Healthcare

The International Medical Devices Database now covers 26 countries
Emilia Díaz-Struck and Amy Wilson-Chapman · May 15, 2019

Fresh recall and alert records from seven new countries and one territory have been added to the International Medical Devices Database.

US Halts Sale of Vaginal Mesh Blamed for Thousands of Injuries
Sasha Chavkin · April 16, 2019

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 Announces Medical Device Action Plan to Address Patient Concerns
Will Fitzgibbon · April 8, 2019

Australia’s regulator has pledged to fast-track safety reforms and improve transparency, but critics have said their plan lacks substance and detail.

The 30-year Fight For Breast Implant Safety
Scilla Alecci · April 8, 2019

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.

Canada Halts Sales of Cancer-Linked Breast Implants, as Global Scrutiny Grows
Sasha Chavkin · April 4, 2019

A growing wave of regulators are reconsidering the safety of textured breast implants that have been associated with a higher risk of cancer.

France Bans Breast Implants Linked to Heightened Cancer Risk
Sasha Chavkin · April 3, 2019

French health authorities have informed manufacturers of a sweeping and historic ban on two categories of breast implants.

Italy Announces Medical Device Registries After Implant Files
Scilla Alecci · April 1, 2019

Italy will launch registries for breast implants and orthopedic devices after the Implant Files exposed flaws in the country’s regulatory system.

US To Disclose Records Tracking Millions Of Medical Device Problems
Sasha Chavkin · March 27, 2019

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.

FDA Kept Hundreds of Thousands of Breast Implant Incidents Hidden From Public
Sasha Chavkin · March 25, 2019

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.