Roughened breast implants of the pharmaceutical company Allergan shall not be used in Europe for the time being. Implants with a rough so-called Biocell surface, are affected by French authorities. They are suspected to favor a very rare form of cancer called anaplastic large cell lymphoma (ALCL).
Remove the already inserted implants of this type is currently not recommended, if no symptoms occur. The risk for complications during surgery is much higher than the risk of developing long term, in the form of cancer.
The first known case of ALCL associated with a breast implant made of silicone has been documented in 1997. The disease is extremely rare. So far, worldwide, only a few Hundred cases have been documented, mostly in connection with rough implants, and the now withdrawn from the market product.
A study from the year 2015, according to a patient of up to three million women with breast implants is affected. It is, however, only estimates. Reliable calculations are hardly possible, since the number of documented cases is not collected centrally. In Germany have been reported, according to the Federal Institute for drugs and medical devices (Bfarm), ten suspected cases of ALCL associated with a breast implant.
No Breast Cancer
When the disease is not breast cancer, but a cancer of the cells of the immune system. Most of the lymphomas arose in scar tissue and in the fluid around the implant. In some cases, they had spread however in the whole body.
How long it took for the lymphoma developed after the breast SURGERY, fluctuated considerably. In some women, the tumors were discovered a year after the Implantation for more than 20 years. In General, the type of cancer is good to deal with. The mortality rate is under ten percent.
Why the rare Tumor occurs in the case of these implants is still unclear. “This must be stressed, that breast implants lead to an increased risk of breast cancer,” says physician Dennis from the home castle, President of the Association of German Aesthetic-Plastic surgeons (VDÄPC).
Breast implants are considered medical devices and must be certified in the EU with the CE mark, which must be renewed every five years. Because of the uncertain state of research the approval for Allergan has not been extended and implants now. The Irish pharmaceutical group had the implants in France to certify, therefore, the local national authority was a first for medicinal products safety ANSM is responsible. The CE marking applies throughout the EU.
In comparison to medications for the authorisation of medical products is easy. The manufacturer Poly Implant Prothèse (PIP) could, for example,. breast implants on the market locks, which were filled with industrial silicone The Scam was busted in 2010. Since then, the approval of medical products was more difficult, but still there are significant weaknesses.
Instead of one authority, Notified Bodies check the products and enter the market freely. The Problem is that These Bodies are of the orders of the manufacturer-dependent, because they are paid by you. Furthermore, companies can choose a licensing body. Read more about it here.
The manufacturer of the roughened implants, Allergan announced that it plans to cooperate fully with the authorities, but wants to go against the decision of the French authorities in appeal and ensure that the CE marking is extended. How many implants are affected and how often they were used, is unclear. Such information is not collected centrally.
No uniform Standards
In Germany, patients receive per year, about 65,000 breast implants, estimates the German society of Plastic, Reconstructive and Aesthetic surgeons (DGPRÄC). About 85 percent of which would have a roughened surface. The advantage is that The implants connect better with the surrounding connective tissue, causing them to slip less often. Thereby also the risk for painful callouses, so-called capsular fibrosis drops.
However, there are, according to the DGPRÄC no uniform Standards in the Definition of the surfaces. The process for the production of the rough surface varies from manufacturer to manufacturer.
“The case shows once again how important it is to capture all the implants, complete and binding manner,” says the plastic surgeon Riccardo Giunta. The DGPRÄC have been calling for for years, the establishment of a related database.
Insecure women, which may have been used one of the affected implants, can your doctor advise. Reason for great concern, however, is not, because the form of cancer is very rare. A ALCL is usually as a persistent swelling or pain in the vicinity of the breast implant is noticeable. In addition, fluids around, collect often around the implant. In some cases, thickened and conspicuous scars has been described in the tissue around the implant.
In General, women with breast should implants once in a year your doctor to check, regardless of whether they have complaints or not.