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.     

Quantitatively distinct requirements for signaling-competent cell spreading on engineered versus natural adhesion ligands.

To design synthetic microenvironments that elicit desired cell behaviors, we must better understand the molecular mechanisms by which cells interact with candidate biomaterials. Using cell lines with distinct alpha5beta1 integrin expression profiles, we demonstrate that this integrin mediates cell spreading on substrata coated with genetically engineered artificial extracellular matrix (aECM) proteins containing the RGD sequence (RGD-containing aECM protein [aRGD]) but lacking the PHSRN synergy site. Furthermore, aRGD-mediated adhesion stimulates an intracellular focal adhesion kinase (FAK) signal that is indicative of integrin tethering. Although both aRGD and the natural ECM protein fibronectin (FN) support alpha5beta1 integrin-mediated cell spreading, quantitative single-cell analysis revealed that aRGD-mediated spreading requires ten-fold greater threshold amount of integrin expression than FN-mediated spreading. Our analysis demonstrates that aRGD-based substrata mediate both biophysical (cell spreading) and biochemical (FAK signaling) events via the alpha5beta1 integrin, albeit with efficacy quantitatively distinct from that of natural ECM proteins that possess the full spectrum of adhesion and synergy domains.     

Histological changes over time around the site of sustained release naltrexone-poly(DL-lactide) implants in humans.

In order to assess the histological tissue changes over time around the site of implant, tissue biopsies were taken at 1 to 38 months post-implant from 54 (34 male) consenting human subjects who had received the Australian subcutaneous naltrexone-poly(DL-lactide) implant for heroin dependence. The implant consists of multiple tablets containing compressed naltrexone-poly[trans-3,6-dimethyl-1,4-dioxane-2,5-dione] (DL-lactide) loaded microspheres. Assessment of tissue samples by pathologists showed an early phase (up to 12 months post-implant) of inflammation, foreign body reaction, and fibrosis. This subsided gradually over the next 12 months until tissue returned to normal by 25+ months. Sufficient evidence was not available to conclude that the poly(DL-lactide) implant matrix was totally biodegradable within the study period. While implant material was not identified in most of the latter biopsies, its presence was noted in one biopsy at 26 months post-implant. Nevertheless the study results did demonstrate the implant's biocompatibility by the lack of inflammation, foreign body reaction, and fibrosis detected by 25+ months. It seems highly probable that surgical technique rather than the implant itself was associated with the additional finding of fat necrosis. Moderate fat necrosis was observed as a common feature of biopsies carried out during the first 6 months following implant. It subsided to mild levels over the next 18 months, and was notably absent by 25+ months. The results of the study indicated that the Australian naltrexone-poly(DL-lactide) implant is well tolerated and may have a role for use in the management of medical conditions such as heroin dependence.     

A metropolitan experience with infrainguinal revascularization. Operative risk and late results in northeastern Ohio

Despite being of fundamental importance, the late results of major arterial reconstruction rarely have been documented throughout a large metropolitan area. In this study of 932 patients entered into the computer registry of the Cleveland Vascular Society, 19 surgeons representing 13 community hospitals and referral centers in Cleveland and Akron report the intermediate-term outcome during a mean interval of 35 months after infrainguinal lower extremity revascularization performed in northeastern Ohio from 1978 through 1982. Operative risk (5%), the early amputation rate (7%), and actuarial 5-year survival (48% to 55%) for patients with rest pain or tissue necrosis were significantly worse (p less than 0.05) than comparable figures (0.6%, 0%, and 77%, respectively) for others who underwent procedures for disabling claudication. Although both materials had similar success above the knee, the cumulative 3-year patency rate of autogenous vein bypass to the distal popliteal (69% to 88%; p less than 0.05) and tibioperoneal arteries (43%; 0.05 less than p less than 0.1) was superior to the results of polytetrafluoroethylene grafts (32% to 50% and 19%, respectively). Moreover, polytetrafluoroethylene grafts required reoperations at three times the rate of vein grafts to maintain limb salvage.     

Contribution of autologous blood transfusion in cardiac surgery in the adult

The use of autologous blood transfusion in cardiac surgery is still controversial. This study was prospectively designed to evaluate the haemodynamic and haematological benefits of this method, with special attention to its impact on reducing bank blood requirements. Between November 1983 and October 1984, 160 patients underwent cardiac surgery with extracorporeal circulation and were randomly assigned to two groups: group I (81 patients) was the control group and group II (79 patients) received autologous transfusion following extracorporeal circulation. Blood was withdrawn immediately after the induction of anaesthesia via a jugular catheter and stored in CPD solution at room temperature. The volume of blood removed was replaced with gelatin solutions; after bypass, blood was returned to the patient. There was no difference in systolic, diastolic or mean blood pressures between the two groups. Right atrial pressure and heart rate were not statistically different in both groups. Myocardial perfusion and myocardial oxygen consumption remained unchanged in group II compared with group I. Complete haematological evaluation was carried out before and during bypass, and thereafter daily for the first twelve days of the postoperative period. There was no significative difference between the two groups in platelet counts, fibrinogen levels, prothrombin and partial thromboplastin times. During extracorporeal circulation, mean haematocrit was 22.9 +/- 0.4% in group II and 25.3 +/- 0.5% in group I (p less than 10(-3)). The mean haematocrit time course was similar in both groups during the postoperative period and returned to preoperative value at discharge.(ABSTRACT TRUNCATED AT 250 WORDS)     

Results of resuscitation in injured elderly patients

This study assessed the results of intensive care in elderly trauma patients and quantified the different factors involved in the final outcome. It included 116 patients, aged 65 years or more, and covered a two year period. The following parameters were obtained for each patient: age, severity of trauma (ISS and SAPS), head injury (GCS), prehospital health status (ESA), survival after three months and quality of survival. Three months after trauma, overall mortality was 45.7%. Survivors were 72.8 +/- 4.9 year old, while those that died were 75.3 +/- 7.5 year old (p = 0.01). Mean ISS was 19.7 +/- 8 and mean SAPS was 9.4 +/- 3.2. The risk of death was 3.6 (1.6 to 8.1) times greater if ISS was over 15. The same risk was 4.7 (2.1 to 11.1) times greater if SAPS was over 9. GCS was 8.8 +/- 4.4 in dead patients and 12.5 +/- 2.4 in survivors (p = 0.001). The risk of death was 10.4 (4.2 to 26.2) times greater if GCS was under 8. The final prognosis could be assessed with the following exponential model: Survival = 1/(1 + exp - (8.7 - 0.07 X age - 0.07 X ISS - 2.9 X GCS*), where GCS is equal to 0 if the real GCS was under 8, and equal to 1 otherwise. The ESA did not affect mortality. Three months after trauma, the degree of independence was the same as before in 87% of survivors. It was concluded that age and the severity of trauma were the most important factors in determining prognosis in geriatric trauma patients.(ABSTRACT TRUNCATED AT 250 WORDS)     

Electron beam therapy for eyelid carcinomas

Forty-six (85%) basal cell and eight (15%) squamous cell carcinomas of the eyelids were treated with electron beams between 1963 and 1983. Lesion sizes ranged from microscopic to 4 cm, with 28 lesions larger than 1 cm. Thirty-eight lesions were treated with radiotherapy after incisional biopsy, and 16 were treated after excisional biopsy (specimens showed positive margins). Doses varied from 45 to 72 Gy, with daily fractions ranging from 2.12 to 4.0 Gy. There were six disease recurrences (10.9%): three in the treatment field and three at the treatment margin. Four of six recurrences were subsequently controlled by limited surgical excision and repair with preservation of the eye, whereas the other two required enucleation. Treatment sequelae such as skin atrophy, telangiectasis, and cosmetic results were evaluated in terms of radiotherapy parameters, pretreatment surgery, and size of the lesion. In 44 patients, the overall cosmetic result was judged as good to excellent, five patients had a mild to modest degree of deformity, and five had significant deformity. Such deformity was usually associated with tumor destruction or previous surgery. No major complications were noted.