The Breast Implant Controversy (1) Summary In 1962 Dow Corning of Midland, Michigan a subsidiary of Dow Chemical developed

silicone breast implants. Over the years the device was improved to lessen the bleed and to minimize capsular contraction. 1976 FDA was given regulatory authority over medical devices; the implants were grandfathered in without the requisite studies of newer products. Health hazards associated with the silicone implants came to light gradually, over years, lawsuits, media coverage. In 1991 Business Week ran an article suggesting that Dow knew of potential risks their implants were causing women as early as the 1970s. November 1991, to address the concerns the FDA convened an advisory panel on medical devices. Included plastic surgeons, medical experts, representatives from each of the manufacturers and consumers. The FDA responded by calling for a temporary moratorium on selling the devices because they could not assure their safety with the information provided in the (PMA) premarket approval application. Stocks fell immediately. Doctors said this will cause mass hysteria amongst women. Documents leaked to the press suggested that Dow Corning might have known of the product's risks for several years. February 1992, panel met again and suggested the implants not be banned but be severely restricted in their use. New York Times Insufficient evidence that the implants were safe and effective. Wall Street Journal No evidence of harm, but more research would help. Breast implants were restricted not banned; they werent safe but caused no harm? Even before the FDA issued its final ruling in April Dow announced in mid-march that it would stop making and selling silicone gel breast implants. Skip ahead two years The reason why they were banned, the FDA banned the implants not on the grounds that they were unsafe but that the manufacturers, despite decades of selling the devices had failed to conduct the studies needed to show their safety and effectiveness. January 1992 FDA We still do not know how often the implants leak; and when they do, we do not know exactly what materials get into the body. We still do not know how often the implants break or how long they last.

For a product that had been on the market for over thirty years and which was implanted in millions of customers, it was worrisome that the company had no real estimate of the lifetime of the product. Percentages from different studies were a tenth of a percent to 5 or more percent. The companys reputation suffered grievously. By March 1992, the common view of the company in the public mind was that its devices were not safe, that it had covered up evidence about their safety, that it was insensitive, and that its actions amounted to a 30year medical experiment on women who were uninformed as to the risks. There was a lack of crisis-management leadership. (2) Strategy employed by the firm Through their Product Replacement Expense Program, the company guaranteed to pay for removal or replacement of their product due to the loss of product shell integrity within five years of implantation. Why so short no good answer from Dow. Did the company doubt its own forecasts? If rupture rates were so low, why would the company limit the warranty so dramatically? Was the company not telling the public the real risk of rupture? Dr. Baily Lipscomb, Director of Clinical and Regulatory Affairs took the stage and did not address the problem; he was too busy trying to protect the company. He did not talk about what the company would do going forward, only what it had already done. There was managements inability to gauge the publics perceptions, too. Dow Cornings position was and is that all the scientific evidence was still not in regarding the safety of silicone breast implants. Technically, this is correct. But meanwhile the company was losing the battle in public opinion. It was seen as a callous corporation, indifferent to the plight of its products end users. February 1992, Dows new CEO Keith R. McKinnon (veteran of dioxin and agent orange controversies) Told the press such unconventional things such as, For me and Dow, the overriding responsibility is to the women who have implants if it hasnt been clear until now, we are going to cooperate absolutely with the FDA, and that means we are going to quit complaining about who is non the advisory panel and all that. After putting safety first, instead of trying to defend the company, McKennon offered a plan for addressing the concerns of its customers. The company track had changed: Dow was no longer minimizing concern; instead they were seeking to minimize risk. He had legitimized womens fears and concerns. This came too late. His commitment to honor the FDA requests for information was broken several months later. Hired a lawyer who refused to hand over finding to the FDA.

(3) What did the firm do correctly? Nothing. (4) What would you recommend? Listen to the concerns of the public and acknowledge them. Get information to the press so there are no inconsistencies with stories being reported. Take blame from the start; acknowledge inconsistencies with testing methods and interpretation and vow to the public to get the correct most factual information to them. Offer a 30 year (or some larger amount) warranty period instead of the 5. The 5 years just made the public more skeptical. A company must establish and state clear and believable standards of performance if the public is worried about the risk. There ought to be some explainable basis for proposed performance standards. Develop a forum for consensus building. Multiple meetings over a longer period of time. Involve stakeholders in decisions; never ever have approved taking the implants off of the market. Develop ways to minimize the risks of mammographic interference. Develop better informed pamphlets for people considering the surgeries. Give insurance guarantees that will alter perceived risks.