Silicone breast implants: lessons from a saga.

Abstract

In the following eleven lessons learned from the silicone breast implant saga in the United States are listed. Some Lessons From The Saga Of Silicone Breast Implants In The U.S. 1. The intrinsic differences between science and the law mean that there will continue to be tension at the interface between the two. 2. Weak scientific evidence makes for weak scientific, clinical and legal judgments. 3. Health policy can influence the weighing of evidence as did the FDA ban on gel filled silicone breast implants in 1992. 4. As the probative value of scientific evidence decreases (that is, the quality and relevance of the evidence) the courts have increasing difficulty in evaluation. 5. Weak scientific evidence along with poor legal judgments can distort clinical understanding and result in harm to patients. 6. Widely publicized speculation and litigation can obscure less dramatic but frequent and serious complications. 7. Clinicans, toxicologists, industry and regulators should maintain surveillance of medical devices, in representative groups if not in all recipients of the devices. 8. The precise identity and composition of each medical device implanted into a person should be recorded both by the manufacturer and in the health care record. 9. The factual basis for informed consent should be vetted by a disinterested party. 10. Patients, clinicians and industry all have a strong interest in assuring the safety of medical devices through regulation. 11. The criteria and process for evaluating the admissibility of scientific evidence in legal proceedings have been improved but universal adoption of the improvements has not been accomplished and further changes may be necessary.