Toxicology of polymers for implant contraceptives for women.
This article reviews the toxicology of polymers that are used in contraceptive implants. The two main classes of synthetic, nondegradable polymers used in the delivery of female contraceptives are silicone elastomers (e.g., Silastic) and ethylene co-vinyl acetate (EVA; ELVAX). The controversies surrounding the silicone breast implants have prompted several studies to evaluate the toxicity of silicones. The epidemiologic data obtained thus far have overwhelmingly concluded that no correlation exists between certain chronic symptoms, such as arthritis, in patients and silicone prosthesis. This conclusion has been echoed by the expert panel report by the Institutes of Medicine. Although the IOM report focused on the safety of silicone breast prosthesis, data emerging from the joint reconstruction area also suggests that Silastic is safe for in vivo use. The toxicological studies on EVA are few, and the conclusion thus far is that they elicit no adverse local or systemic response over extended periods in vivo. In conclusion, the prognosis for Silastic and ELVAX as of now is excellent. However, any future implant development using these polymers should place an emphasis on processing parameters to minimize potential small molecule leachants and establish safety as a function of both site and duration of implantation.
Shastri
Prasad Venkatram
PV
Department of Materials Science and Engineering and School of Medicine, University of Pennsylvania and Children's Hospital of Philadelphia, Abramson Research Center, Philadelphia, PA, USA. shastriv@seas.upenn.edu
D000818:Animals; D020099:Coated Materials, Biocompatible / Q000009:adverse effects / Q000633:toxicity*; D003271:Contraceptive Agents, Female / Q000009:adverse effects / Q000737:chemistry / Q000633:toxicity*; D004129:Dimethylpolysiloxanes / Q000009:adverse effects / Q000737:chemistry / Q000633:toxicity*; D004343:Drug Implants; D005260:Female; D006801:Humans; D011145:Polyvinyls / Q000009:adverse effects / Q000737:chemistry / Q000633:toxicity*; D012828:Silicones / Q000009:adverse effects / Q000737:chemistry / Q000633:toxicity*
D020099:Coated Materials, Biocompatible; D003271:Contraceptive Agents, Female; D004129:Dimethylpolysiloxanes; D004343:Drug Implants; D011145:Polyvinyls; D012828:Silicones; C016438:ethylenevinylacetate copolymer; C013830:baysilon