List date(s) this work was published or aired.
4-Nov-11
Provide a brief synopsis of the story or stories, including any significant findings.
Vaginal mesh has been used in hundreds of thousands of women to treat pelvic organ prolapse and stress urinary incontinence but serious complications — from excruciating pain to nerve damage, infections and the inability to have sex — have triggered increased scrutiny by regulators. We interviewed women, former regulators and doctors to show how these devices were marketed, promoted and allowed on the market even though many patients were unaware of the safety risk.
Explain types of documents, data or Internet resources used. Were FOI or public records act requests required? How did this affect the work?
Private memos between gynecologists at the American College of Obstetricians and Gynecologist, legal documents in lawsuits, documents and data from the FDA and other government sources.
Explain types of human sources used.
Doctors, patients, ACOG staff, government staffers, regulators, device manufacturers, researchers.
Results:
Hundreds of comments and responses from readers, story posted on npr.org and aired on WBUR’s Radio Boston. Following the story, the FDA ordered 33 mesh manufacturers to conduct additional studies of the devices.
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.
No corrections or clarifications. We are following regulatory developments, other FDA actions, lawsuits.
Advice to other journalists planning a similar story or project.
Actual women who were hurt by this device are the heart of the story. But interviews with a former government surgeon detailing the financial influences that drove ACOG, the a professional organization, to revise its clinical guidelines on the use of vaginal mesh helped make the case. (The surgeon had never before spoken to the mainstream media.)