Healthcare

FDA Releases Vast Trove of Hidden Medical Device Injury and Malfunction Reports
Ben Hallman · June 24, 2019

Manufacturers will no longer be allowed to conceal serious injuries and other malfunctions associated with implants and other medical products, from breast implants to surgical staplers from public view.

European health ministers fight to postpone medical device safety laws
Simon Bowers · June 18, 2019

Europe has been urged to extend the grandfathering period for medical devices to avert the threat to patients.

Canada joins textured breast implants ban over cancer links
Douglas Dalby · May 29, 2019

Canada has become the latest country to halt the sale of textured breast implants linked to an increased risk of rare cancer,…

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.