HANOVER, N.H., Jan. 29, 2012 /PRNewswire-Asia/ -- 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."
The forty-one year old International Society of Aesthetic Plastic
Surgery is the largest international society of individual board
certified (or the equivalent) aesthetic plastic surgeons with 2,140
members in 93 countries. Surgeons undergo a strict application
process to determine their qualifications to join the society. The
ISAPS mission is twofold: the continuing education of plastic
surgeons in latest techniques in the field of aesthetic plastic
surgery and medicine and the promotion of patient safety. All ISAPS
members are listed on the website www.isaps.org
SOURCE﹛International Society for Aesthetic Plastic Surgery
(ISAPS)