Intracapsular rupture – can happen with capsule created by the body to wall off (silicone implant) foreign object. Implants do not last a lifetime. When saline breast implants break, they often shrink quickly and can be easily removed. However, when silicone implants break they rarely shrink and the silicone from the implant can leak and transfer outside of the scar tissue that the body creates around the implant. It is known as "extracapsular silicone", which can drift to other parts of the body. Extracapsular silicone can provoke granulomas (inflammatory nodules) and axillary lymphadenopathy. The health risks of implant rupture are not known, but the cosmetic risks are clear, with some women losing significant breast tissue when the silicone has leaked. The potential risk of silicone migration is still controversial.
The FDA states on their website that rupture is a concern because: 1. Rupture of silicone gel-filled implants may allow silicone to migrate through the tissues to the lymph nodes and from there to organs such as the lungs, where it can't be removed. 2. The health effects of leaking silicone is unknown. 3. Implant rupture is a device failure - the implant is no longer performing as intended. In 2001 FDA study reported a significant increase in fibromyalgia and several other connective tissue diseases among women with extracapsular leakage, compared to women whose implants were not broken or leaking outside the capsule. In a 2004 article in Journal of Autoimmunity, scientists reported patients with implants demonstrated statistically significant elevation in anti-silicone antibodies compared with the unimplanted control groups. The highest anti-silicone antibody levels were measured in implanted women with either implant ruptures or leakage of their silicone gel implants. The age of the implant is an important factor in fracture. The FDA rupture study was greater to previous rupture studies because it was confined to women who had silicone gel implants for at least 6 years and had not removed their implants or informed problems with them. Based on magnetic resonance imaging (MRI) they found that 77% of the women had at least one ruptured implant, even though most had no symptoms and were ignorant of the leakage. Neither of the two US implant manufacturers has collected MRI data on rupture or leakage for women implants for more than 3-4 years. Therefore, it is impossible to determine if the implants that those companies currently sell have a different rupture rate or likelihood of leakage compared to the implants in the FDA study, which included Mentor and Inamed implants as well as implants made by other companies. Since the research indicates that most ruptures of silicone gel implants are "silent," with no symptoms, the FDA recommends MRIs as the gold standard for distinguishing rupture. The FDA General and Plastic Surgery Advisory Panel has considered recommending annual MRIs, but determined that the cost would be unaffordable for screening purposes. However, manufacturer data provided on the FDA website clearly indicate that clinical exams are insufficient to rule out suspected rupture.
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