"The thing that is really galling is that is that I feel like I have been beaten by my own company instead of the competition. To put a questionable lot of mammaries [breast implants] on the market is inexcusable. . . It has to rank right up there with the Pinto gas tank. . ."
--Robert Schnabel, a Dow Corning Corporation salesman writing to his boss in 1980 after receiving complaints from a plastic surgeon that DCC's breast implants' inner gel bled through their coverings too much, and too easily.[1]
Comparisons to the Pinto gas tank disaster. . . Women screaming angrily about the Dow Corning Corporation performing experiments on humans, without their consent. . . A profitable, multi-billion dollar corporation forced into bankruptcy from thousands of lawsuits. . . All this is over a product that constituted just one percent of Dow Corning's income.[2] The breast implant controversy: is it a tale of corporate greed and its victimization of women, money-hungry attorneys, bad science, or a combination of all three?
B. Dow Corning Corporation, the Organization
Formed as a joint venture between The Dow Chemical Company and Corning Incorporated in 1943, the Dow Corning Corporation (DCC) develops and markets products that use silicones. A silicone is any compound formed by combining the element silicon with other chemicals, forming an essentially inert (i.e. unreactive) substance able to withstand extreme variations in temperature[3]. Its biggest selling point is that although very stable, silicone can be produced in many forms, from liquids to gels to solids[4]. Thus, silicones offer many possible applications.
The Dow Corning Corporation was a pioneer in the silicone products industry. Their first breakthrough was a silicone sealant used to protect Allied fighter planes' ignitions from failure at high altitudes during the Second World[5]. After the war's end, DCC earned its place as silicone market leader by developing commercial uses for silicone, varying from non-stick cookware to silly-putty to its use in medical devices such as the heart pacemaker. DCC grew from its inception in 1943 into an international organization of over eight-thousand employees, amassing sales of more than two billion dollars in 1993[6]
Along the way, DCC has not only earned the reputation as an innovator of silicone technology, but also an innovator in business ethics. DCC developed a formal Business Conduct Committee (BCC) in 1976, and published a code of ethical conduct entitled "A Matter of Integrity." The BCC was made up of DCC executives, who visited different sites annually to inform DCC employees about the values, such as integrity and honesty, discussed in the code, and also to check up on the site, allowing employees to bring any concerns to the committee's attention. Finally, the employees were encouraged to use this group as a sounding board or confidante about any practices the employee considered questionable.
C. Background on Silicone Breast Implants at Dow Corning
Part of its Medical Products Division, the breast implant was just one of several applications of silicone in medical devices. DCC had also developed a lubricant widely used on the needles of shots; material for the life-saving pacemaker; and even a hydrocephalic shunt, inserted in a child's skull to treat the fatal condition of hydrocephalitis, or "water on the brain." The first breast implant was developed in the 1960's by Thomas Cronin and Frank Gerow, plastic surgeons from the University of Texas working with DCC's Center for Aid to Medical Research. Details on the materials needed and form utilized were completed by 1962, and test implants were used by cosmetic surgeons until 1964, when the implants were officially marketed. Since the material of choice previous to the silicone gel-filled envelope was sponge, which hardened over time and was prone to infection, the new implants were a hit.
These implants were composed of a silicone gel inside an elastomer, a silicone envelope. Evidence of silicone's inertness was already well known, and a pool of research and toxicity data had been developed throughout the 1940's and 1950's. In addition, DCC completed research on tissue reaction to silicone in rats and dogs before developing the test implants. Reports on the safety of silicone were published in the research center's newsletter. For example, the January, 1960 edition published the article "Evaluation of silicones as tissue substitutes," by doctors James Barrett Brown and David A Ohlwiler, which stated: ". . . Around halogenated hydrocarbon, polyvinyl alcohol, or silicone materials implanted in over 250 small laboratory animals observed throughout the life cycle, we have seen only one questionable fibroma, and that was not associated with a silicone implant. . ." [7] The test implants were well-received by the plastic surgeons, who preferred their makeup to the unnatural sponge.
An important note here is that there were no FDA regulations on medical devices such as the breast implant at this time. No laws or regulations required DCC to perform the tests or to research the already existing information. DCC has argued that it acted like any responsible manufacturer would have in the situation. Indeed, the FDA did not begin regulating the implants until 1976.
By 1968, plastic surgeons were calling for a seamless envelope, so DCC went to work on this improvement, introducing the seamless elastomer in the same year. Also, although the Cronin-style implant was an improvement over the sponge, it still did not respond like human tissue. Thus, by the early 1970's, the consumers of breast implants were looking for a more natural version of the Cronin, and DCC had begun research to develop one, as had the rest of implant manufacturers.
Jane Johnson (pseudonym), a new chemist at DCC at this time, became a major player in the research on a more lifelike gel. When Johnson arrived, DCC had already decided to complete this process in two stages, first introducing the thinner, seamless elastomer with the same gel as previously used in 1972, while Johnson and her colleagues performed more research and testing on possible new gel formulations[8].
This research and testing followed the Product stages formalized in DCC's official "Product Staging System" by the mid 1970's. In this system, co-workers from various departments worked together on product development teams, for example, scientists with marketing representatives and sales personnel. The first stage involved classic research: DCC scientists explored ideas for silicone-related products. At the second stage, these scientists, in collaboration with other employees, developed concrete applications of the silicone material. The scientists also took a first look at the possible toxicity of the material. In order to move to Stage 3, the product team had to understand the properties of the products, its possible applications, and its safety, all by the end of Stage 2. These points were published throughout DCC before the silicone formulation could move to Stage 3. By 1973, two gel formulations had made it to Stage II, failing the precursory toxicity tests. Thus, DCC decided to limit the possible formulations to those involving only materials previously used in implants, and thus already safety- and toxicity- tested. It was under these restrictions that Johnson and her colleagues developed the new gel, which made it to Stage 3 (where the product was modeled) by December of 1974.
Stage 3 was focused on the Technology Service and Development members of the product team, scientists who developed the ideas of their Research and Development colleagues into actual product possibilities. They narrowed the possible applications, preparing scaled-up candidates for more extensive testing by the Health and Environmental Science employees. They performed biocompatability tests and completed lab sheets on the various candidates. Also during this time, the marketing department assessed the product's selling potential, narrowing the possible uses even further, in collaboration with the Technology and Service Development Employees, who had to sign off on the data sheets for the applications.
By Stage 4, the product team reviewed the information on the possible applications and the scientific data, including that related to biocompatability and safety, and made the final choice among the silicone gels. With Stage 5 would come the full-blown product and an emphasis on its marketing. Stage 6 would involve product maintenance, like designing improvements and maintaining inventory. Stage 7 would find DCC at the phase-out of the product.
Returning to December of 1974, DCC's competitors had already put some new gels on the market. Thus, DCC was eager to market its new gel implant, especially since they had been working on its development for over 3 years. In addition to the thinner elastomer and new responsive gel, they had developed new sterile packaging and wanted to introduce these three improvements in a new implant. However, before introducing it to market, DCC identified two questions which needed to be answered, as quoted by Johnson herself:
1. "Can we make this product?", and
2. "Is this product suitable for long-term implementation?"
To answer these questions, DCC assembled a special team of employees, including a biocompatability expert, a marketing employee, a manufacturing representative, a lab manager, and an experienced salesperson, commonly referred to the group as the "Mammary Task Force." Johnson worked directly with this team, which met every two weeks from December until June of 1974. Since the new gel could be produced by the manufacturing procedures already used, the team moved on to answering the second question. There were two overall opinions on how much research was required to determine the new implant's biocompatability and safety. The chemists argued that since DCC was using previously tested materials (just in new formulations), no further testing was required. In contrast the biologists emphasized the much softer consistency of the new gel, suggesting a 90-day study on it involving rats and a 2-4 week test involving monkeys.
In the interest of safety, DCC management sided with the biologists, and the tests were performed on the new responsive gel, as well as the older, firmer gel and some experimental ones. One of these experimental gels migrated from its insertion point in the monkey, a fact often brought up in today's litigation. However, this was not the gel eventually used. In fact, DCC made the specifications of acceptable gel formulations stricter in order to avoid any formulations similar to the migrating one's. Also, in an independent lab's test on the gel involving its insertion into rabbits, the lab found "`mild to occasionally moderate acute inflammatory reaction'" in the area of insertion, but the pathologists attributed this reaction to the act of insertion, not the gel[9]. Johnson and the rest of the task force determined that the new gel did not bleed through its case anymore than previous gels. The amount was approximately a thimble-ful and had not produced adverse reactions to date[10].
On the other side of the controversy, when implants with this new gel were sent to an exposition in California, DCC received complaints from its sales force that the implants developed an oily appearance after several hours on display. DCC maintained that this leakage was due to the excessive handling during the plastic surgery device show.
Given the evidence above, should the implant with the new gel have gone to market?
For more information on silicone, breast implants, current scientific studies involving implants, or other background information, please see: http://www.pbs.org/pages/frontline/implants/.
[2]Obtained during interview of Barie Carmichael, Executive Director of Corporate Communications for Dow Corning Corporation
[3] Lawrence, Anne T., "Dow Corning and the Silicone Breast Plant Implant Controversy": Case Research Journal, Vol. 13:4, 1993.
[4]Lawrence, Anne T., "Dow Corning and the Silicone Breast Plant Implant Controversy": Case Research Journal, Vol. 13:4, 1993.
[5] Lawrence, Anne T., "Dow Corning and the Silicone Breast Plant Implant Controversy": Case Research Journal, Vol. 13:4, 1993.
[6] Sellers, Charles, Goodpaster, Kenneth E., Bowie, Norman E., "Dow Corning Corporation: The Breast Implant Controversy (A)": University of St. Thomas, 1995.
[7] Brown, James Barrett, MD, & Ohlwiler, David A., MD, "Evaluation of silicones as tissue substitutes," The Bulletin of the Dow Corning Center for Aid to Medical Research: January 1960.
[8] The following information on the development of the new gel and the product stages was obtained from an interview with a Scientist at the Dow Corning Corporation .
[9] Lawrence, Anne T., "Dow Corning and the Silicone Breast Plant Implant Controversy": Case Research Journal, Vol. 13:4, 1993.
[10] Obtained during interview of Barie Carmichael, Executive Director of Corporate Communications for Dow Corning Corporation