Standing the Heat in Implant Dispute

The details of the Food and Drug Administration’s final decision Thursday to limit the availability of silicone breast implants are no surprise. What’s surprising--and commendable--is that FDA Commissioner David A. Kessler held firm in the face of tremendous pressure from physicians and medical device manufacturers. Although many details must still be worked out, Kessler’s ruling, following the recommendation of his advisory panel, appears sound and compassionate. Silicone implants will now be available only under long-term, controlled clinical studies, and the number of women who can receive implants solely for breast augmentation will be limited.

However, women who have begun the multi-step process of reconstructive surgery, to correct severe deformities or after a mastectomy, may conclude that process without further delay. Kessler indicated that women who become candidates for reconstruction can also obtain implants.

Kessler said that his decision “is not . . . ‘business as usual.’ Our primary goal is to put in place a process to obtain adequate information about the safety of these devices.” That is wise, as questions remain about long-term silicone implant safety, despite a public relations blitz in recent months by some in the medical community designed to reassure women and blast the FDA as meddlesome and needlessly raising fears. Kessler’s action will cause hardship for some women, physicians and implant makers, but it is in everyone’s best long-term interests.