The controversy over the safety of silicone breast implants was founded more on the desire to wage successful litigation with lucrative awards, than on science. It was raised more to shift public opinion in the direction of paranoia and “uncover” some sinister plot while building a “solid” career in journalism, than to extricate fact from events. The battle was a classic of example of lies repeated long enough, loud enough, and by enough visible and “educated” people to sway the opinion of juries from fact to confabulation. One thing for certain, science, fact, or truth had nothing to do with the conduct of the players. Money, greed, and ambition had everything to do with it.
Let’s begin by noting first that nothing in life is guaranteed. In allowing oneself to be implanted with breast prosthesis, a patient is permitting an unnatural act upon herself. A foreign substance is placed into a consenting body. Any foreign substance, or object will be regarded by the organism as just that, a foreign body. Any such foreign substance will incite a response, be it a breast capsule, or a more violent immune response. The question should then be restated, “how unsafe is a silicone implant?” The parties involved in condemning the use of silicone without a shred of scientific evidence effectively cheated millions of women afflicted with breast cancer out a perfectly good breast reconstruction, unless they were willing to enroll in a study. To add to the charade, millions more who had been implanted, but symptom free, had their breast implants removed. To answer the question of breast implant safety, we need to look back to the beginning…
In the 1940’s, convinced of the American GI’s penchant for large breasts, Japanese prostitutes would inject their mammary glands with various materials of dubious origin. The substances included sponge, paraffin, and silicone. Fast forward to the 1960’s. Doctors Gerow and Cronin began implanting silicone breast prostheses in Houston. In 1976, the silicone breast implant, along with all other medical devices came under the jurisdiction of the Food and Drug Administration in an amendment of the Federal Food, Drug, and Cosmetic Act. Because silicone implants were in use for years prior to the enactment of the amendment, the only requirement imposed on their producers was the provision of safety data on FDA’s demand. In 1977, the first settlement from Dow was furnished to a patient with “pain and suffering” as a result of implant rupture requiring multiple revisions. In the 1980’s, Ralph Nader’s Public Citizen Health Research Group began implicating silicone breast implants in the etiology of breast cancer. As is the case with many of Mr. Nader’s allegations today, the statements were based on anecdotal “evidence.” This is the type of proof the scientific community regards as equivalent to no proof, and the type our attorney friends call hearsay. As a result of the dissemination of this propaganda, in 1982, the Food and Drug Administration suggested that silicone breast implant producers demonstrate conclusively the safety of silicone breast implantation, placing the device into category III. In 1984, Maria Stern was awarded 211k in compensatory, and 1.5m in “punitive” “damages.” The charade put on by Dan Bolton, her “attorney,” included the testimony of theorizing “experts,” who through their “expertise,” but without the burden of true scientific research or proof of any kind, linked breast cancer with silicone. The 1982 category III re-classification proposal materialized in 1988, with the premarket approval applications (PMA) due date set in July of 1991. The FDA would then review the applicants’ data over the following six months. Prior to any such due process, however, the case for the silicone implant was “reviewed”, no doubt after exhaustive “research,” by Connie Chung on “Face to Face.” Sensationalism sells, and Connie’s brand sold particularly well. Without regard for truth, and based entirely on a handful of anecdotal reports and cases, she effectively paraded women who claimed to contract autoimmune disease from breast implants, in the process fueling the baseless paranoia. It is quite unfortunate, and very sad that these patients were sick. It is even more unfortunate that a third party was able to use them to capitalize on emotions stirred up in the public. The “good” journalist never stopped to think that of the millions of women who had silicone implants placed, some were bound to be affected by autoimmune disease at the rate of the general population. Truth, however, seldom makes careers. At around the same time Ralph Nader’s “Public Citizen” jumped on the band wagon, aided Dr. Sidney Wolfe, stoking the flames and pressing in courts, while Representative Ted Weiss headed a Congressional Hearing on the safety of silicone breast implants. It is interesting that a court order from the Stern hearing barred the presentation of certain evidence for publi
