Dow Corning Breast Implant Controversy
Running head: DOW CORNING CORPORATION Dow Corning Corporation and the Breast Implant Controversy Angela Collinson Lesley Hayduska Deb McDonnell Kandis Schraeder College of Saint Mary Dow Corning Corporation and the Breast Implant Controversy Introduction Dow Corning Corporation (Dow Corning) was incorporated as a joint venture between Dow Chemical and Corning Glass Works (now Corning Incorporated) in 1943. Dow Corning became involved in the medical production services in the early 1950’s creating silicone implant products such as pace makers and silicone tubing. Silicone breast implants were developed and marketed by Dow Corning in 1963. Since the Federal Government had not yet begun to regulate medical devices, Dow Corning had free reign to begin selling the silicone implants to plastic surgeons with no proof of safety. Problems began for Dow Corning in 1981, when several women reported medical complications attributed to their silicone breast implants. These women sought damages from Dow Corning as well as other silicone implant manufacturers. During the trials that followed, Dow Corning was found liable for the damages allegedly caused by silicone breast implants. In 1992, silicone breast implants were taken off the market and in 1995, Dow Corning filed Chapter 11 bankruptcy. History In 1943, Corning Glass Works and Dow Chemical Corporation joined forces during World War II to produce silicone products for the war effort. The basic silicone technology was maintained by Corning Incorporated and Dow Chemical was responsible for supplying the chemical processing and manufacturing expertise. Dow Corning began to research the use of silicone in various types of medical implants. The great potential and flow of new medical products motivated Dow Corning to set up a separate division focusing on medical devices in 1963 (Brand and Keller, 1994). That same year Dow Corning began producing silicone breast implants. The FDA had no regulation standards for the safety of medical devices until 1976, so Dow Corning began marketing the silicone implants to plastic surgeons through medical conferences, presentations and articles. ... By 1980, however, analysts estimated that 80% of silicone implants were for breast augmentation while the remaining 20% were for reconstructive purposes. The average cost to the patient ranged from $2,000-$3,500, while the silicone implant itself cost between $200 and $300, showing a substantial financial profit to both doctors and silicone breast implant manufacturers (Brand and Keller, 1994). In 1975, five Dow Corning sales representatives were recruited by Donald McGahn to launch a new company producing silicone breast implants using technology taken from Dow Corning. ... Silicone breast implants were “grand fathered” in due to the fact that silicone implants had been on the market for 15 years (Unknown Author, PBS website, para. ... Silicone implants being “grand fathered” into the FDA Cosmetic Act coupled with competition from rival medical companies producing silicone implants, prompted Dow Corning to develop a ‘new and improved’ silicone implant with a different (silicone) envelope and a more ‘natural feeling’ liquid silicone gel. This helped Dow Corning regain the majority of the silicone breast implant market and by 1980 was the leader in silicone breast implant manufacturing. Problems Doctors were excited about the initial silicone breast implants, but sales people noted that the product became oily from gel bleed during presentation. Tom Salisbury, Dow Corning Marketing Executive, advised the sales people to wash the implant before the presentation and also noted in a sales memo, “Keep in mind this is not a product problem” (Brand and Keller, 1994). One year before Dow Corning Company began selling silicone implants, the company was advised by its own Center for Aid to Medical Research that silicone will bleed through a silicone bag and be absorbed into human tissue (Letter from Ethel Mullison to Dr. ... Despite this, in 1963, Dow Corning began selling the silicone implants without long-term testing or monitoring of the women who received the silicone implants. In 1975, Dow Corning began selling its new and improved silicone implant. Plastic surgeons complained to Dow Corning Company that the new silicone implants were oily and leaking even before they were inserted. Two more employees of Dow Corning expressed great concern over the safety of the silicone implants to their superiors. ... William Boley, Dow Corning’s Chief of Biomaterials Safety, stated that it is highly probable that a woman’s onset of Lupus is connected to silicone implants.