There are many hundreds of medical devices that are implanted in to patients in this day and age, from hip and knee joints, types of surgical mesh, pacemakers, artificial heart valves, biologic materials as well as breast implants to name just a few. The vast majority of patients implanted with these medical devices have no adverse reactions. The device works and performs as expected to treat medical conditions or help patients better manage their health. However, a growing body of evidence suggests that a small number of patients may have biological responses to certain types of materials in implantable or insertable devices. For example, they develop inflammatory reactions and tissue changes causing pain and other symptoms that may interfere with their quality of life.
Silicone implants have been used in tens of millions of women across the World since the first breast enlargement in 1962. Breast implants are some of the most regulated and investigated devices in the world. There have been large independent reviews that have looked at the safety of silicone implants. In particular the UK Independent Review Group (published in 1998) and the USA Institute of Medicine (IOM) Committee on the Safety of Silicone Breast Implants (published in 1999). Both reports found no link to autoimmune problems or breast cancer. They concluded that local complications were “the primary safety issue with silicone breast implants.” These local complications, which included rupture, pain, capsular contracture, disfigurement, and serious infection, lead to medical interventions and repeat surgeries. Importantly, the IOM report concluded that there was no evidence that silicone breast implants caused systemic health effects such as cancer or autoimmune disease. The National Science Panel concluded that silicone is of low toxicity and that the local reaction to silicone is similar to other foreign-body reactions.
In November 2006, the FDA approved Allergan’s Natrelle Silicone Gel-Filled Breast Implants and Mentor’s MemoryGel Silicone Gel-Filled Breast Implants. The FDA based its approvals on the manufacturers’ clinical studies, called Core Studies, which followed hundreds of women with silicone gel-filled breast implants for 3 (Mentor) or 4 (Allergan) years. The last FDA Update on the Safety of Silicone Gel-Filled Breast Implants was published in 2011. They identified that most infections develop in the immediate post-operative period, although infections can develop long after implant and may be underreported. The current body of literature did not support an association between connective tissue disorders and silicone gel-filled breast implants, but most of the available studies have limitations. Based on the totality of the evidence, the FDA believes that silicone gel-filled breast implants have a reasonable assurance of safety and effectiveness when used as labelled. Despite frequent local complications and adverse outcomes, the benefits and risks of breast implants are sufficiently well understood for women to make informed decisions about their use. Most women report high levels of satisfaction with their body image and the shape, feel and size of their implants.
Although existing data do not allow the definite exclusion of systemic or local immune responses associated with silicone breast implants, no valid scientific evidence currently establishes any such association. In fact, the nature of science is such that no scientific data can ever allow the definite and unexceptional exclusion of this possibility. Based on the evaluation of the FDA and discussions with experts elsewhere in the government and academia, we believe the current evidence, although limited, suggests some individuals may be predisposed to develop an immune/inflammatory reaction when exposed to select materials in implants in general (not just breast). The symptoms some patients experience may be limited to the region where the device is implanted or may be more generalized. Symptoms include but are not limited to fatigue, rash, joint and muscle pain or weakness. Although uncommon and varied, these symptoms may share common underlying immune/inflammatory pathways and mimic more well-established inflammatory conditions. In the small subsets of patients who have reported these symptoms, the symptoms may not develop for several years following implantation. As a result, they may not be detected even in larger and longer clinical studies. To date, these symptoms have not been reported with most materials used in medical devices, including most metals. Moreover, when reported, they have tended to be limited to small subsets of patients. As an example, some patients, mostly with a history of pre-existing allergies, may develop allergic skin lesions with certain device use. This risk is usually identified by patch testing for potential device material-related allergens. However, not all device-related reactions are allergic in nature.
Some patients have reported to the FDA concerns that their breast implants may be connected to other health conditions that could be associated with their immune system’s response to these devices, resulting in symptoms like chronic fatigue, cognitive issues and muscle pain (like a breast implant illness). While the FDA doesn’t have definitive evidence suggesting breast implants are associated with these conditions, they are looking to gain a fuller understanding of this issue to communicate risk, minimize harm and help in the treatment of affected patients. Mt own view is that we can’t 100% exclude the possibility that implants make some patients ill or might set off an autoimmune disorder, and even though I have never personally seen this is any of may augmented or reconstructed patients in over 15 years, if a patient was to get such symptoms they may have to accept that implants are simply not for them and have them removed as a precaution. Mentor explore safety data further on their web page on implant safety: http://www.mentorwwllc.com/global-us/SafetyInformation.aspx