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.
US health authorities have issued a warning letter to leading global manufacturer, Allergan, for failing to properly carry post-market safety studies.
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.
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.