of the vagina. I had heard it was being used for bladder incontinence problems and migraine headaches, but I hadn't heard this use. Plus, the fact that these physicians were dermatologists not OB/GYNs came as a surprise. Isn't this out of their usual area of expertise?

The FDA has approved both the bladder and migraine usage but this one was something new to me.  A search of the FDA website turned up nothing on the status of this use although I did find on other websites that clinical trials were approved in 2010. Only one plastic surgeon was named as the clinical investigator for this sexual indication and it was an open-label, single center study for which there appears to be no current postings other than 2012 when the study ended. Therefore, it would appear that a definitive position on approval has not been reached at this point and it may still be an off-label indication.

Which other medical practitioners are using this product? Well, it's not always licensed professionals involved in its administration. On a trip down to Florida, I was, once again, surprised to hear that a friend had gone to a Botox party and had much of her face injected by an individual without a medical license in the U.S. but with one in Central America. You couldn't beat the fee ($350) because many dermatologists will charge as much as that for just doing your crow's feet and frown line between your eyes. But I shouldn't have been surprised at this, either, because just weeks before that trip I found myself in a dentist's office. Looking around, I picked up a leaflet on a table and voila, there it was. The dentist now has Botox parties, too, and one of his partners does the shooting.

Dentists in California have petitioned the licensing boards for permission to begin doing various forms of plastic surgery, so I guess we may see that spreading to the East Coast, too. I know that dentists have a terrific knowledge of head and neck anatomy, but how much actual plastic surgery experience could they have? I have to admit that I would be hesitant to even consider this type of procedure by anyone but a highly experienced facial plastic surgeon. In fact, looking at some of the women in fan magazines I see enough examples of plastic surgery run amok where I would have expected excellent results normally. No, I am not talking about Jocelyn Wildenstein. She did it on purpose to look like her cat, or so the story goes.

Pushing the envelope might be an apt term here when considering Botox. I have nothing against it. If it helps someone's quality of life in any way and is not an example of a serious personality disorder, it's fine with me. But who am I to even say I approve? No one needs my approval. 

The point here is that persons who are not medical professionals are gaining access to the product. There is now a flourishing underground business in this procedure and, once again, it's buyer beware time. But even medical professionals not trained in specific subspecialties are utilizing the product for off-label indications and I just wonder who's monitoring this and what the consequences for patients may be.  The money train, however, keeps right on rolling on.

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