The Business Ethics Blog

Students & scholars of business ethics must have all arched their eyebrows in unison recently, as it was announced recently that the FDA (in the U.S.) and Health Canada had both decided to permit — for the first time since the early 1990s — the marketing of silicone breast implants. The announcement is noteworthy in part because the breast implant story is one of the classic business ethics case studies.

During the 1980s and 1990’s, the implants were accused of leaking and causing a range of ailments (including cancer, autoimmune disease, arthritis, etc); and the makers of the implants were accused of knowing about it and of ignoring the evidence in the name of profit. The story involves a complicated mix of pathos, controverted science, women’s health, and profits. To many, it seemed like a clear case of a corporation putting profits ahead of health. But there also seem to be serious doubts about the scientific validity of the safety concerns. See, for example, this NY Times story from 1999 about a report from the Institute of Medicine: “An independent panel of 13 scientists convened by the Institute of Medicine at the request of Congress has concluded that silicone breast implants do not cause any major diseases.”

Still, the nature of the product involved is bound to leave many with doubts about the ethics of marketing it. Set aside, for now, questions about the sale of a product which, when used for cosmetic (as opposed to reconstructive) purposes, may contribute to perpetuating unhealthy ideals of female beauty. Feminist concerns aside, just consider that cosmetic breast implants are not exactly a life-saving pharmaceutical. We might (might!) interpret the science generously when the product in question is going to save lives. Most powerful pharmaceuticals come with risks, but in most cases we hope the risks are worth it. How much risk does there really have to be in order to cast doubt upon the sale of bigger boobs?

Here’s last week’s story, from the NY Times: The Return of Silicone Breast Implants

The silicone implants were largely banned in 1992 because the manufacturers could not prove they were safe and effective after health concerns arose. A barrage of lawsuits drove the main manufacturer into bankruptcy and led to payments worth billions of dollars to women who said they were harmed. But over the years a series of assessments concluded that the main fears were overblown. The implants did not appear to cause such major diseases as cancer, rheumatoid arthritis, immunological diseases or neurological problems.

That does not mean they are risk free. In approving the silicone implants made by two companies, the F.D.A. said simply that it had “reasonable assurance” that the devices were safe and effective, not ironclad proof. It approved the devices for cosmetic breast augmentation in women age 22 and older and for breast reconstruction in women of all ages whose breasts have been disfigured or removed for medical reasons. But it heaped on enough caveats to give women ample reason to pause before leaping into cosmetic breast surgery.

(Dow Corning, the biggest manufacturer of implants, left the business under a cloud of controversy in 1992, as did Bristol-Myers Squibb and Bioplasty. The companies who sought, and just received, FDA and Health Canada approval, are called Mentor and Allergan.)

Further Resources:

• Here’s a 1994 story about the orginal Dow case, by Andrew W. Singer, from when the case was still fresh.
• Here’s a timeline of the breast implant saga from Frontline (through 1999)
• Here’s Allergan’s press release about Health Canada’s recent decision.
• Here’s information on the decision to license silicone breast implants, from Health Canada.
• See also Marcia Angell’s 1997 book, Science on Trial: The Clash of Medical Evidence and the Law in the Breast Implant Case

[Note: it took forever to find the image above for use in this blog entry. Apparently, googling the term “breast implants” mostly doesn’t get you clinical images of medical devices. It gets you pictures of Pam Anderson. Go figure.]