The encyclopedia · R&D & Science · Strategic decision · 1962–2004
Dow Corning sold defective implants it knew about — 400,000 suits and a $3.2B bill
Dow Corning made the first silicone breast implants in 1962. By the 1990s, 400,000 women claimed disease. The FDA banned them and Dow Corning paid $3.2B.
Dow Corning
What happened
Dow Corning was founded in 1943 as a joint venture between Dow Chemical and Corning Glass Works to develop silicone products. In 1962, Dow Corning introduced the Cronin-Gerow silicone breast implant, the first commercially available breast implant. The product became wildly popular — by the mid-1980s, an estimated 2 million American women and 4 million worldwide had received silicone breast implants. Dow Corning dominated the market.
But internally, the company had known about safety problems for years. By 1975, Dow Corning researchers had documented that silicone gel could migrate through the body if the implant shell ruptured. The company never warned the public or the FDA. Lawsuits began in 1984, when Maria Stern won a $1.7 million verdict against Dow Corning. By 1992, the FDA had received thousands of reports of ruptures and alleged autoimmune disorders including lupus and rheumatoid arthritis. That year, the FDA imposed a moratorium on silicone-gel breast implants.
The flood of lawsuits forced Dow Corning into Chapter 11 bankruptcy in 1995 — not because it was insolvent, but to cap its liability. The company spent nine years in bankruptcy, emerging in June 2004 only after agreeing to a $3.2 billion class-action settlement trust fund. The case permanently damaged the company's reputation in clinical markets and forced it to largely withdraw from medical device sales. Independent reviews, including a 1999 Institute of Medicine study, later found no causal link between silicone implants and systemic disease, but the damage to Dow Corning was already done.
Why it happened
- Dow Corning knew silicone gel could migrate through the body if the implant shell ruptured by 1975, but never warned consumers, the FDA, or doctors — selling the product as safe for 17 more years.
- The company fought every lawsuit rather than testing its product properly. Internal documents revealed Dow Corning had suppressed safety concerns and dismissed whistleblowers for decades.
- Dow Corning filed for Ch.11 in 1995 not because it was bankrupt, but to cap its liability — spending nine years in bankruptcy while women with ruptured implants waited for compensation.
- The $3.2B settlement trust fund, created in 1998, was one of the largest product-liability settlements in history. Most of the 400,000 claimants received far less than their actual medical costs.
The lesson
A company that knows its product may cause harm but sells it anyway is not making a mistake — it is making a choice. Dow Corning chose profits over safety for 20 years and paid $3.2B.
Aftermath
Dow Corning emerged from Chapter 11 in June 2004 after nine years in bankruptcy. The $3.2B trust fund paid 400,000 claimants — most received under $1,000. Dow Corning withdrew from clinical markets and refocused on industrial silicones. In 2016 it became a wholly owned subsidiary of Dow Chemical. A 1999 Institute of Medicine study found no causal link between silicone implants and autoimmune disease, but the damage was already done.
Sources
- Wikipedia — Dow Corning (founded 1943; silicone breast implants 1962; lawsuits began 1984; Ch.11 1995–2004; $3.2B trust fund 1998; withdrew from clinical markets)
- Wikipedia — Breast implant (Cronin-Gerow implant 1962; FDA Class III 1988; FDA moratorium 1992; FDA re-approval 2006; Allergan recall 2019)
- Los Angeles Times — Dow Corning OKs $3.2-Billion Payout on Breast Implants
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