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.
A new study in a leading plastic surgery journal offers more evidence to support the existence of breast implant illness.
US health authorities have issued a warning letter to leading global manufacturer, Allergan, for failing to properly carry post-market safety studies.
ICIJ received more than 3,500 responses from people affected by the medical device industry in 50 countries, bringing to life the personal cost of implants that fail.
U.S. health authorities have recommended that breast implant manufacturers provide stronger patient safety warnings.
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.
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.
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.
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.
There is growing international concern over breast implant safety, particularly due to a rare cancer that occurs most often in implants with rough surfaces.
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.
Since we published our first stories, regulators have vowed to fix gaps in medical device oversight. But some promises have not been backed up by action.
A committee convened by France’s medical device safety authority has stopped short of calling for the total removal of textured breast implants.
Investors have filed a class action lawsuit against breast implant manufacturer Allergan, alleging the company concealed the association between textured breast implants and a rare form of cancer.
A specific type of Allergan breast implant that has been linked to an emerging form of cancer has been recalled in Europe, French authorities announced on Tuesday.
Manufacturers fought to get implants back on the market. Regulators gave in. Now thousands of patients are paying the price.