Women with breast implants mostly only had to worry about leaks, but a large-scale Israeli study performed in collaboration with researchers from the University of Alberta confirmed almost one in four implantation patients is at risk of a serious autoimmune disorder.
"The risk of women with breast implantation developing an autoimmune disease was 45% higher compared to women without implants," said Jan Willem Cohen Tervaert, director of the Division of Rheumatology at the U of A.
"While some previous studies have shown similar risks, their results were criticized because the diagnoses were self-reported, our study used a physician-based registration, so it's the first to confirm the relationship between implants and autoimmune disorders based on diagnoses made by doctors. "
The International Journal of Epidemiology study, which compared nearly 25,000 Israeli women with breast implants with nearly 100,000 women without an implant, will be discussed by the US Food and Drug Administration, said Cohen Tervaert.
Implants and autoimmune disorders
"The US health regulators say they will convene a public meeting of medical advisers next year to discuss new science on breast implant safety, including an independent analysis that suggests certain rare health problems might be more common with silicone gel implants," said Tervaert.
"Bottom line, there is evidence that implantation of foreign bodies in humans is genetically predisposed to an autoimmune disorder. Este is why screening measures, such as warning women who already have pre-existing autoimmune diseases or allergies of the increased risk, need to be put in place before surgery, "he added.
Previous research conducted by Cohen Tervaert showed that surgical mesh implants, often used for a hernia or gynecological repair, perhaps the reason for many patients reports symptoms of an autoimmune disorder.
"Specifically, I have found that 45% of patients developed an autoimmune disorder such as lupus or rheumatoid arthritis after implantation and patients who had allergies before the implant were significantly worse after," said Tervaert.
The new study also showed the strongest association between silicone breast implants and Sjögren's syndrome (autoimmune disorder of the salivary and tear glands), systemic sclerosis (autoimmune disorder of the connective tissue affecting the skin, arteries and visceral organs such as lungs and kidneys) and sarcoidosis (autoimmune disorder of the lung, skin and lymph nodes), said Cohen Tervaert.
The causal theory behind both breast and mesh implants and autoimmune disorders is that there is an instant activation of the body's immune system when a foreign material is put in it. "It continues to fight the foreign body and eventually, over time, fatigue and may become dysfunctional," explained Cohen Tervaert.