Breast implant ban rejected FDA panel advises rapid safety review

November 15, 1991|By Gregory Spears | Gregory Spears,Knight-Ridder News Service

GAITHERSBURG -- A Food and Drug Administration advisory panel voted unanimously yesterday to recommend keeping silicone gel breast implants on the market despite concluding that the devices have not been proved safe.

The panelists said additional information on the popular implants used in elective cosmetic breast surgery should be gathered as rapidly as possible to answer lingering questions about their safety.

Witnesses testified that the implants could cause severe allergic reactions in a few women and that tests linking the devices to other illnesses, including lung cancer, were inconclusive.

The panel's surprise recommendation to the FDA was welcomed by the American Cancer Society and many breast cancer patients who argued that the option of reconstruction would encourage women to seek early detection for breast cancer.

Panel members said that while the devices could not be proved safe using current evidence, questions about their safety could be answered within two or three years. In the meantime, several panel members said, there is no acceptable substitute for the silicone-filled implants.

Throughout three days of intense public debate, many women -- including the seven women on the panel -- said the government shouldnot restrict their right to make life-changing medical decisions in the absence of proof of harm.

The panel's final 10-0 recommendation to keep the devices on the market appeared to fly in the face of its overwhelming votes Wednesday and yesterday that each of the four manufacturers had failed to prove the devices safe. However, the panelists said the overriding public health benefit of keeping implants availableoutweighed the risks they might pose to some women.

The manufacturers are Dow Corning Wright of Midland, Mich., the originator of the silicone gel; Mentor Corp. of Goleta, Calif.; McGhan Medical Corp. of Santa Barbara, Calif.; and Bioplasty Inc. of Minneapolis.

"The decisions that we made are not that these devices are unsafe but that there is insufficient scientific information to decide if these devices are safe," said Myron Spector, director of the orthopedic research laboratory at Brigham and Women's Hospital of Boston and a member of the panel. He said that when additional data were gathered, "it is likely that the decision will be made that these devices are safe within reason."

The FDA has until Jan. 6 to decide what action to take. Its options include removing the devices from the market or permitting them while further testing is done.

"The FDA has reached no decision," FDA Commissioner David A. Kessler said after the panel adjourned. "Regardless of the decision on continued availability, the FDA will make sure that the [additional health] data is collected and collected expeditiously. Women deserve that."

Officials of the companies strongly defended the safety of their products throughout the three days of hearings, the first held by the government since breast implants were introduced 30 years ago.

Robert R. LeVier, technical director of Dow Corning's health care businesses, pledged to cooperate fully with the FDA in providing additional safety data.

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