Silicone gel filled breast implants 를 위한 안전성 경고 / 현장 안전성 서한

Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and the United Kingdom.

In March 2010 the MHRA was informed by the French regulatory authorities (AFSSAPS) that most PIP silicone gel breast implants manufactured from January 2001 were filled with an unapproved silicone gel material. The MHRA’s advice for the management of women implanted with PIP silicone gel breast implants after 1 January 2001 was given in MDA/2010/078, published in October 2010.Updated information from AFSSAPS suggests that there is no guarantee that PIP silicone gel breast implants manufactured prior to 2001 contained the approved filler. Therefore, all women implanted with PIP silicone gel breast implants should be supported and managed in line with the Department of Health’s recommendations of January 2012.Information recently received from the UK supplier of PIP breast implants suggests that up to 7,000 women may have received PIP silicone gel breast implants prior to January 2001. This is in addition to the approximately 40,000 women previously believed to have received affected implants after 1 January 2001.