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Timeline: Silicone implants



  • After years in the making, gel-filled silicone implants are developed in 1961 and introduced to the market, first by Dow Corning Corp. in 1962. Other companies follow.


  • Silicone implants are among the most popular form of breast implants next to saline-filled ones, as hundreds of thousands of women elect to have implant surgery.

  • In 1977, a Cleveland woman is the first to sue and win a $170,000 suit against Dow Corning, claiming her ruptured silicone implants caused her pain and suffering.


  • More lawsuits trickle into courts, as the Washington-based Public Citizen Health Research Group warns that silicone breast implants cause cancer. Federal Drug Administration begins monitoring silicone implants. Increased reports of women's health issues attribute their cause to silicone implants.


  • Lawsuits continue to mount against such manufacturers as Dow Corning, 3M, and Bristol-Myers Squibb. In 1991, one woman in San Francisco is awarded $7.3 million--the largest to date--in a case against Dow Corning after claiming silicone implants caused her connective tissue disease.

  • In 1992, FDA issues moratorium on silicone implants but lets companies sell products to women undergoing reconstructive surgery following cancer who are monitored by the companies following surgery. Dow Corning, the largest manufacturer, stops making silicone implants.

  • By 1994, an estimated 19,000 suits are filed against Dow Corning. A class action against all manufacturers is filed and settled for $4.25 billion. More than 400,000 women signed up to benefit from lawsuit, most of them claiming their silicone implants created health problems.

  • In 1995 Dow Corning files for bankruptcy.

  • Throughout the late 1990s numerous studies--including those out of Harvard University and the American College of Rheumatology--find no disease-link to silicone implants. The FDA and other organizations continue to study silicone implants.

  • By 1996, in several suits, courts begin ruling that silicone implants are not related to plaintiffs' health issues. Various state appellate courts divide on the issue.


  • By 2000, FDA allows two companies--Allergan Inc. and Mentor Corp.--to study silicone implants in a limited number of patients. FDA monitors studies.

  • Both companies by 2003 apply to the FDA to begin widely marketing their silicone implants.

  • FDA approves both products in preliminary decision in 2005.

  • On Nov. 17, 2006, FDA issues final approval for both companies to market products on the condition that they continue to study the implants in 40,000 patients over 10 years.

    Source: FDA and news reports