A good measure of common sense and logic is the fundamental keystone to basic research. There is no doubt that Dow Corning knew since 1963 that their gel-filled breast implants were losing liquid silicone. Their scientists' immediate objective should have been to determine where liquid silicone migrates to and what effect it had on vital organs. In the mid 1960s, Tom Talcott, their own chemical engineer, expressed concern and advised them to initiate some specific research in this direction. The mere idea that such research could possibly expose the real dangers of liquid silicone apparently persuaded them to conveniently eliminate Talcott.

As described in the previous chapter, Dow Corning's entire research was summarized and presented at the FDA meeting on July 6, 1978, by Dow Corning's top researchers, Mr. Arthur Rathjen, who has a bachelor's degree in English and Dr. LeVier, who has a Ph.D. in Endocrinology. When Dr. Jarrold Abraham, a reputable pathologist, specifically asked LeVier, if in the autopsies of the animals, he had looked for silicone levels in the different tissues, LeVier's answer was: "No, we did not." LeVier claimed that their research showed only inflammatory reactions to the implants. Abraham, who had consistently found foreign body reactions rather than inflammatory ones, asked if this could be due to particle size, LeVier answered: "Most probably, yes." Abraham then suggested that they grind up the envelope material, which, in his opinion, had a much greater chance to elicit a local foreign body reaction. In early 1993, John O. Naim, Ph.D. Director of the Surgical Research Laboratory of Rochester General Hospital did exactly that. Ground-up elastomer envelope material caused a localized foreign body reaction. The gel-liquid silicone mixture, on the other hand, caused a more severe systemic reaction than Freund's adjuvant.

In the years following 1963, any plastic surgeon with common sense should have realized that silicone gel-filled breast implants were losing considerable qualities of liquid silicone into their patients. As a matter of fact, in 1965 and 1966, when I was a senior resident in plastic surgery at the Henry Ford Hospital, I assisted Dr. Alex Kelly, Chief of the department, in a few explantation surgeries. I vividly remember how difficult surgery became due to the slippery surgical instruments which had become covered with liquid silicone. The gross contamination of the wound with liquid silicone so impressed me that I contacted some of the representatives of Dow Corning and pleaded with them to make a safer alternative to the gel-filled breast implant. I offered them my idea to manufacture a saline-filled breast implant which would not contain any gel or liquid silicone. I also explained to them that such an implant would reduce the total amount of foreign body in a woman by at least 90%.

In the early 1970s, a group of pathologists of the Palm Springs Valley Laboratory examined scar tissues of patients whose intact gel-filled implants I had explanted. Silicone micro-droplets were found to be present throughout the pseudocapsule and in the adjacent breast tissue. They also observed a local foreign body reaction around the silicone implants. In some instances they reported the presence of a foreign body granuloma which we eventually referred to as "siliconoma."

Tissues obtained from a different group of patients who previously had liquid silicone injections into their breasts, showed identical histological changes. In the latter group, however, the presence of silicone micro-droplets was much more massive and liquid silicone seemed to infiltrate the most superficial layers of the skin. This work was to be presented by me to the FDA on March 24, 1978, and was confirmed by Pathologist Abraham on July 6, 1978.

This histological picture reminded us more and more of an infiltration and dissemination observed in inflammatory carcinoma of the breast. Liquid silicone was disseminated by ways of phagocytosis, (transportation by macrophages) and by direct drainage into the lymphatic system. The only thing left to prove was the actual diffusion of silicone micro-droplets into the vascular system.

After attending a meeting of the Swiss National Society of Plastic and Reconstructive Surgeons, I met with Dr. Jiri Smahel, who had done some histological work on silicone and polyurethane. This excellent researcher at the University of Zurich had been able to demonstrate solid particles of polyurethane in the mammary gland and in the milk duct. He also had been able to prove the presence of micro-droplets of silicone in lymph nodes.

After further discussions and a visit with him at his research laboratory, he too realized the importance of being able to show the actual presence of silicone micro-droplets within small blood vessels. He asked me to supply him with some intact pseudocapsules containing non-ruptured silicone gel-filled Dow Corning breast implants. Since many patients came to me for removal of their gel-filled breast implants inserted by other plastic surgeons, it was not long before I had collected an adequate number of such specimens. These were carefully preserved in a Formalin solution. Smahel was to be provided with exact and detailed clinical information about each patient, whose pseudocapsule he was to examine. With all necessary material packed in my carry-on luggage, I flew to Zurich to meet with Smahel.

In a meticulous and ingenious way, Smahel started to literally peel layer after layer from the scar tissue surrounding the implant. Instead of the routine and standard cross sections, he was able to make tangential cuts. Finally one of the many hundred sections had cut a small capillary lengthwise. The properly stained histological section only showed red corpuscles, but also demonstrated a string of silicone micro-droplets, with the capillary, looking like a strand of pearls.

This was the missing link. We had now proved for the first time that liquid silicone from an intact silicone gel-filled Dow Corning breast implant had transgressed the silicone elastomer of the prosthetic envelope, penetrated the full thickness of the pseudocapsule and had actually entered the capillaries surrounding the pseudocapsule. This very important discovery did not come as a surprise.

Red corpuscles measure 7 microns in diameter. Silicone micro-droplets dispersed into human tissues measure between 0.1 and 10 microns. These droplets enter and exit through the pores of capillaries with great ease. It is only logical to conclude that intravascular silicone micro-droplets will be pumped into the entire body. Once the blood has reached end-arteries or very small capillaries in vital organs, these silicone micro-droplets either migrate out of the blood vessels into the surrounding tissue or obstruct the vessels. As Abraham pointed out to the FDA and Dow Corning scientists in July of 1978, these micro-droplets will exert pressure on the surrounding tissue. It should therefore not come as a surprise that many women will experience very strange and changing symptoms, sometimes ten to fifteen years after their breast implant operation.

In 1978 I sent the FDA a true copy of the entire scientific work with color prints of the original histological sections. On October 31, 1978, I followed up with a letter to Dr. Mark Parrish, Executive Secretary of the FDA. I asked him to warn patients of possible severe and irreversible complications. I implored the FDA to immediately stop production and sale of all silicone gel-filled implants, until such time that an impermeable envelope was developed or until a non-leachable silicone gel could be produced.

After considerable difficulties in trying to publish our paper in the official Journal of the American Society of Plastic and Reconstructive Surgeons, Inc. in the United States, we finally were successful in having it accepted in 1981 in a journal called, Aesthetic Plastic Surgery, published in Stuttgart, Germany.

The FDA's rules and regulations appeared more and more contradictory. On one hand they never legalized the use of liquid silicone in humans. On the other hand they tolerated a silicone gel-filled breast implant, delivering unapproved liquid silicone into the women's body continuously from the day of implantation until the day of explantation. This product is a drug delivery system in its truest sense. As I explained to the FDA and to my professional colleagues at national and international meetings, we were dealing with a true pollutant. It was clear to me from the beginning that this type of body contamination with silicone, best called siliconosis, was an irreversible process. As civilized man has mindlessly polluted his environment, so have plastic surgeons irreversibly polluted the body of over two million women worldwide with a pollutant called silicone. ***From the book, "Silicone Gate" by Henry Jenny M.D.