The Long-Term Effects of Facial Implants: Preliminary Study
ALVIN I. GLASGOLD, M.D.,* AND FREDERICK H. SILVER, PH.D.*
The objective was to study the long-term safety and benefits of facial implants. This was a retrospective study of patients undergoing facial implant surgery over a 10- year period. All surgery was performed by the senior author in a hospital or ambulatory facility. Four hundred and eighty-four questionnaires were sent to patients of the senior author who underwent molar or mandibular augmentation with preformed silicone implants during the years 1982 to 1992. Two hundred and seven replies were received. Patient satisfaction rate of 99% was recorded. No serious complications occurred. There were no instances of connective tissue or other related systemic disease in any of our patients following facial implant surgery.
Silastic implants in the malar and mandibular areas are safe procedures with a roil' high rate of patient satisfaction and a very low complication rate. Based on our study and those of others, there does not seem to be a relationship between silicone implants and the development of connective tissue disease.
There has been a great deal of interest and concern regarding the use of alloplastic implants. The Food and Drug Administration (FDA) position on breast implants has brought this to the attention of the public. The FDA is taking a greater interest in the safety of medical devices and the idea that certain standards should he established to protect the patient. Constantino et al., in their review of synthetic biomaterials, pointed out the excellent biocompatibility of silicone implants particularly when particle size is larger than 60 µm.' The track record for silicone rubber implants during the past three decades has been excellent. This is substantiated in a survey of complications of augmentation mentoplasty. In more than 11 000 cases with various implant materials, silicone had the lowest complication rate, 2.7% for solid silicone and 2.6% for silicone gel. The complications were all local, and there is no mention of associated systemic disease.' A major concern in discussing the safety of implants
Received for publication January 20. 1995.
* UMDNJ-Robert Wood Johnson Medical School,
Piscataway, New Jersey.
next page>> |
