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This article was originally published in The Gray Sheet

Executive Summary

INFLATABLE PENILE IMPLANT HEALTH RISKS "OVERSTATED" in FDA's proposed call for safety and efficacy data on the devices, according to the American Urological Association. In a June 2 letter to the agency, AUA expresses concern that "some of the risks may be overstated, and the value of inflatable implants misunderstood." FDA outlined potential significant risks with the pre-1976 devices in an April 28 proposal calling for premarket approval applications ("The Gray Sheet" May 3, In Brief). Specifically, AUA asserts that "there is no evidence that immunological (autoimmune) diseases, malignancy, infertility or birth defects occur in men implanted with an inflatable prosthesis." In the proposal, the agency maintains that the "potential long-term adverse effects of penile inflatable implants, such as cancer, immune related connective tissue disorders, reproductive and teratogenic effects, and later effects in offspring, are unknown." FDA asks that data be submitted on the devices "regarding the chronic toxic effects including possible reproductive and teratogenic effects of silicone." In the call for PMAs, FDA says that clinical studies of penile implants should include measurement of "the psychological benefits of the device (to both the implant recipient and his partner)." Although AUA does not comment on the need to conduct additional psychological testing, the association asserts that existing studies "indicate that up to 80% of men who receive an inflatable penile prosthesis are pleased with the implant and have been able to resume sexual functioning. Benefits of the penile prosthesis include improvement of quality of life." AUA acknowledges, however, that "complications such as device failure, infection and extrusion of the prosthesis occur in up to 30% of patients over time, requiring additional surgery in some." AUA points out that inflatable penile implants have been used to treat erectile dysfunction since the early 1970s, and "for many men [are] the only effective treatment available for their impotence." The association concludes by recommending continued use "of inflatable penile prostheses in men with sexual dysfunction who are well informed about the potential complications of the implant procedure." Comments on the proposed rule currently are due by June 28. Pfizer subsidiary American Medical Systems, however, has asked that FDA extend the comment period to Oct. 28. The company manufactures four inflatable penile implants: the 700 CX, 700 Ultrex, 700 Ultrex Plus and Dynaflex. In a June 2 letter to FDA, the American College of Surgeons submitted comments on the agency's Jan. 13 proposed call for PMAs on testicular prostheses ("The Gray Sheet" Jan. 11, p. 5). The comments address risks cited by FDA in the proposed call for PMAs. For example, ACS opposes FDA's listing of human carcinogenicity as a significant risk associated with implantation of the devices, stating: "There is no evidence available...that testicular prostheses themselves are responsible for an increased level of human cancers." Fibrous capsular contracture, which was listed by FDA as a potential risk, "does not represent a health hazard, life- threatening risk or physical disability," ACS asserts. With regard to the risk of infection, the college says that there is "little evidence at present that testicular prostheses carry a risk of infection under normal precautionary circumstances any more than the placement of any foreign body within human tissues." In response to FDA's statement that "immunological sensitization may be a serious risk associated with" implantation, ACS notes that "scientific evidence to date does not demonstrate any cause and effect relationship between the testicular silicone implant and the subsequent development of autoimmune diseases." The college agrees with FDA, however, that "additional research needs to be completed." As a final comment on FDA's proposal, ACS points out the importance of recognizing the psychological benefit of the device. The group concludes that, although it is "difficult to document and quantify a psychological benefit," the "preponderance of evidence showing a psychological benefit should not be underestimated or undervalued."

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