In the wake of the discovery that a leading international manufacturer was found to be using industrial-grade silicone in its breast implants, questions have emerged about the regulatory process that allowed the implants and who is responsible for removing the substandard implants from women who spent thousands to get them.
John Lister, the web coordinator of AHCJ’s focus on Europe, explores the controversy surrounding the implants, including the lack of data on how many women in the United Kingdom received them, how the United Kingdom’s National Health Service has been drawn into the business of removing the implants and the regulatory system that allowed the implants in the first place. Lister reports:
But when it came to ascertaining the numbers of women who may have had PIP implants in British private clinics, it became clear there was no comprehensive or reliable data. A working estimate of 40,000 women potentially at risk eventually emerged, while the private clinics said they were not required to remove the suspect implants or replace them with safe ones. Yet the figures that were available showed that for one clinic as many as 7 percent of PIP implants had leaked, well above initial claims of a failure rate of about one percent.
The Reuters enterprise team has a special report on the breast implant scandal and a piece that shows how the regulatory system may be another scandal waiting to happen. It also looks at how, in the United States, the FDA handled an application from that company in 2000.
The history of breast implants is littered with flawed devices, a colorful cast of intertwined players and billion-dollar lawsuits. Reuters reviewed hundreds of pages of police investigation transcripts and financial documents, and interviewed former PIP employees, the company’s suppliers, customers and health experts, to piece together this latest chapter in that history.