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.

Clinical management of women implanted with PIP silicone gel filled implants.On Tuesday 30 March 2010, the French medical device regulatory authority (AFSSAPS) informed the MHRA that it had suspended the marketing, distribution, export and the use of silicone gel filled breast implants manufactured by PIP (a French breast implant manufacturer). AFSSAPS recalled all of these devices. The MHRA issued MDA/2010/025 on 31 March 2010 advising UK clinicians not to implant these devices.AFSSAPS had carried out an inspection of the PIP manufacturing plant and established that breast implants manufactured by the company since 2001 had been filled with a silicone gel with a composition different from that approved.AFSSAPS has carried out testing of affected implants to look at the genotoxicity (potential for cancer), chemical toxicity of the filler material and mechanical properties of the implant shell. The MHRA also commissioned tests to look at genotoxicity and chemical toxicity.Test results have not shown any evidence of genotoxicity or chemical toxicity of the filler material. One of the French genotoxicity tests was, however, inconclusive and further testing will be conducted by AFSSAPS with results expected in early 2011.Mechanical testing of the implant shells carried out by AFSSAPS suggests that there may be an increased risk of rupture. However, the Therapeutic Goods Administration (TGA) of the Australian government also carried out tests on PIP silicone gel filled breast implants and found that these implants conformed to the relevant international standards for this type of product, including those for gel cytotoxicity and shell strength.