Fresh recall and alert records from seven new countries and one territory have been added to the International Medical Devices Database.
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.
Sybil Goldrich and Jamee Cook both suffered after getting breast implants, Sybil in 1983 and Jamee in 1998. Together, they are fighting regulators to get more information to people considering getting breast implants.
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.
In a major advance for transparency, the FDA will disclose records of patient harm and device malfunctions that had been kept buried for nearly two decades.
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.