Pip breast implants unsafe, say german authorities


Pip breast implants unsafe, say german authorities

German authorities at the BfArM Institute have officially informed the International Society for Aesthetic Plastic Surgery (ISAPS) that the former GfE Medizintechnik GmbH in Germany sold breast implants under the name TiBREEZE from September 2003 to August 2004, which were manufactured with PIP components.

GfE Medizintechnik GmbH was coating silicone implants with a titanium layer and sending them to PIP in France to be filled with their silicone gel, which consisted of the same composition of industrial grade silicone that PIP and Rofil implants were filled with since 2001. The German authorities at the BfArM Institute therefore amended the recommendation to remove PIP and Rofil implants they made earlier this month to also include TiBREEZE implants as a measure of precaution, even in the absence of any symptoms.

GfE's company successor informed ISAPS that 728 implants were produced during the period of the former company's affiliation with PIP. The majority of TiBREEZE implants were sold and used in 280 patients in Germany. Other countries that bought the implants include Austria, Belgium, England, Finland, Italy, Lichtenstein, Switzerland and South Africa. It is thought that a total of 400 patients are affected.

Dr. Dirk Richter (Germany), Chair of ISAPS' Patient Safety Committee declared:

"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 International Society of Aesthetic Plastic Surgery is the largest international society of individual board certified, or equivalent aesthetic plastic surgeons. It was founded forty-one years ago and counts 2,140 members in 93 countries. To join the society, surgeons must undergo a strict application process to determine their qualifications. ISAPS mission is to continue educating plastic surgeons in the latest techniques in the field of aesthetic plastic surgery and medicine and to promote patient safety.

All ISAPS members are listed on the website.

Germany urged women to remove PIP breast implants (Video Medical And Professional 2020).

Section Issues On Medicine: Women health