Botulinum toxin and medical liability: is the patient sufficiently informed?]

INTRODUCTION: The use of botulinum toxin injection therapy is soaring significantly today, with an ever-wider field of applications despite well-known side effects of the treatment. This article aims at analysing the medicolegal practices of practitioners who use this therapy, especially the information given to patients and finding a common practice for providing that information. METHODS: We sent a questionnaire to 340 practitioners who might use the therapy (physiatrists, neurologists, ophthalmologists, ENT specialists, plastic surgeons) working in hospitals and in physical therapy and rehabilitation centres in France. Besides mentioning the possible side effects of the therapy, the questionnaire focused on how such information was transmitted before the injection. RESULTS: Data collection and analysis were performed by use of a spreadsheet software programme. A total of 124 questionnaires were analysed. We did not analyse the items dealing with side effects. Sixty-five percent of the responders said they did not seek statutory authorisation for injections. Only 31% provided written, detailed information and 12% required a signed consent form. Complaints were rare, approximately 12%, were written or verbal, and were always dismissed. DISCUSSION: Side effects after botulinum toxin injection are clearly described in the medical literature. Therefore, it is of utmost importance for this product to be used therapeutically and only by experienced therapists who will carefully respect the product's standard rules of use and inform their patients to the best of their ability. Issuing a detailed letter of information describing all the side effects seems necessary. We suggest a model information letter such as that provided to the patients in our facility. CONCLUSION: Botulinum toxin is a very worthwhile product for numerous abnormalities but has side effects, often brief, at the site of the injection. Therefore it is our duty to inform patients effectively.