The latest breast implant scandal to hit Europe involves polyurethane foam-covered implants that have been sold in Europe for almost a decade, after being banned in the U.S. for over 20 years. While the PIP implant fears in Europe probably affect more women, the Silimed implant story may be even more frightening. Why did German regulators approve these types of breast implants, which were banned in 1991 because of evidence that the foam broke down into a known carcinogen in the woman’s breasts? The company says there is no evidence that their implants cause cancer, but cancer usually takes at least 15-20 years to develop. That’s why men and women who started smoking as teenagers almost never get diagnosed with lung cancer in their 20′s or 30′s.
Cancer is not the only risk of polyurethane foam. The body can have a very bad immune reaction to the polyurethane, and since the woman’s scar tissue grows into the foam, the implants can be almost impossible to remove. When these implants are taken out for any reason, it is not unusual for some of the woman’s own breast tissue to be removed as well, leaving her with smaller breasts than she had before breast implants. Her breasts may also be deformed from the explant surgery.
FDA can be proud that they did not allow Silimed or PIP breast implants to be sold in the U.S. in recent years. Unfortunately, all of Europe was forced to allow Silimed implants on the market after German regulators awarded the CE mark, which indicated they met European quality standards. How did this happen? It’s simple; Europe requires almost no evidence of safety for medical devices, not even for implants. These lower standards have hurt tens of thousands of women with breast implants, and millions of men and women with other types of implants that were not tested in clinical trials.
To learn more about the Silimed implant scandal, please read this article in the Daily Mail.