November 26, 2018 – INTERNATIONAL CONSORTIUM OF INVESTIGATIVE JOURNALISTS (ICIJ) – Manufacturers fought to get implants back on the market. Regulators gave in. Now thousands of patients are paying the price.
More than 10 million women worldwide have received breast implants over the last decade, a remarkable comeback for a medical product that had suffered a crippling safety scandal and a lengthy ban in the United States.
The U.S. Food and Drug Administration’s decision to restore silicone implants to the market in 2006 followed an earlier decision to approve the less-commonly-used saline-filled implants. It came after a furious lobbying campaign by leading manufacturers Allergan and Mentor, which convinced regulators that frequent ruptures and leaks, and an array of other ailments reported by breast implant patients, were concerns of the past.
But many of the hazards that caused breast implants to be banned in the first place never went away, a global investigation led by the International Consortium of Investigative Journalists has found.
A growing body of scientific literature links breast implants to autoimmune disorders and a rare form of cancer that has claimed more than a dozen lives worldwide.
Madris Tomes, founder and chief executive of Device Events, was one of the many contributors to this article.