1960s: Breast implants were first sold in the US, before the FDA regulated medical devices.
1976: Law changed, meaning that every medical device would be categorized into class I, II or III.
Those in the highest class (Class III) would require the most stringent checks – mainly: human clinical trials.
Breast implants, growing in popularity, were allowed to stay on the market while the FDA decided which category it should take.
But doctors started raising concerns in that the devices seemed to trigger side effects.
1978: An FDA advisory panel suggested breast implants should be Class II.
1982: The FDA decided breast implants should be Class III. They called on industry to conduct human studies to investigate a few main concerns:
- the risk of rupture
- the risk of leaks
- scars contracting
- that they are hard to mammogram
- links to lupus
- links to cancer
1990: Congressmen berated industry for failing to present human trials. The only trials to date were silicone injections in rats and rabbits.
1991: Industry submitted human studies but they were deemed poor quality. One only lasted three months.
1992: Internal documents from people inside the industry leader at the time, Dow Corning, were leaked to the press, showing that manufacturers had concerns of risks to human health.
That was the nail in the coffin. The FDA decided to ban silicone implants for women unless they were part of ‘adjunct’ trials to assess their safety.
2003/4: The FDA rejected the data presented by Inamed (now called Allergan) and Mentor (now part of J&J), saying they were poor quality. Seventy-five percent of women dropped out of the Mentor trial before their first follow-up.
The FDA then published guidance on what the trials should consist of. They needed to answer why implants break, leak, and how long implants last.
2005: Mentor and Inamed submitted three-year-long studies, which were criticized as inadequate by the FDA.
2006: The FDA re-approved silicone implants, but ordered device makers to conduct six trials spanning 10 years with at least 40,000 women.
2011: No data had been published. The National Center for Health Research, a patient advocacy group, lobbied congress for answers. The FDA published data online later that year, showing the studies were not completed. Three-quarters of women dropped out of the Mentor study, and 40 percent dropped out of the Allergan study.