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This article was originally published in The Gray Sheet

Executive Summary

SALINE-FILLED BREAST IMPLANT PMA GUIDANCE on psychological and materials testing should be developed before FDA promulgates final rule calling for premarket approval applications for silicone inflatable breast prostheses (saline-filled breast prostheses), according to breast implant manufacturer Mentor. In April 7 comments on FDA's Jan. 8 proposed call for PMAs ("The Gray Sheet" Jan. 11, p. 2), the firm maintains that "FDA should refrain from promulgating the final 515(b) rule...until the agency clearly defines certain pre-clinical and clinical testing requirements in a guidance document." Because "no validated instrument deemed appropriate for evaluating the psychological benefit of mammary prostheses has been publicly recognized by the agency to date," Mentor recommends that FDA "provide detailed guidance that outlines a validated instrument for conducting such studies." The firm argues that it is "not appropriate" to "expect manufacturers to conduct further psychological testing in the absence of a valid testing method deemed acceptable by the agency." FDA should develop the guidance with "industry and the medical community" and should include in it "an appropriate time frame for collecting the specified data." Mentor calls for FDA to provide a materials testing guidance due to the difficulties expected to be associated with requalifying silicone raw materials replacing those being withdrawn from the market by Dow Corning. Mentor asserts that "such tests require considerable time and planning, as well as a great deal of guidance from the FDA in reaching agreement on the type of testing needed to demonstrate equivalency and acceptability of the materials." FDA is working with the Health Industry Manufacturers Association to develop tests that would be used as part of an expedited clearance process for replacement ("The Gray Sheet" April 12, p. 9). The guidance on psychological and materials testing should be provided in conjunction with a "reproposed 515(b) rule...with reasonable, appropriate time frames," Mentor says. FDA needs "to reevaluate" the proposal after reopening "dialogue with industry, the scientific and medical communities in order to develop a consensus on the exact scope and nature of some of the preclinical, material and clinical data requirements" in the proposed call for PMAs, according to the firm. Mentor contends that the 515(b) proposal as currently drafted will lead to "scrutiny as to the benefits of the device" that is "inconsistent with that applied to other devices." For example, the firm says that "FDA should clarify why it is requiring psychological data for silicone mammary to support approval, but did not require such data to establish the safety and effectiveness of other implants which also have cosmetic utility." In addition, FDA's requirement for data from prospective clinical studies is "inconsistent" with "the degree of risk" posed by saline-filled breast implants and with "the legislative history" of the 1976 medical law, according to Mentor. The firm notes that "data from available reports and literature" is "acceptable for various in vitro data requirements" in support of pre-amendment replacement heart valve PMAs. Mentor finds it incongruous that FDA is applying "a more rigorous standard" to saline-filled breast implants than to a heart valve, which is a life sustaining-device. "If retrospective data is acceptable for 'old' heart valve PMAs, then similar data should be acceptable for silicone inflatable breast implants as 'old' devices," the firm says. Mentor also believes that saline breast implant manufacturers should be given more time to prepare PMAs; the proposal would require that PMAs be submitted 90 days after the rule is finalized.

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