18-22 year-old women CAN legally and ethically have silicone implants!


Many medical products and pharmaceuticals are used "off-label." Botox is one I use frequently! Botox was originally FDA-approved ONLY for the treatment of glabellar frown lines (between the brows). Recently (2013), use in the "crow's feet" areas around the eyes was FDA-approved. But prior to that time, I would bet you that every one of my colleagues saying you can't have silicone implants until you are 22 injected countless of their patients with Botox for crow's feet! And forehead lines!

They did so legally and ethically, since they understood the use, the pharmacology, the risks and benefits, and detailed these in their informed consent discussions with their patients for whom they used Botox off-label. I do the same with women 18-22 who request, after proper informed consent, that I utilize silicone gel implants. I have them sign a special consent form outlining the FDA recommendation, but it is just that--a recommendation, NOT a restriction!

Additionally, I have never had an implant manufacturer refuse to sell me implants for patients who request off-label use, any more than Allergan would refuse to sell me Botox for use in crow's feet or forehead lines! They have always honored their warranties as well. No physician will "lose his or her license" for appropriate, informed consent use of silicone gel implants in a woman under the age of 22. Many products and pharmaceutical other than silicone gel implants and Botox are used off-label every day, by honest, ethical physicians who choose what they feel is best for their patients.

And manufacturers know multitudes of physicians use their products off-label; they simply cannot promote their products' off-label uses!

Off-label use is perfectly legal and ethical, assuming patients are given full informed consent, including the inanity of the FDA's recommendation, since this recommendation is NOT based in scientific reasoning.  (The FDA studies regarding silicone implants only included women 22 and older--hence, the recommendation.) You can drink alcohol, go to war, vote, and buy a gun legally at age 21--but you cannot get silicone implants? Does anyone sense my outrage at this non-scientific stupidity?

Malpractice carriers do not specify how their clients practice medicine, nor do they restrict patient choice to only those "recommended" by the FDA. Doctors who use silicone implants in women under the age of 22 are doing nothing illegal, unethical, and will not lose their licenses, malpractice coverage, or implant warranties!

These "arguments" are specious, but wrong. Seek out plastic surgeons who are not afraid to place the welfare of their patients before an inappropriate "recommendation." I support the right of fully-informed women age 18-22 to choose silicone gel implants, and will happily utilize them if they request that I do so!   Dr. Tholen
Article by
Minneapolis Plastic Surgeon