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This article was originally published in The Gray Sheet

Executive Summary

TESTICULAR PROSTHESIS EFFICACY MEASUREMENTS IN PMAs should include assessments of "the degree of maintenance or enhancement of a male's psychological well- being post-implantation; and the anatomical effect provided by the device in vivo," FDA says in a draft guidance on the preparation of testicular implant premarket approval applications that was released at an April 15 meeting of the agency's gastroenterology and urology devices panel. The agency says that psychological assessments, which can be made using "scientifically valid" questionnaires, are important because "the primary benefit of the testicular prosthesis is cosmetic in nature." The psychological assessments should include a statistical comparison of the pre- and post-surgical "psychological status" of patients. Pre-surgical assessments should include "measures of the perceived loss that these subjects experience and their expectations for improvement with the device," FDA says; post- surgical psychological assessments should be made for five years or until maturity of the patient, whichever occurs later. FDA also wants sponsors to compare psychological test scores of treated patients with those of a control group that did not receive the device. Researchers also should provide a "correlation of the psychological data with the physical outcomes of the implantation procedure," the guidance says. At the April 15 meeting, panel consultant Alan Bennett, MD, Albany Medical College, Albany, New York, questioned the draft guidance's recommendations for psychological assessments. He asserted that "pre-operative psychological testing in a seven-year- old who is getting a testicular implant for undescended testis is kind of silly," as is "a pre-operative assessment in a twenty-three- year-old who's having a radical orchiectomy." He maintained that "it may be very difficult to keep these products, which do help in many, many patients, on the market unless we modify in some significant way the protocols" suggested in the guidance. The agency's recommendations for performing anatomical assessments prompted little comment. The guidance proposes that implant recipients undergo post-surgical followup that includes evaluations of the implant's stiffness, position and dimensional characteristics. The evaluations should continue for five years or until maturity, whichever occurs later. "Patient assessments of the physical presence of the implant" also should be taken into consideration, FDA proposes. The suggested safety assessments in the draft guidance are similar to those outlined in a January proposed call for PMAs for testicular implants, which are pre-1976 Class III devices ("The Gray Sheet" Jan. 11, p. 5). The prospective studies should have "clear" objectives and should evaluate potential risks such as migration, rupture, leakage, fibrous capsular contracture, infection and patient dissatisfaction. Again, followup data should be collected for five years after the implantation or until the device recipient reaches physical maturity, whichever occurs later. Commenting on the safety requirements, Reginald Bruskewitz, MD, University of Wisconsin Medical School, Madison, said: "I think the study design is very nice but I don't know whether the study will ever get off the ground because the numbers [of implant patients] aren't there anymore." According to Bruskewitz, the decline in implantees is due to the fact that "patients who have been offered [a testicular implant] don't want it because they...don't know" the risks from a device that has similarities to breast prostheses. Panel Chairman John Wallin, MD, Louisiana State University School of Medicine, New Orleans, added: "Safety is the key...There's no question of efficacy. You put a mass in the scrotum, and it's there."

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