The ICIJ-led investigation exposed serious flaws in the multi-billion-dollar global medical device industry, including patchwork regulation and oversight gaps worldwide.
The new FDA guideline is meant to alert patients to the health risks of breast implants, which have been associated with serious illnesses, ICIJ’s Implant Files investigation found.
Frustrated by FDA delays, some survivors are promoting laws to require informed consent before breast implant surgery in at least six states.
Tens of thousands of women claimed they suffered severe health problems after being implanted with the contraceptive device.
Only a fraction of incidents in which women were allegedly harmed by the contraceptive device were reported, experts in California cases claim.
A new study in a leading plastic surgery journal offers more evidence to support the existence of breast implant illness.
A controversial therapy for children with curved spines that featured in the Implant Files investigation has been banned in the United Kingdom.
Patients who suffered debilitating immune reactions after being implanted with metal-containing devices have joined doctors, scientists and industry representatives to testify before a United States government advisory panel.
U.S. health authorities have recommended that breast implant manufacturers provide stronger patient safety warnings.
Nearly one year after the Implant Files, India’s health ministry plans to register and regulate medical devices the same way it does drugs.
Allergan will recall its Biocell textured breast implants worldwide due to their association with a rare cancer of the immune system.
Australian authorities have proposed to ban or suspend 25 models of breast implants due to their association with elevated risks of a rare cancer.
Tens of thousands of confidential accident reports have been kept from doctors and patients every year, but some may get released.
Canada has become the latest country to halt the sale of textured breast implants linked to an increased risk of rare cancer.
The United States decided not to ban a breast implant that has been linked to an increased risk of cancer and is being removed from the market in France, Canada and other countries.
The United States has banned the use of vaginal mesh for the treatment of pelvic organ prolapse, the U.S. Food and Drug Administration announced.
Australia’s regulator has pledged to fast-track safety reforms and improve transparency, but critics have said their plan lacks substance and detail.
A growing wave of regulators are reconsidering the safety of textured breast implants that have been associated with a higher risk of cancer.
French health authorities have informed manufacturers of a sweeping and historic ban on two categories of breast implants.
Italy will launch registries for breast implants and orthopedic devices after the Implant Files exposed flaws in the country’s regulatory system.
On the eve of a hearing about breast implant safety, the U.S. regulator revealed it has long known about vastly more complications than previously disclosed.
The FDA has announced a fresh probe into adverse patient reactions to materials used in breast implants, metal-on-metal hips and birth control coil Essure.
A French inquiry is calling for sweeping reforms of medical devices regulation in France and across Europe, branding the current system “massively dysfunctional."
One of the biggest manufacturers of vaginal mesh implants, C.R. Bard, is ending all production and marketing of the controversial products.
Belgian authorities are investigating allegations that surgeons received bribes to favor certain brands of medical devices, amid accusations that the practice is rife across Europe.