Botox for Vaginismus: Safety

Safety experience with Botox for vaginismus

From 2005 to September 2013 we have treated over 245 patients with Botox for vaginismus. Our experience of using Botox for vaginismus shows that Botox has a high degree of safety. Two complications of minor stress incontinence have been noted, both of these cleared after about four months when the Botox was no longer active. There have been no complications using Botox for migraine headaches or for excessive sweating. One minor complication occurred in the cosmetic use which cleared at about four months. It is for these reasons I am comfortable speaking about the safety of the drug.

Botox for vaginismus

Most people are familiar with Botox and many think of Botox as being used for cosmetic reasons. Botox has received a great deal of press. There are some 150-200 indications for the use of Botox. I have used Botox for cosmetic reasons, migraine headaches and excessive sweating in addition to a busy practice treating vaginismus patients. As a result I have experience with thousands of injections. Botox is considered to be one of the safest drugs when used by doctors who are experienced with this drug and when only the FDA approved product made by Allergan is used.

Why is Botox safe?

Botulinum toxin A is attenuated which means there is a high degree of dilution so that it can be effective yet not cause illness. It is similar to the concept of vaccines though theprocess of dilution is different. We give our kids polio vaccines, yet they do not develop polio. The principal of using highly diluted drugs for therapy is well known through the health care industry.

There is an enormous volume of literature on the use of Botox. Whenever a new drug is used, or a new application of an existing drug is used, one needs to receive IRB approval (Institutional Review Board approval) as well as FDA approval which often includes the need for an IND approval (Investigational new drug approval). I received all of these approvals as I developed the Botox program for vaginismus. As a requirement of these approvals, I need to monitor the patients and record any complications. The minor complications are noted above, and these were all temporary. We have never had a permanent side effect.

FDA approval for Botox for vaginismus

We are the only FDA approved program in the United States that allows for the continued research using Botox for vaginismus. All patients are monitored both short term and long term for continued data analysis.


The use of FDA approved Botox by trained physicians has a high degree of safety. Using Botox as part of a comprehensive treatment program for vaginismus is effective and has a high margin of safety.

If you have any questions about our Botox treatment for vaginismus and progressive dilation under anesthesia, please contact us via our contact us form.

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About Dr. Pacik

Peter Pacik, MD, FACS is a recognized pioneer in treating patients with Botox for vaginismus and the author of When Sex Seems Impossible: Stories of Vaginismus and How You Can Achieve Intimacy. He has been in practice for over thirty years and belongs to a small group of prestigious surgeons who are double board certified by both the American Board of Surgery and the American Board of Plastic Surgery. In 2010, Dr. Pacik received FDA approval to continue his study to treat vaginismus using intravaginal injections of Botox together with progressive dilation under anesthesia.
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