The International Society for Aesthetic Plastic Surgery (ISAPS) has been officially informed by the German authorities at the BfArM Institute that the former company, GfE Medizintechnik GmbH in Germany, sold implants that were manufactured using PIP components. From September 2003 to August 2004 they were sold under the name TiBREEZE. These silicone implants were coated by GfE Medizintechnik GmbH with a titanium layer and subsequently filled by PIP in France with their silicone gel. The silicone composition was the same as in PIP and Rofil implants that were filled with industrial grade silicone since 2001. Therefore, the German authorities at the BfArM Institute today amended their recommendation of 6 January 2012 to explant PIP and Rofil implants to include explantation of TiBREEZE implants as a precautionary measure even without symptoms.
The successor of the company stated to ISAPS that 728 implants were produced in this period of time. Most of those implants were sold in Germany where they include about 280 patients. In addition to Germany, TiBREEZE implants were delivered to the following countries: Belgium, Italy, Finland, South Africa, Switzerland, England, Austria and Lichtenstein. A total of 400 patients worldwide are thought to be affected.
According to Dr. Dirk Richter (Germany), Chair of ISAPS' Patient Safety Committee, "as there are no studies yet available to prove the safety of industrial grade silicone in the human body, ISAPS supports the French and German authorities' recommendations and encourages all women with TiBREEZE, PIP or Rofil breast implants produced after 2001, to check with a specialized plastic surgeon to discuss removal of the implants."
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