Are Breast Implants Safe in the Long Run?
The FDA has released a new report that breast implants are safe, but they are not safe enough to stay in for long.
In 2010, according to the report, there were a total of 296,203 breast augmentations in the U.S. In addition, there were 93, 083 breast reconstruction procedures in the U.S. About half these operations used implants filled with salt water (saline) and half were filled with silicone gel.
Currently, about 5-10 million women have breast implants around the world.
A new problem
The controversy on breast implants began in the early 1980s, when the FDA drew attention to published case reports that illustrated that breast implants caused cancer and connective tissue damage in some women. The FDA then demanded that implant manufacturers give the FDA more safety and research data.
The FDA wasn’t satisfied with the data. The FDA withdrew all silicone gel implants from the market in 1992, requiring applications with safety data before permitting back on to the market.
For the next fourteen years, silicone implants were practically unavailable. However, in 1999, the Institute of Medicine released a review of silicone breast implant studies. They concluded that silicone implants were safe, outside of what they called “local complications.”
What are “local complications?”
Those “local complications” included disfigurement, serious infections, pain, rupture, hardening and capsular contraction – the production of encapsulations around tissues that the immune system considers foreign. These are called “local” because much of these responses tend to occur within the region of the breasts.
The “local” region being referred to surrounds the breasts. This also happens to be a major junction region for the lymphatic vessels that drain toxins and infective agents from the head, neck and tissues surrounding the heart and lungs.
Other significant (greater than 1.7%) side effects reported for silicone implants have included rashes and hives, fatigue, arthritis and myalgia, swelling, chest pain and palpitations, numbness, disability, infection and breathing difficulties.
The FDA required further studies from manufacturers, the leading being Mentor and Allergan. Both produced several studies over the past decade showing a number of disturbing statistics. One Mentor study, for example, showed that 43% of women receiving saline implants experienced medical complications within three years of having their implantation. Of those, one out of ten had capsular contraption.
The studies have also found that one out five receiving breast implants for augmentation purposes had to remove them within ten years, for medical reasons, and one out of two women receiving implants for reconstruction had to remove them for medical reasons within ten years.
Those aren’t very good odds, when considering safety for the long run.
What about cancer and breast implants?
As for cancer, most of the research showed little or no association between breast implants and cancer. But should cancer be the only criteria for judging safety?
The FDA approved silicone breast implants in November of 2006 for reconstruction for all ages, and for augmentation for over the age of 22.
“Safety” in this case must be in the eye of the beholder.