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After assurance from breast implant makers that concerns about silicone leaks were a thing of the past, more than 10 million women worldwide have received silicone breast implants in the past decade. However, a growing body of research — supported by increased symptom reporting by women —links silicone breast implants to autoimmune disorders and a rare form of immune cancer.

Silicone breast implants linked to autoimmune disease

Doctors commonly advise potential breast implant candidates that the risks are minimal, yet multiple recent studies indicate otherwise.

A recent study at the University of Alberta comparing nearly 25,000 women with breast implants to nearly 100,000 without them confirmed that nearly one in four implant recipients is at risk of developing an autoimmune disorder.

The risk for women with breast implants developing an autoimmune disease is 45 percent higher than for those without implants.

While former studies on the topic have been criticized because they were based on self-reporting by subjects, this study used doctor-based diagnoses to confirm results.

Previous research has also found surgical mesh implants used for gynecological or hernia repair may be linked to autoimmune disorders such as rheumatoid arthritis and lupus. Additionally, patients with allergies prior to the procedure were significantly worse afterward.

In the Alberta study, the strongest links were shown between silicone implants and these autoimmune conditions:

• Sjögren’s syndrome, an autoimmune disorder of the salivary and tear glands.
• Sarcoidosis, an autoimmune disorder of the lung, skin and lymph nodes.
• Systemic sclerosis, an autoimmune disorder of the connective tissue affecting the skin, arteries, and visceral organs such as lungs and kidneys.

The theory behind these findings is that foreign material of the mesh and silicone implants causes an activation of the immune system. The body continues to fight the “invader” and over time autoimmunity develops.

In the largest-ever long-term safety study of breast implants, a similar study this year at The University of Texas MD Anderson Cancer Center linked silicone implants with higher rates of Sjögren’s syndrome, rheumatoid arthritis, scleroderma, dermatomyositis, and melanoma compared to the general population.

Emerging form of breast implant-related cancer on the rise

Individuals with breast implants are also at risk of developing breast implant large cell lymphoma, or BIA-ALCL. BIA-ALCL is not breast cancer but a form of non-Hodgkin’s lymphoma, a cancer of the immune system.

In most cases BIA-ALCL is found in fluid and scar tissue near the implant, however there are cases where it spreads throughout the body.

The FDA states, “At this time, most data suggest that BIA-ALCL occurs more frequently following implantation of breast implants with textured surfaces rather than those with smooth surfaces.”

Plastic surgeons have identified 615 cases of BIA-ALCL worldwide with the disease occurring at higher rates among women with textured implants. French authorities have recommended against the use of textured implants due to the cancer risk.

At present, however, the risks are difficult to determine due to significant limitations in world-wide reporting and lack of data.

Lax reporting rules at fault for lack of patient awareness

Prior to 2017 the FDA allowed breast implant companies to report breast implant injuries as routine events that did not require public disclosure. This effectively kept the information from the public and may have skewed opinions on the safety of using them.

In 2017 reporting rules were changed and reports of injuries soared. At the current rate, they are slated to increase more than 20-fold in the last two years from the previous two-year period.

According to an ICIJ analysis of FDA data, after the rule change the number of suspected breast implant injuries skyrocketed from 200 a year to more than 4,500 in 2017 alone.

In just the first half of 2018, that number almost doubled to more than 8,000 filed reports.

The increase in reports doesn’t mean implants are suddenly going bad but that they may never have been as safe as patients were told in the first place.

The FDA has acknowledged a “transparency issue” regarding the undisclosed injury reports and that the increase in numbers reflected the change in reporting rules.

Changing the system to better protect breast implant recipients

The FDA warns that as many as one in five women who receive breast implants will get them removed within a decade due to complications such as rupture, deflation, and painful contraction of scar tissue around the implant, but currently there is no warning about autoimmunity.

The good news is that in response to the new information, the FDA and agencies around the world acknowledge that more research needs to be done to determine the autoimmune and cancer risks of implants.

While current studies do not prove breast implants cause these diseases, they do show that women with the implants suffer them at significantly higher rates than women without implants.

It’s proposed that bacterial infection of a biofilm that surrounds the implants is the likely cause of implant-related illness, including BIA-ALCL.

Patient advocates propose rules requiring breast implants to be sold with “black box” label warnings, which are reserved for life-threatening and other serious risks.

Undoubtedly, it will take much larger and longer studies to root out the details and bring about protective actions, and in the meantime doctors and patients need to have deeper conversations about the benefits and risks of silicone breast implants.