Roughened breast implants of the pharmaceutical company Allergan may not be used in Europe for the time being. Affected are implants with a rough so-called biocell surface, said French authorities. They are suspected of favoring a very rare form of cancer called anaplastic large cell lymphoma (ALCL).

Removal of existing implants of this type is currently not recommended if symptoms are not present. The risk of complications in the procedure is much higher than the risk of long-term cancer.

The first known case of ALCL in the context of a silicone breast implant was documented in 1997. The disease is extremely rare. So far, only a few hundred cases have been documented worldwide, mostly in connection with rough implants and the now taken off the market product.

According to a 2015 study, one patient in up to three million women is affected by breast implants. These are just estimates. Reliable extrapolations are hardly possible because the number of documented cases is not recorded centrally. According to the German Federal Institute for Drugs and Medical Devices (Bfarm), ten suspected cases of ALCL have been reported in Germany in connection with a breast implant.

No breast cancer

The disease is not breast cancer but a cancer of the cells of the immune system. Mostly, the lymphomas in the scar tissue and in the fluid around the implant around. In some cases, however, they had spread throughout the body.

How long it took for the lymphomas to develop after breast surgery varied considerably. In some women, the tumors were discovered as early as one year after implantation, others only after more than 20 years. Usually, the cancer is good to treat. The mortality rate is less than ten percent.

Why the rare tumor occurs in these implants is still unclear. "It must be emphasized that breast implants do not lead to an increased risk of breast cancer," says physician Dennis vom Heimburg, president of the Association of German Aesthetic Plastic Surgeons (VDÄPC).

Problematic implantsWhat patients need to know now

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 research situation, the approval for the Allergan implants has not been extended. The Irish pharmaceutical company had the implants certified in France, which is why it was also the local national authority for drug safety ANSM responsible. However, the CE marking is valid throughout the EU.

Compared to medicines, the approval of medical devices is easy. For example, the manufacturer Poly Implant Prothèse (PIP) was able to launch breast implants that were filled with industrial silicone. The scam flew in 2010. Since then, the approval of medical devices has been made more difficult, but there are still significant weaknesses.

Instead of an authority, "Notified Bodies" check the products and release them for the market. The problem: These jobs depend on the orders of the manufacturers because they pay for them. In addition, the corporations may choose a licensing office throughout Europe. Here you can read more about it.

The manufacturer of roughened implants Allergan announced that it would cooperate fully with the authorities, but wants to appeal against the decision of the French authorities and to ensure that the CE marking is nevertheless extended. How many implants are affected and how often they have been used is unclear. Such information is not collected centrally.

No uniform standards

In Germany, patients receive about 65,000 breast implants per year, estimates the German Society of Plastic, Reconstructive and Aesthetic Surgeons (DGPRÄC). About 85 percent of that would have a roughened surface. The advantage: The implants bond better with the surrounding connective tissue, which makes them less likely to slip. This also reduces the risk of painful hardening, called capsule fibrosis.

However, according to DGPRÄC, there are no uniform standards for the definition of surfaces. The methods for producing the rough surface vary from manufacturer to manufacturer.

"The case shows once again how important it is to capture all implants completely and bindingly," says Plastic Surgeon Riccardo Giunta. The DGPRÄC has been calling for years for the establishment of a binding database.

Insecure women who may have had one of the affected implants can get advice from their doctor. However, there is no cause for great concern, as the form of cancer is very rare. ALCL usually manifests as persistent swelling or pain around the breast implant. In addition, fluids often accumulate around the implant. In some cases, thickened and conspicuous scar tissue around the implant has also been described.

Generally, women with breast implants should have their doctor check them once a year, regardless of whether they have discomfort or not.