Breast Implant Case Study

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 1970’s.

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 weren’t 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...