Silicone: a critical review.
The response of biologic systems to implanted foreign materials is subject to a lesion of variables. Each type of implant must be individually evaluated in a specific application and host. Pure DMPS polymer injected into subcutaneous tissues behaves in a specific and characteristic way. An analysis of the behavior of other types of implants in other applications will not necessarily reveal insights applicable to the behavior of liquid silicone. Most adverse case reports relate to injected fluids of unknown purity or identity used in inappropriate volumes in poorly chosen anatomical sites. It is ironic that pure DMPS in small volumes, a theoretically ideal combination, is so mistrusted. However, liquid silicone's sinful potential was easy to predict. It was cheap, available, easy to use, and, when injected in large volumes, produced instant and financially profitable results. Moreover, a welter of confusing titles, "authorized investigators" and "medical grade silicone" coupled with sensationally adverse reports detailing a criminal misuse of this modality led to draconian measures banning its use and made a meaningful analysis of true incidence and type of side effects following its use nearly impossible to assess. The advocates' position that liquid silicone is safe when used properly cannot be refuted. Only a handful of serious adverse reactions can be documented following its use; however, the concept that pure DMPS polymer can, even in expert hands, occasionally produce immunologically mediated adverse effects is equally irrefutable. This concept is supported by the following evidence: 1. Minor idiosyncratic and granulomatous reactions occurring in 1 in 10,000 are reported in association with a nidus of infection or as a consequence of allergic events. 2. At least one serious inflammatory reaction occurred in a patient afflicted with both autoimmune disease and concurrent infection. These reactions are best understood in the broader context of tissue responses to all classes of implanted foreign material, and they are most easily understood in the narrow context of autoimmune disease after injection of implantable paraffin, silicone, and possibly "silicone polymers." "Certain authors speculate that silicone acting as a primary antigen is not likely," however, silicone acting as an adjuvant associated with a subclinical infection as an antigen source may be the cause of adjuvant disease. A careful review of published anecdotal and personal experience involving the use of 350 centistoke pure dimethypolysiloxane fluid (liquid silicone) for soft-tissue augmentation in small volumes (and in large volumes for facial hemiatrophy) suggests that the bias against its proper use is unfounded.(ABSTRACT TRUNCATED AT 400 WORDS)
Duffy
D M
DM
University of California, Los Angeles.
D062109:Dermatologic Surgical Procedures; D006801:Humans; D008845:Microinjections / Q000009:adverse effects / Q000379:methods; D019736:Prostheses and Implants / Q000009:adverse effects; D012828:Silicones / Q000008:administration & dosage / Q000009:adverse effects; D014481:United States; D014486:United States Food and Drug Administration
D012828:Silicones