Case Study of Dow Corning 

University of Phoenix 

Ed Santana 

Paula Rogers 

Joe Timassy 

Diane Zapien 

Jessica Mercado 

Julie K. Garcia 

SOC/101 

Lauren Moulton-Beaudry 

11/13/00Dow Corning 

When breast implants were first introduced as early as 1940 they were largely inregulated, even though thousands of women a year were using them to enlarge their breast or reconstruct them after a mastectomy. In the early 1940’s Japanese prostitutes had their breast injected with substances such as paraffin, sponges and non-medical grade silicone to enlarge their breasts. One of the reasons is that Japanese women felt American servicemen favored women with large breasts. 

Originally in the early 60’s, as noted, they were used for the most part to reconstruct breasts after mastectomy surgery. When the 70’s era came breast implants were used by movie stars to enhance their looks for television and thus a trend started. Breast implants were no longer a "surgical procedure" but now a new type of surgeon came to be and that was the "cosmetic surgeon". Now breast implants were part of the procedure, which included tummy tucks, face-lifts, and lip enhancements for people of all walks of life. In the 1960’s two plastic surgeons from Texas: Frank Gerow and Thomas Cronin developed silicone filled implants which were more natural feeling and able to be shaped easier. Reports of adverse reactions to breast implants, especially silicone-filled implants, began accumulating in the Food and Drug Administration files. The FDA finally asked implant manufacturers to submit evidence of their products, however implants were allowed to remain in the marketplace despite the lack of studies. 

In April of 1992 implants were ordered off the market, however, the FDA never said they were unsafe; it only said that studies did not exist to provide evidence of how safe they were. This action occurred in the wake of several successful lawsuits against breast implant manufactures. 

Some of the Chronology of breast implants: 

1940 Japanese prostitutes have their breast injected with substances such as paraffin, sponges and non grade silicone to enlarge breasts for American servicemen. 

1960 the first silicone breast implants are developed by Two plastic surgeons from Texas: Frank Gerow and Thomas Cronin. 

1962 Timmie Jean Lindsey becomes the first woman to receive silicone breast implants. 

1976 The Food and Drug Administration enacts the Medical Devices Amendment to the Food and Cosmetic Act. But for 15 years breast implants are "grandfathered" to require proof of safety and effectiveness. 

1988 The FDA finally announced that breast implants manufactures would have to subit evidence of safety and effectiveness of the implants. 

1990 T.V reporter Connie Chung interviewed women who claimed to have disease and cancer caused by implants. She made her view that implants were dangerous devices and thus started advocacy groups, consumer groups and public awareness. 

It was in 1972 when Dow Corning’s breast implant business started to experience problems and was faced with a serious competitive threat. Five of the companies scientists left and went to a competitor, where they used their experience with silicones to develop a competitive breast implant. A few years later the same men left this company and took the knowledge and expertise they had gained from both companies and started their own company called McGhan Medical. By 1974 Dow Corning had competition in the market place.  

It wasn’t long when the new implants that McGhan Medical had developed had quickly gained favor in the market place because the implant was much softer, more responsive and almost an exact match to the natural breast. It was at this time that Dow’s marketshare began to decline and problems began to occur. 

Dow immediately put together a special task team to develop a new generation of breast implants. Because of the decline in the market place that Dow was experiencing, the team opted to cut corners and go without some of the extensive testing because several of the materials being used was similar to what the company had previously used in their Cronin implants.  

One of the problems that came to light right in the beginning is that the implants began to bleed because of the new watery gel which could bleed into surrounding tissue once placed in the woman’s body. The team reviewed the results and still believed that the bleed was not any more or less than the standard gel they had been using. Because the development of the new implants took off so rapidly Dow was able to ship several samples out to the West Coast for a Plastic Surgeons meeting for review. It was at this time that the surgeons noticed that if the implants were handled for awhile they began to feel oily to the touch. As the implants came out on the market the team started focusing more on how to market the new product rather than resolving the problems that were at hand.  

Because Dow Corning was trying to regain its market place, the company felt that if they moved at a very aggressive schedule they could bring back their market share by 50 to 60 percent. They began lowering the cost of the implants, offered rebates and free samples for surgeons. Although they were producing large quantities of the implants they were still faced with many problems. The rejection rate became very high due to floating dirt, weak bags and the walls of the implants were very thin. This created another problem where many of the surgeons had begun to return the implants back to Dow Corning. Even though many were rejected and returned the surgeons liked the product because they were much easier to insert and were more suitable for small-incisions, low-trauma cosmetic procedures. (Contemporary Business Issues, 2000) 

Cover-ups had been going on with Dow Corning since its introduction of silicone breast implants to the public in 1965. Before implants were available to the public, Dow Corning left all research aspects of silicone implants to its joint company Dow Chemical. This partnership lasted up until 1992. Dow Corning relied so much on Dow Chemical’s tests that they did not even conduct their own test until after the first implant had been inserted into a woman’s body. The problems really began for Dow in 1972 when five of its own employees went to work for Heyer Schulte, a small medical devices company. They took their knowledge from Dow and manufactured a better implant, giving Dow its first competition since implants had become available. By 1975 Dow’s market share had declined by 35 percent from the new competition. In response to the threat Dow created a task force to create and market a new and improved implant by the end of the year. In order to get a product to market this quick certain things had to be swept aside, one of these things was thorough testing. Dow said that based upon the results of the test done on the first generation of implants that none were necessary for these due to the fact that they were so similar. What Dow failed to say is that the tests on the first implants were inconclusive leaving a lot of questions unanswered about their safety. What made this so scary was that internal meeting notes show there was a concern about "bleed through" with the new implants but no studies were done. At a meeting of plastic surgeons in 1975 the implants were said to have leaked while sitting in their display case. What really put this cover up into perspective were internal memos sent by Dow’s own employees, one of which stated," The thing that is really galling is that I feel like I have been beaten by my own company instead of the competition. To put a questionable lot of mammaries on the market is inexcusable." 

Dow’s cover up of a questionable product, is a prime example of corporate greed, with a philosophy of tell the customer what they want to here. Ethically speaking it is still up for debate whether Dow was conducting itself in an improper manner. However, the only facet of the company that was not investigated by an ethical audit was the implant side. Morally this is much more cut and dry. Keith R. McKennon was named CEO of Dow in 1992, the same time the company had come under government scrutiny. He was hired to come in and clean house. This was his forte seeing as how he had done the same thing for Exxon just after their large spill in Alaska. The problem here is that McKennon should have made taking the product off the shelves priority one, not waiting for the FDA to do it for him. He should have realized that his company was playing a major role in the health of thousands of women and taken the initiative to do internal tests and investigations about the implant side of his business. Now McKennon should not be to blame for the companies morality due to the fact that he walked into a burning fire, but he should have looked at the human side of the issues before worrying about the financial. 

Widespread reports of adverse reactions to silicone gel-filled implants and a lack of evidence supporting their safety led the Food and Drug Administration (FDA) to order the implants off the market in April 1992. About 110,000 women have silicone gel-filled implants with a polyurethane coating. FDA studies showed that polyurethane foam could break down under human body conditions to form a chemical called TDA, which can cause cancer in animals. They remained available only to women in clinical studies, mostly women seeking breast reconstruction after breast cancer surgery. Saline-filled implants were allowed to remain on the market for all uses. 

A study to measure TDA in women with polyurethane implants found that a woman’s risk of cancer from exposure to TDA released by the implant is negligible, about one in a million over a lifetime. FDA considers it unlikely that even one woman would develop cancer from these implants. The study supports the agency’s original recommendation that women who are not having problems should not have the implants removed solely because of concern about cancer from TDA exposure. Replacement of gel with saline filled implants is an option for women contemplating explantation since the saline filled implants lack the potential immunostimulation of the gel filled implants. 

While a variety of health problems have been described in association with silicone breast implants, fatigue and pain are the most common complaints in women exposed to silicone. However, the relationship of these symptoms to silicone exposure remains unproven. 

Millions of women have received silicone implants, but the long-term safety of the devices has never been studied. Doctors knew that the body produces a fibrous capsule around the implant, and they thought this capsule would protect the body. But researchers have found silicone particles in the tissue surrounding the implant, and even in lymph nodes near the implant. The body produces an immune response to the silicone particles, which could damage joints. Many surgeons say the body produces an immune response to any foreign object placed in the body, but the response is usually benign. The relationship between silicone breast implants and the subsequent development of rheumatic disease remains controversial. To date, epidemiological studies have been negative. The vast majority of women with gel implants exhibit symptoms of chronic fatigue- fibromyalgia like syndrome and diseases like Scleroderma, SLE (Lupus) and Rheumatoid Arthritis. 

Silicone Implant Studies compared the rates of immune-related diseases in women with implants versus those without implants have provided reassurance that women with implants are not at a greatly increased risk of these disorders. 

In manufacturers’ studies, the events that led to removal of silicone implants from the market made it clear that studies were also needed to answer important safety questions. Implant manufacturers agreed to conduct human trials in three phases: urgent need, adjunct, and core studies. According to Sahar M. Dawisha, MD, a rheumatologist and medical officer who joined FDA’s division of general and restorative devices in April 1993; the purpose of the first phase [urgent need] was to quickly provide implants to women who were already in the process of getting them for breast reconstruction or for another medical reason, and to bridge the time until the adjunct studies were begun. However, the women did have to sign an informed consent form that summarized the risks and benefits of the implants, which had not previously been required. The second phase, studies were intended to follow reconstruction patients for five years to assess short-term safety data, including rates of capsular contracture, rupture, and complications such as infection and collection of blood that may cause swelling, pain and bruising. These studies are open to all women wanting breast reconstruction with implants, because of mastectomy, traumatic injury to the breast, or a disease or congenital disorder causing a severe breast abnormality but do not include augmentation patients. The third phase was intended to determine the full safety and effectiveness profile of the device, including rupture rates, quality-of-life benefits, extent of interference with mammography, and many more safety concerns—including rheumatologic assessments. 

According to reports, women with breast implants may have trouble breast-feeding their infants. In a study of 84 new mothers at a Texas hospital, 64 percent of those with breast implants had problems producing enough milk to feed their infants, while only 7 percent of women without implants had such problems. Among women with implants, the type of surgery they had also predicted whether they had problems with breast-feeding: women who had an incision made around their nipple were more likely to have problems producing milk than women who had an incision in the armpit or below the breast, according to the study, published in the January issue of the journal Obstetrics & Gynecology. 

According to Nancy Hurst, director of the lactation program and the human milk bank at Texas Children’s Hospital in Houston, "breast surgery most likely disrupts the nerves that are important for successful breast-feeding, normally when the baby begins to suckle, it triggers those nerves to trigger hormones to release milk, and if the nerves are severed, the volume of milk to the child may be reduced." An incision around the nipple, which is done to help make the scar less noticeable, also may sever ducts that drain milk from the mammary gland, according to Dr. Marianne Neifert, a medical consultant to the lactation program at Presbyterian/St. Luke’s Medical Center in Denver. Dr. Neifert added that even if the mother has an adequate milk supply, it may be difficult for the milk to drain into the nipple and eventually, that area of the breast will shut down and stop producing milk. Almost all of the mothers who had the surgery say this wasn’t something they were warned about. According to Dr. John William Little, president of the Plastic Surgery Education Foundation at the American Society of Plastic and Reconstructive Surgeons, the study does not prove that implant surgery interferes with breast-feeding. 

Possible Risks of Breast Implants: 

•• Autoimmune-like disorders—signs include joint pain and swelling; skin tightness, redness or swelling; swelling of hands and feet; rash; swollen glands or lymph nodes; unusual fatigue; general aching; greater chance of getting colds, viruses and flu; unusual hair loss; memory problems; headaches; muscle weakness or burning; nausea or vomiting; and irritable bowel syndrome.Recent studies have shown, however, that there is not a large increased risk of traditional autoimmune, or connective tissue disease, from silicone gel implants.Fibrositis/fibromyalgia-like disorders (pain, tenderness and stiffness of muscles, tendons and ligaments). In this study, 74% and 65% had complaints of fatigue and pain with 61% meeting the criteria for Chronic Fatigue Syndrome and 49%, Fibromyalgia, with 43% having both; not connective tissue diseases like many studies, primarily funded by the manufacturers and/or plastic surgeons looked for One hundred seventy-six patients with breast prosthetic implants were evaluated. All women were symptomatic and were referred by either attorneys (152) or physicians (24) for rheumatic evaluation. The women ranged in age from 24 to 72 with a mean of 45 years. Indications for surgery were cosmetic (128), cancer (34), and other (14). Implants had been in place for 7 years or more in 120 patients and < 2 years in only 8. Eighty-three women required explantation of their original prostheses, and 63 had new implants inserted of which 47 were silicone and 16 were saline. Capsular contractures were present in 128 women, and documented implant rupture occurred in 67. Sixty-four women underwent manual closed capsulotomies. Of the 63 revisions, 37 resulted in contractures of the new implant.The most frequent symptoms seen in the women were chronic fatigue (77%) cognitive dysfunction (65%), arthralgia (56%), dry mouth (53%), dry eye (50%), alopecia (40%), and dysphagia (35%). The most common findings on physical examination were telangiectasias (60%), erythema of the chest wall (56%), carpal tunnel syndrome (47%), petechiae (46%), lacrimal gland enlargement (26%), thyroid tenderness (22%), thyroid enlargement (21%), and parotid enlargement (18%). Laboratory findings included elevated cholesterol (59%), elevated erythrocyte sedimentation rate (32%), elevated serum immunoglobulin (28%), and positive autonuclear antibody (25%) seen most often. Despite clinical features suggesting Sjöögren’s syndrome, antibodies to Ro (SSA) were seen in only 2 patients, and antibodies to La (SSB) were seen in only 4 patients. Siliconosis is a novel systemic disease with symptoms of chronic fatigue, cognitive dysfunction, sicca syndrome, and arthralgia. 

There have been over 13,000-woman involved in a lawsuit on breast implants. The plaintiffs’ claim silicone seeped out through the flexible walls of their implants and triggers several immune system diseases. Mainly the lawsuits are against the companies that produce the implants; which are Dow Chemical and Dow Corning. Dow Chemical which supplies some of the chemicals used in the implants but did not manufacture the implants that were made and sold by Dow Corning a company that is 50 percent owned by Dow Chemical. Several of the women who sued will attempt to prove the silicone breast implants actually made them sick. Ultimately, the pay outs would range from $12,000 to $300,000 each, and Dow Corning estimates that 179,000 women around the world would be covered. An avalanche of claims from women who believed that silicone implants were making them sick drove Dow Corning to seek bankruptcy court protection from creditors in May 1995. The company and lawyers for the women announced a settlement in July. They have been working out the details since then. The negotiations were very contentious. At this point, it is a wonderful time for people to get money to get the medical care they have so badly needed. Nobody is going to get rich on this. Basically one of the most dangerous side affects of the legal medical tangle over breast implants, has been the growing skittishness it inspires among makers and suppliers of the raw material silicone. These makers fear that they could somehow be drawn into liability cases based on these or other silicone devices. 

Testimonies 

The first testimony was from Pat Wingate , she had implants for 9 years and the first 2 years were the worst for her. Within the first 2 years she started to have heart problems and high blood pressure which she never had before. She couldn’t figure out why she had practically lost control of her body. Her arms would just drop to her sides at times and she started to lose the sensation in her left side of her body. She went to her doctor when she had a strange case of the measles. But, after her doctor sent her to a Dow suspected lab they confirmed that she did in fact have the measles. But, for some reason Pat was very concerned and went to the Health Dept. and told them that she had caught a bug from an Airline employee and found out that she didn’t have the measles. She had a reaction to a Toxic chemical which eventually ended up actually making holes in her flesh from the measle like sores. 

The second testimony was from Micheline B. Lambert. Now Micheline had her implants done in 1979 which, after 2 years she had to have one of the implants removed and changed. In 1982 the same implant had to be changed twice. Finally in 1987 she finally told the doctor to just remove them.  

Ever since her first operation when she had first gotten the implant she had felt sick and still feels sick to this day even after getting the implants removed. When the doctor removed her implants he accidentally cut some nerves in her right side and ever since then she has felt a burning pain in her body as well as her arm feels as if it is paralyzed. She still has problems sleeping at night and can not even eat due to vomiting. 

In the third and final testimony from Cassandra Brouwer she started her testimony by saying how women today if the are considering getting breast implants they should gather as much information about them as they can. In the early 1970’s Cassandra was diagnosed with Fibrocystic disease. Her doctor felt that if she had implants it would prevent her from getting cancer. In 1974, she went to a plastic surgeon who used Dow Corning Cronin-type implants series 500 very thin and cheap. When the doctor was done she was very happy with the results that she had seen. 

The first month she started to notice that she was feeling pain but, just figured that it was part of the process of having implants. Then, she started to notice that her breasts were becoming very hard and that her left nipple was still sore as it was on the day of the operation. She later started to feel sick such as flu like symptoms, pain in her joints, chills in her head, and bladder and kidney infections constantly, numbness and burning in hands, and an odd smell in her nose. She later found out that she had silicone poisoning and the odd symptoms that she was getting were caused by this poisoning. 

Many of these women such as the ones mentioned above have been trying to reach out to other women who have had similar instances in their lives or who are considering breast implants. After reading these testimonies it really makes you think about how safe they really are. But, also we need to realize that there are women that are not only have a lifelong sickness from this but also have died from just having breast implants.