Dow Corning Breast example essay topic

This presentation will be about the Dow Corning breast implant controversy. We will be covering the issues surrounding the breast implant controversy as well as Dow Corning involvement. The history of Dow and the implant, and the medical and legal issues will be covered. We will also touch on the history of Dow Chemical, Corning Glass Works and Dow Corning. Company history Herbert Dow in Midland, Michigan first founded Dow Chemical in 1897. Today, the company produces plastics, chemicals and agricultural products in 162 countries around the world.

In 1995 W.S. Stavropoulos was named President and CEO of Dow Chemical. In that same year, Dow sales reached a record $20.2 billion. May 18, 1997 Dow celebrated its first century of exploration and achievement. Amory Houghton bought a piece of a Cambridge, Massachusetts based glass company in 1851. Three years later Houghton acquired the Union Glass Co. in Somerset, Massachusetts. In 1864, he transferred his operation to New York City.

He then bought a glass co. called Flint Glass Works. In 1868 he moved his company again to Corning, New York. Dow Corning is a family oriented company. They have always placed their buildings around picturesque landscapes and rolling hills as well as clear lakes. Dow Corning Glass is dedicated to its over 40,000 employees worldwide, and will continue that dedication in the future. The Dow Corning co. is a leading science and technology company.

They also provide plastics and agricultural products. They have an annual sales profit of $30.000 billion dollars. Dow people around the world develop solutions using their strength in science and technology. Dow is very conscious of environmental safety by making sure their chemicals are properly contained.

By this worldwide commitment, consumers are able to lead better lives. Implant History Dow Corning developed silicone implants in the early 1960's. The first prototype that engineers developed was by encapsulating a firm dense silicone gel within a silicone rubber bag. This device was used initially and almost exclusively in reconstruction surgery performed on breast cancer patients following mastectomies. The FDA had no regulation protocol on safety, or effectiveness of implanted medical devices from the 1960's through late 1980's. The F.D.A. did not require makers of the silicone implants to submit evidence of safety, or other types of testing.

Dow Corning commissioned an independent laboratory to undertake several studies on the safety of medical grade silicone. The laboratory concluded that no evidence was found that silicone caused any harm to its recipients. Dow Corning appeared unconcerned over any health issues that were being raised. In 1972 five top-level employees of Dow Corning left the company to work for a smaller company, Heyer-Schulte a competitor of Dow Corning.

Two years later all five left to form their own company called Meghan Corporation. Armed with prior knowledge from Dow Corning, they developed a new generation of silicone implants, which was a superior product to the Dow Corning brand. The new product was softer and more lifelike. As a result of falling sales, Dow Corning swiftly developed and launched a new generation of silicone implants called flo-gel that were more comparable to the competitions. They introduced this new product without extensive testing, as they were confident that the material used was similar to those used in the previous implants. The new implants were a hit with plastic surgeons due to the ease with which they could be inserted into the body.

The number of implant surgeries increased dramatically, caused by the affordability of the implants; conversely so did the surgeons. At this time surgeons were seeing a high rejected rate on the implants, citing breakage, thin spots and contamination. As orders for the implants rose despite product problems, so did the reports of illness and injuries. These problems were now being reported at conferences, in magazines, and other consumer advocacy organizations. Because the problems were mounting, organizations were formed to bring this information to the forefront. In 1992 the F.D.A. removed the silicone implants from the market, asking the manufactures to submit evidence as to the products safety.

Medical Issues In the 1980's as the number of breast augmentation increased, conversely so did the number of reported illnesses, and injuries. One of the side effects of the silicone implants was a phenomenon know a capsular contracture. This condition results in the hardening of the breast caused by fibrous scar tissues surrounding the silicone implant. The F.D.A. estimated that severe contracture occurred in about 25 percent of all implant patients, and as many as 70 percent experienced some hardening. There were also allegations and suspicion that the silicone implants were leaking into the body causing autoimmune disorders. There are more then 100 recognized autoimmune disorders, all of which bear the distinction of being call "friendly fire" condition.

The immune system, which is meant to protect itself against viruses, bacteria, and other toxins, for some unknown reasons starts attacking the body instead of defending it (2001). According to the F.D.A. by 1991 around 600 cases of autoimmune disorders were reported by silicone implant recipients (p 344). At the time these illnesses and injuries were reported little was known about the effect the leaking silicone was having on the body. There were only a few doctors who reported on this effect and they showed no link between the illnesses and the implants. Some even went as far as to report that the autoimmune disorders were coincidental to the implants.

Unfortunately, the studies on the effects of silicone leaking into the body did not start until 1991. Doctors speculated that once the silicone implant ruptured, the silicone traveled the body via the lymphatic system, lodging in the spleen, liver and other internal organs. It was only later that the damage this caused was fully realized. Legal Issues A Nevada woman sued Dow Corning back in 1984, and was awarded $1.5 million dollars by jurors in San Francisco. The jury concluded that Dow had committed fraud by marketing their products as safe. In response Dow Corning changed the label to include a warning (Post-Lawrence-Weber 1993).

The lawsuits started pouring in, and in December of 1989 another San Francisco jury awarded $7.3 million to Ms. Marian n Hopkins. This by far was the largest victory for a plaintiff in a breast implant suit. Dow felt that their company's $250 million in insurance would be enough to cover their liability, even after Hopkins vs. Dow Corning. In 1995 the newly appointed Dow Corning president stepped in as the company was filing for bankruptcy. At that time the company was faced with over 19,000 lawsuits. Filing for bankruptcy stopped all legal action and combined all the suits into one.

Dow Corning eventually got a $3.2 billion dollar settlement out of court. This ruling freed Dow Chemical from any liability. Women from around the world may have to wait to start receiving their payments from the settlement. Some may even have to wait as long as fifteen years.

Over a ten-year span, some 170,000 women worldwide filed suits against Dow (Dominion 2001). HRG or Health Research Group, along with the Command Trust Network were instrumental in getting information, support, legal and medical referrals to implant victims. In 1988 HRG began to put pressure on the FDA (Food and Drug Administration), to ban silicone breast implants (Post-Lawrence-Weber 1993). In 1989 after extensive debate, the FDA identified silicone breast implants as Class devices and gave the manufacturers 30 months to submit safety and effectiveness data to the agency. In November of the same year, an advisory panel met once again and decided to take more testimony. But in January of 1990 a decision was made for a 45-day moratorium on all implant sales.

On February 20th the FDA advisory board recommended that the implants be taken off the market with the exception of women needing breast reconstructions (Post-Lawrence-Weber 1993). Observations There are many things that can be learned from observing how companies deal with a situation such as the one that has been spelled out here. Dow Corning has a long history of being at the forefront of innovation, quality and safety. So how did they come to be involved in such a messy situation? If we look closely at the events that led up to the eventual lawsuits, it will become evident as to what could have been done differently.

Dow was the first company to introduce breast implants into the market, and they were the sole provider of these devices for ten years. During this time, there were never any reports of medical problems. It was not until some former employees came to market with a competitive product that Dow ever considered changing the implants design. This was definitely the beginning of Dow's problems.

Instead of taking the proper amount of time to test their new design, Dow rushed the product to market in order to avoid losing too much business. Next, the first signs of problems started to show up with the new style implants. Dow makes its second mistake by ignoring these reports; the only thing we can assume is that the increasing sales figures outweighed the importance of safety. The third mistake comes when Dow finally realizes that there is a problem with the quality of the product, but fails to admit it. Dow could have cut their ultimate losses at this point by addressing the problem. Instead they try to use the logic that the burden of proving the product faulty is on the implant patient, so just deny everything and it may go away.

This stance ultimately proves very costly, as enormous amounts of lawsuits are filed against Dow. Again Dow has the opportunity to admit its product is defective, but management sticks to their original tactic of denying any problems. In the end Dow is forced to file for bankruptcy, and settles all U.S. lawsuits for $3.9 billion. The problems are not over as Dow still faces lawsuits from other countries.

Our recommendation for how this situation could have been handled differently is very simple. Never rush a product to market without proper testing and know when to cut your losses and admit there is a problem. If these two simples steps were followed, we believe that Dow would never have needed to file for bankruptcy and probably would have saved billions of dollars.

Bibliography

Blanche t, T (2001, July).
Autoimmune Disorders [online]. Available: web University of Phoenix (1999).
Contemporary business issues with readings. McGraw-Hill. Dow Chemical (2001).
This is Dow [ online] Available: web Dow Corning (2001).