Houston, Texas, USA : 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 per cent higher compared to women without implants,” said Jan Willem Cohen Tervaert, director of the Division of Rheumatology at the University of Alberta.
“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 exists 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 U.S. Food and Drug Administration, said Cohen Tervaert.
“The U.S. health regulators say they’ll 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.
“Bottom line, there is clear evidence that implantation of foreign bodies in humans is not without risks in patients who are genetically predisposed to an autoimmune disorder. This 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 hernia or gynecological repair, may be the reason so many patients report symptoms of an autoimmune disorder. Specifically, he found that 45 per cent of patients developed an autoimmune disorder such as lupus or rheumatoid arthritis after a mesh implantation, and patients who had allergies before the implant were significantly worse after.
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’s 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, fatigues and may become dysfunctional,” explained Cohen Tervaert.
Concerned patients should discuss risks with their physicians about existing or future breast or mesh implants, he said.
The United Kingdom, Scotland, Australia and New Zealand have already put holds on mesh implantation, said Cohen Tervaert.
“In addition, patients in the Netherlands who are planning a breast implant are warned about the increased risks of developing autoimmune disorders if they already have allergies. In Canada, there are no rules (yet) in place.”
Citation: Abdulla Watad et al. Silicone breast implants and the risk of autoimmune/rheumatic disorders: a real-world analysis, International Journal of Epidemiology. DOI: 10.1093/ije/dyy217
A second study found that breast implants slightly increase risk of breast ALCL
Breast implants slightly increase risk of breast ALCL
Breast implants are associated with an increased risk of anaplastic large-cell lymphoma in the breast (breast-ALCL), though the absolute risk is small, according to a study published in JAMA Oncology.
Mintsje de Boer, M.D., from the Maastricht University Medical Centre in the Netherlands, and colleagues used data from the nationwide Dutch pathology registry to identify all patients diagnosed with primary non-Hodgkin lymphoma in the breast between 1990 and 2016. In addition, clinical data, including breast implant status, were obtained from treating physicians. The authors used a case-control design to compare implant prevalence between women with breast-ALCL and those with other types of breast lymphoma.
The researchers found that 32 of the 43 patients with breast-ALCL (median age, 59 years) had ipsilateral breast implants, compared with one case among 146 women with other primary breast lymphomas (odds ratio, 421.8). Among breast-ALCL cases, implants were more often macrotextured (23 macrotextured of 28 total implants of known type; 82 percent) compared to what might be expected based on sales data (45 percent). The cumulative risks of breast-ALCL in women with implants were 29 per million at 50 years old and 82 per million at 70 years old. To cause one breast-ALCL case before age 75 years, the number of women with implants needed was 6,920.
“Our results emphasize the need for increased awareness among the public, medical professionals, and regulatory bodies; promotion of alternative cosmetic procedures; and alertness to signs and symptoms of breast-ALCL in women with implants,” the authors write.
A third study dound that a rRare cancer linked with textured breast implants may be underreported and misunderstood
Rare cancer linked with textured breast implants may be underreported, misunderstood
A rare cancer in patients with breast implants may be on the rise, but not all patients and physicians may be aware of the risks associated with the procedure, according to a group of Penn State College of Medicine researchers.
Breast implant-associated anaplastic large cell lymphoma—or BIA-ALCL—is a rare peripheral T-cell lymphoma that may develop in patients with breast implants. The researchers said the cancer is likely underreported, and although it appears to be linked with a certain type of implant, more research is needed to identify the specific cause.
In a new literature review, the researchers analyzed 115 research articles in which 95 patients were evaluated to learn more about the development, risk factors, diagnosis and treatment of BIA-ALCL. The results were published in a research review today (October 18) in JAMA Surgery.
“We’re seeing that this cancer is likely very underreported, and as more information on this type of cancer comes to light, the number of cases is likely to increase in the coming years,” said Dino Ravnic, assistant professor of surgery, Penn State College of Medicine. “We’re still exploring the exact causes, but according to current knowledge, this cancer only really started to appear after textured implants came on the market in the 1990s.”
BIA-ALCL is estimated to affect 1 in 30,000 women with breast implants each year, although the researchers said the cancer could be more common. The researchers said almost all of those cases were associated with textured implants, which have a slightly rough surface that keeps the implant in the correct position.
Textured implants rose in popularity in the 1990s, and the first case of BIA-ALCL was documented in 1997. The researchers say that because they could find no incidents of BIA-ALCL prior to the introduction of textured implants, this suggests a causal relationship, although more research is needed.
“All manufacturers of textured implants have had cases linked to this type of lymphoma, and we haven’t seen cases linked to smooth implants,” Ravnic said. “But in many of these cases the implant was removed without testing the surrounding fluid and tissue for lymphoma cells, so it’s difficult to definitively correlate the two.”
After reviewing the literature, the researchers believe that BIA-ALCL may occur as a result of inflammation surrounding the breast implant, and tissue that grows into the tiny holes in the textured implant may prolong that inflammation. Previous research has shown that chronic inflammation can lead to lymphoma.
In the cases analyzed, BIA-ALCL typically developed slowly, with good prognoses for patients who had both the implant and surrounding scar tissue removed. Of the 95 patients in the review, five died.
The researchers recommend that in the future, surgeons should communicate the risks of BIA-ALCL to patients. Physicians should also stress the importance of routine checkups after the implants are in place.
A fourth study found that surgical mesh implants may cause autoimmune disorders
Surgical mesh implants may cause autoimmune disorders
Surgical mesh implants, often used for hernia or gynecological repair, may be the reason so many patients report symptoms of an autoimmune disorder, according to a University of Alberta rheumatologist.
“In my practice, I studied 40 patients who had mesh implants and found that almost all of them had symptoms such as chronic fatigue, cognitive impairment known as “brain fog,” muscle and joint pain “fibromyalgia,” feverish temperature, and dry eyes and dry mouth,” said Jan Willem Cohen Tervaert, director of the Division of Rheumatology at the U of A.
“Of those patients, 45 per cent developed an autoimmune disorder such as lupus or rheumatoid arthritis. And in the patients who had allergies before the implant, they were significantly worse after.”
Cohen Tervaert presented his study results at the 11th International Conference on Autoimmunity in Lisbon in May 2018, and will soon publish them in a leading journal.
“My study is small; however, it is beyond coincidence that these symptoms, which often go untreated or even unacknowledged by some doctors, exist among so many mesh implant patients. A larger study is needed to confirm whether in fact the implanted mesh is to blame,” he added.
Cohen Tervaert theorized that the causal link could be the same one found to be true in silicone breast implant disease.
“When a foreign body is put into the body, there is an instant activation of the immune system. It continues to fight the foreign body and eventually, over time, fatigues and becomes dysfunctional,” he said.
“Large-scale studies have shown that patients with breast implants have more symptoms of ASIA (autoimmune/autoinflammatory syndrome induced by adjuvants) and an increased risk to develop an autoimmune disorder. And in animal models, it has been demonstrated that these silicones can induce autoimmune diseases if the animals have the right genetics.”
What concerned patients need to know
Cohen Tervaert said there is no need for patients with mesh implants to panic.
“Many patients do not develop symptoms or a disease. You must have the genes in the first place.”
Concerned patients should discuss risks with their physicians about existing or future mesh implants. One guiding rule of thumb could be whether or not a patient has pre-existing allergies, added Cohen Tervaert.
He noted that pre-existing allergies were present in 80 per cent of breast implant patients—the same percentage who had allergies when mesh implantation caused problems in his patient group.
“In the Netherlands, the government informed all plastic surgeons that if patients who consider breast implants have pre-existing allergies, they should consider not doing the surgery at all. At the very least, we should be warning patients with allergies that their symptoms may worsen after a mesh is put in.”
He added, “It is my dream that in the future, we have a genetic test that can inform people who are vulnerable to develop autoimmune disorders after implants, but unfortunately we are not there yet.”
There is also hope for patients with mesh implants who do have autoimmune symptoms after the mesh is removed, said Cohen Tervaert.
“Patients who have had symptoms associated with breast implants felt much better after the implants were removed, and in some cases they reported a total cure.”