Playing with Beauty: Breast Implants, Rupture and Liability

In 1962, Cronin and Gerow introduced the very first silicone breast implants. By 1995, over 19,000 lawsuits alleging defects had been filed, eventually forcing Dow Corning (the biggest shareholder) into bankruptcy. There have since been reforms and increased regulation from Congress, but there are still many misconceptions about breast implants and liability for them if they malfunction or rupture. It is important to know your rights.

After the lawsuits in 1995, including a massive class action, silicone breast implants were actually off the market; the FDA had banned them due to safety concerns. They did not reappear in the main stream of commerce until 2006, when the FDA approved a new type of implant. However, even the new implants are not without issue. They can malfunction in three specific ways.

Rupture A breast implant ruptures when the covering tears or breaks, usually leading to a leak of silicone (or saline, depending on which type of implant).
Capsular contraction This happens when the implant is too tight, and can cause severe pain, as well as possibly changing the shape of the breast.
Infection If an implant loses its sterility, bacteria and fungus can grow, and the result can be anything from mild discomfort to toxic shock syndrome and death.

Breast implants were classified as medical devices in the 1980s, and liability for their malfunction falls under tort law; if the implant itself fails and you are not the victim of medical malpractice, you would bring a claim under a product liability theory. Product liability is when a suit alleges that a product is defective, either in design, manufacture or marketing. Usually, breast implant cases are tried as strict liability offenses, meaning that unlike in negligence law, it does not matter whether the manufacturer was careful or not; if the product is proved to be defective, the manufacturer is liable.

In Florida, the case of West v. Caterpillar Tractor Co., Inc. sets out the requirements for a strict product liability case. The three parts provide that:

There must be a relationship between the defendant and the product; that is, the defendant must have had a hand in the product’s creation or dissemination;
There must be a defect that “caused the product to be unreasonably dangerous”; and
There must have been causation; that is, the product had to have been the cause of the plaintiff’s injury.

The other theory of tort law under which these cases are tried, though it is much less common, is that of medical malpractice. The theory of medical malpractice is the most appropriate for when an implant malfunctions due to improper insertion or upkeep, rather than alleging that it was improperly designed from the very beginning. In Florida, medical malpractice law is very complex, which can serve as a deterrent to filing a claim under this theory. There is a procedure called a presuit that must be followed before a medical malpractice suit may be filed. Also, there are caps on non-economic damages (for example, damages claimed for pain and suffering), and very unusual attempts by Florida hospitals that receive government funding to claim they cannot be sued due to sovereign immunity.