Controversy

Lawsuits
By the late 1990s, tens of thousands of lawsuits had been filed against implant manufacturers, most notably Dow Corning (see Dow Corning Litigation Information). Over $3 billion in settlements have been awarded in cases and class action suits regarding silicone breast implants. For a complete timeline of the silicone breast implant courtroom battles, check out PBS: Chronology of Silicone Breast Implants.
Breast implants first appeared in clinical circles in 1960. Two years later, Timmie Jean Lindsey became the first woman to undergo breast augmentation surgery using silicone breast implants.

The 30 years following Timmie Jean Lindsey's successful breast augmentation saw endless courtroom battles over the safety of silicone breast implants. When a silicone implant ruptures, medical-grade silicone is absorbed into a woman's system. The effects of this absorption are unclear.

Industry officials, consumer-advocate groups and interested third parties have tapped experts in all applicable medical fields to study the side effects of silicone breast implants. None of these studies could produce compelling evidence that either confirmed or denied a connection between silicone implants and illness. A congressional hearing held on the matter failed to turn up any conclusive results.

In 1992, FDA Commissioner David Kessler asked implant manufacturers to affect a voluntary moratorium on the sales and distribution of silicone breast implants in the United States. Since then, silicone breast implants have been available in the United States only in special circumstances:

  • If they are part of a breast reconstruction due to mastectomy (a medical procedure to remove part or all of a woman's breast to prevent the spread of breast cancer)
  • If they are meant to replace saline implants in a revision surgery due to complication
  • If the patient has agreed to be part of clinical trials for five to 10 years after surgery
FDA-approved saline implants are made the same way as their silicone predecessors but are instead filled with a sterile mixture of salt and water. However, the switch to saline was hardly a perfect solution: Women with saline implants have complained that they produce an unnatural look and feel, and some women have had saline implants removed due to dissatisfaction or complications. To this day, the debate rages on the pros and cons of saline versus silicone.

To read the results of some of the independent studies done on the side effects of silicone breast implants, check out the links below:

For more information on implants, augmentation and other breast surgeries, check out the links on the next page.