List date(s) this work was published or aired.
27-Jun-11
Provide a brief synopsis of the story or stories, including any significant findings.
It was previously thought that the science behind silicone-gel breast implants has been refined to the point where a woman could receive the implants in her twenties, thirties and forties, and expect to safety wear them (without replacement) through her lifetime. But follow-up trials and data collection required by FDA and gathered by the two U.S. manufacturers of the implants, have clarified that this isn’t actually the case, and that in fact, many women will experience enough trouble with their breast implants, that they will have to return to their docs about once every 10 years, and perhaps need to get their implants replaced. This is problematic, since life expectancy for the average woman in the U.S. is over eighty! The other disturbing fact this story uncovers, is that the two firms required by FDA to conduct post-market on breast implant recipients — DID NOT FULLY DO THEIR HOMEWORK, and were only able to track down 21% of some of the recipients for one type of implant, and 45% for another. This totally skews the statistical outcome of the post-market trial. There could be literally hundreds of women walking around with breast implants, who HAVE NOT been followed up on, and therefore, regulators have no way of knowing all the potential adverse effects that the implants could have caused.
Explain types of documents, data or Internet resources used. Were FOI or public records act requests required? How did this affect the work?
In addition to listening to and recording the FDA press briefing held by device office official Jeff Shuren, I followed up by calling the agency and asking additional questions of spokespersons, and by reading the long report accompanying the press release.
Explain types of human sources used.
FDA officials, FDA spokespersons.
Results:
This issue of the safety of silicone breast plants just won’t go away (both domestically and internationally), and we at “The Gray Sheet” continue to follow the connected science, events and controversy, as it unfolds.
Follow-up (if any). Have you run a correction or clarification on the report or has anyone come forward to challenge its accuracy? If so, please explain.
Neither FDA nor manufacturers have asked for clarifications.
Advice to other journalists planning a similar story or project.
Read the full report connected to any agency press briefing, and ask lots of questions. FDA Official Jeff Shuren presented his data in a very low-key way, but the findings at the agency were very dramatic, both for women with the implants, and for manufacturers.