Journal Criticizes FDA for Breast Implant Restrictions
In an unusual confrontation, the nation’s most influential medical journal and the Food and Drug Administration clashed today over restrictions on silicone gel breast implants.
The New England Journal of Medicine, in a strong editorial, suggested that the FDA’s decision to remove silicone breast implants from the market is troubling and misguided.
The FDA’s April 16 decision allows patients with a medical need to receive the implants as part of a safety study. In addition, some women desiring implants for cosmetic reasons will be included in these studies. The ruling “has given rise to great fears among the 1 million women now living with implants,” said the journal’s executive editor, Marcia Angell.
But in a separate essay, FDA Commissioner David A. Kessler defended his decision as part of the agency’s duty to protect citizens from potentially unsafe medical devices.
“If members of our society were empowered to make their own decisions about the entire range of products for which the FDA has responsibility, however, then the whole rationale for the agency would cease to exist,” he said.
Silicone breast implants have been available for 30 years. But Kessler said the agency was forced to act because the devices have never been subjected to government-monitored safety studies and because of numerous reports from women who say the implants have caused serious medical problems. Under the restrictions, primarily women in medical need, such as mastectomy patients, can receive the implants if they agree to enter a study that will seek to answer safety questions over the next few years.
But Angell said the option to have implants should be left to women “regardless of participation in studies and regardless of whether the purpose is augmentation or reconstruction” as long as all women receive detailed information about potential risks.
“Dr. Kessler has overreacted to what the likely risks are,” Angell said in an interview. “We’ve had a long enough time to have a feeling for what the risks are.
“In a sense, (the decision) is treating women like little girls.”
Further, Angell said, limiting the implants to mastectomy patients “has the effect of coercing women with breast cancer to become subjects of clinical studies.”
Mastectomy patients have other options for reconstruction, such as saline implants. But those implants are considered cosmetically inferior and have not been subjected to safety tests.
Critics of the FDA’s decision have also argued that the needs of women seeking silicone implants for breast augmentation have been ignored.
“A distinction is being made between the cancer patient and the patient having it done for augmentation, as if the cancer patient’s need is valid and the augmentation patient’s is not valid,” said Dr. Susan Love, a breast expert affiliated with the Faulkner Hospital in Boston who will join the staff of UCLA on July 1. “Who are we to judge? I would have been happier if they were opening (the study) up to everybody.”
While acknowledging the criticism, Kessler said the decision was a matter of law and common sense.
A 1976 federal law requires that medical devices be shown by their manufacturers to be safe and effective before they can be used. While implants were on the market before that time, Kessler said, “under the law, ‘grandfathered’ devices such as breast implants must eventually meet the same requirements as new devices: They must be shown to be safe.”
By allowing only women with a medical need to enter the study, the FDA has determined that the needs of the patient requiring breast reconstruction outweigh those who desire cosmetic surgery, he said.
Moreover, he said, women who want implants for augmentation are at higher risk for problems because the device might complicate the use of mammography for detection of breast cancer.
“These restrictions on the use of silicone gel implants for breast augmentation are not based on any judgment about values,” Kessler said.
But there is no proof of a delayed diagnosis of breast cancer among women who have had augmentation, San Diego surgeon Jack C. Fisher said in another editorial.
The FDA based its decision on “poorly documented assertions” about the risks, creating unnecessary fear among women with implants, he said. Studies have shown no increased risk of cancer, connective-tissue disease or autoimmune disorders, Fisher said.
In a study also published in the issue, Canadian researchers following the cases of 11,676 women who had undergone cosmetic breast augmentation found the women had a lower risk of breast cancer than the general population. The study suggests that the individuals monitored were already at low risk for cancer and confirms other studies indicating that implants do not substantially increase the risk, the researchers said.
