Defective silicone aids
It was announced the Federal Institute of Medicines and Medical Devices (BfArM) that from the previous company GfE Medizintechnik GmbH has also marketed implants (under the name TiBREEZE brand), in the manufacture of defective silicone gel manufactured by the French company PIP (Poly Implant Prothèse) were used in. PIP silicone implants were used in 2010 with around 500,000 women worldwide.
First known defects since 2000
It is said that the first defects in the form of implant rupture were known in the PIP in 2000. However, the authorities were not activated until ten years later, specifically in the spring of 2010, and trade in the plantation was prohibited . However, for a long time the health risks were not or were not minimized, so the women affected in recent weeks, even from the official side, certainly suggested that the implants be removed or that they have been replaced.
The low quality of the silicon crop (cheap industrial silicon instead of medical silicon) has not been recognized by the responsible TÜV, which means that this will be justified in early Kara Keto February in the courts.
Cheap silicone can cause painful inflammation
Cheap silicone in breast implants can cause silicone gel to leak and cause painful swelling. In addition, since some women are now breast implants with implants, research is being conducted on whether there is a causal relationship with PIP implants.
The German company sold PIP implants
So far, it has been noticed that the PIP and Rofil implants have been warned. Now it turns out that the previous company GfE Medizintechnik GmbH distributed PIP implants for one year (September 2003 to August 2004). The silicone implants were manufactured by GfE Medizintechnik GmbH using a titanium alloy and then packaged by PIP in France using its own silicon generation. In total, 728 TiBREEZE were produced. Most of the samples were sold in Germany, where 280 women were affected. However, TiBREEZE is also grown in Belgium, Italy, Finland, South Africa, England, Austria, Liechtenstein and Switzerland. It is estimated that a total of 400 people around the world can be affected.
It is also recommended to replace the implant without symptoms
For this reason, BfArM today extended its recommendation on January 6, 2012 to eliminate PIP and Rofil implants, as well as TiBREEZE implants. This should be seen as a precautionary measure and should also be done by those who cultivate them who (still) have no symptoms. The transplant will be covered by health insurance companies if the implants are used as a result of breast cancer. However, for breast enlargement, which is only done for beauty reasons, it is expected to be exchanged for lack of payment in cash.
However, now it is not only about the cost of implant removal, but also the fact that complications have probably already occurred, which in the end also want to be treated and paid for.
There are no safety studies with silicone
According to Dr. Dirk Richter, Chairman of the ISAPS Committee patient safety * (International Society of Plastic Surgery = International Society of Plastic Surgery), it is also compatible with his recommendations of the German and French authorities that all women with TiBREEZE – They must implant breasts of PIP or Rofil products after 2001, visited a specialist plastic surgeon And discuss the elimination of plantations. Finally, “there are still no studies to demonstrate the safety of silicon in the human body.”
Meanwhile, Jean-Claude Mas, the founder of PIP, filed for bankruptcy in 2010 and took his money safely on time. He now lives in a villa in southern France, while his insurance was forced to cover claims previously filed by women. Injured
The International Society of Plastic Surgery (ICA) was founded 41 years ago, is the largest certified surgeons association in the world and has 2,140 members in 93 countries. Surgeons must undergo a rigorous admission procedure before becoming a member of ISAFS. The main objectives of the organization include the continuing education of its members in the latest techniques and procedures in plastic surgery and general practice, as well as the improvement of patient safety in general. A list of ISAPS members can be found at www.isaps.org.