We agree that more needs to be done to protect people against unnecessary harm caused by silicone gel-filled breast implants. Implants have been on the market for more than 30 years, and during that time they’ve been used by millions of women, and yet, we still don’t know exactly what kind of problems they can cause, and how likely those problems are. This lack of knowledge is due to the FDA’s slow and weak regulation of breast implants, the manufacturers’ failure to do large long-term studies with careful follow-up, and the unwillingness of many surgeons to accept that implants make some people sick. We do know that many people who have health problems feel better after their implants are removed.
Implants were marketed for many years before Food and Drug Administration (FDA) had the legal authority to approve medical devices. It took an investigation by Congress and complaints by the NWHN and other women’s health groups to force the FDA to finally require manufacturers to study the devices. The NWHN took this action because we heard from many women that they believed their implants were making them sick. The FDA took implants off the market for several years and required studies. The FDA officially approved silicone breast implants in 2005, but even then the NWHN believed that approval was premature because adequate long-term studies of the devices had not been done. Many women who later report health problems feel fine during the first few years after getting breast implants, making long-term studies essential.
In 2011 the FDA raised concerns over a possible connection between breast implants and anaplastic large cell lymphoma (ALCL), which is not breast cancer but a type of T-cell lymphoma (cancer of the immune system). Because of gaps in implant sales data, it is difficult to determine the rate of breast implant-associated ALCL, but the FDA estimates that 1 in 3,817 to 30,000 recipients could be affected. This cancer has been found regardless of implant filling and texture, but people whose implants have a textured surface rather than a smooth surface are also more likely to experience these complications.
Breast implant recipients continue to report symptoms similar to those of autoimmune disorders including fatigue, muscle and joint aches, fevers, dry eyes and mouth, and occasionally poor memory or concentration. Although it is not technically a medical diagnosis, these symptoms are referred to as Breast Implant Illness (BII). Studies have now linked these symptoms to autoimmune syndrome induced by adjuvants (ASIA). This happens when materials, in this case the silicone used in breast implants, trigger an autoimmune response causing patients to display a variety of symptoms like the ones listed above. A 2013 study published in the Netherlands Journal Of Medicine found that most or all of the symptoms went away in 69 percent of women who had their implants removed. Another study published in the Journal of Rheumatology found that women whose silicone implants had ruptured and leaked into the surrounding tissues were more likely to be diagnosed with fibromyalgia, a disorder that has similar symptoms to BII. Although it is reassuring that many people feel better after having their implants removed, it would be more helpful if there were reliable estimates of how common these symptoms are over the long-term. The FDA is holding a public meeting on March 25 & 26 about the “benefit-risk profile” of implants. We will update our information after that meeting.
One thing people with implants can do to protect their health is to get MRIs to check for ruptures, if they can afford the test. Breast implant rupture is a tear or hole in the shell of an implant that releases the contents of the implant into the body. When a saline implant breaks, it is usually noticeable because the breast will appear deflated as the saline leaks out. When a silicone gel-filled implant ruptures, the silicone may be held in by the surrounding scar tissue and leak out gradually. These leaks are much more subtle and may require an MRI to detect. The FDA recommends people with silicone implants have an MRI every 2 years to check for a rupture. The leaking silicone can migrate to other parts of the body like the chest wall or armpit and become difficult or impossible to remove.
When testing the safety of their silicone breast implant products, the manufacturer Mentor specifically elected to exclude women with a family or personal history of autoimmune disease because they were more likely to display these negative symptoms. More research is required to fully understand the relationship between breast implants and autoimmune symptoms, especially in the long-term and in people with a history of autoimmune disease or silicone allergy. If you have experienced problems with breast implants you can submit your story to MedWatch, the FDA’s reporting system.
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