Breast implants are not lifetime devices and cannot be expected to last forever. Some implants rupture in the first few months after being implanted and some rupture after several years, others are intact 10 or more years after the surgery.
When silicone gel-filled implants rupture, some women may notice decreased breast size, nodules (hard knots), uneven appearance of the breasts, pain or tenderness, tingling, swelling, numbness, burning, or changes in sensation. Other women may unknowingly experience a rupture without any symptoms (i.e., “silent rupture”). Magnetic resonance imaging (MRI) with equipment specifically designed for imaging the breast may be used for evaluating patients with suspected rupture or leakage of their silicone gel-filled implant.
Silicone gel, which escapes the fibrotic capsule surrounding the implant, may migrate away from the breast. The free silicone may cause lumps called granulomas to form in the breast or other tissues where the silicone has migrated, such as the chest wall, armpit, arm, or abdomen. Plastic surgeons usually recommend removal of the implant if it has ruptured, even if the silicone is still enclosed within the scar tissue capsule, because the silicone gel may eventually leak into surrounding tissues. If you are considering the removal of an implant and the implantation of another one, be sure to discuss the benefits and risks with your doctor.
FDA completed a retrospective study on rupture of silicone gel-filled breast implants. This study was performed in Birmingham, Alabama and included women who had their first breast implant before 1988. Women with silicone gel-filled breast implants had a MRI examination of their breasts to determine the status of their current breast implants. The 344 women who received a MRI examination had a total of 687 implants. Of the 687 implants in the study, at least two of the three study radiologists agreed that 378 implants were ruptured (55%). This means that 69% of the 344 women had at least one ruptured breast implant. Of the 344 women, 73 (21%) had extracapsular silicone gel in one or both breasts.
Factors that were associated with rupture included increasing age of the implant, the implant manufacturer, and submuscular rather than subglandular location of the implant. A summary of the findings of this study is also available on FDA’s website at http://www.fda.gov
Robinson et al. studied 300 women who had their implants for 1 to 25 years and had them removed for a variety of reasons. Visible signs of rupture in 51% of the women studied were found. Severe silicone leakage (silicone outside the implant without visible tears or holes) was seen in another 20%. Robinson et al. also noted that the chance of rupture increases as the implant ages. Other studies indicate that silicone may escape the capsule in 11-23% of rupture cases.
Making Breast Cancer Harder to Find
The breast implant could interfere with finding breast cancer during mammography. It may “hide” suspiciouslooking patches of tissue in the breast, making it difficult to interpret results. The breast implant may also make it difficult to perform mammography. Since the breast is squeezed during mammography, it is possible for a breast implant to rupture during the procedure. It is essential that every woman who has a breast implant tell her mammography technologist before the procedure. The technologist can use special techniques to minimize the possibility of rupture and to get the best possible views of the breast tissue. Because more x-ray views are necessary with these special techniques, women with breast implants will receive more radiation than women without breast implants who receive a normal exam. However, the benefit of the mammogram in finding cancer outweighs the risk of additional x-rays.
Other Known Risks
Calcium Deposits in the Tissue Around the Breast Implant
Calcium depositsmay form in the tissue around a breast implant and may cause pain and hardening of scar tissue. In some cases, these deposits may need to be surgically removed.
You should understand there is a fairly high chance you will need to have additional surgery at some point to replace or remove the breast implant. Also, problems such as rupture, capsular contracture, infection, shifting and calcium deposits can require removal of the breast implants. Discuss the risk of these additional surgeries with your physician. Many women decide to have the breast implants replaced, but some women do not.
Infection can occur with any surgery. The frequency of infection with breast implant surgery is not known, but as a prospective patient, you should ask your physician what his or her experience has been. Most infections resulting from surgery appear within a few days to weeks after the operation. However, infection is possible at any time after surgery. Infections with foreign bodies present (such as breast implants) are harder to treat than infections in normal body tissues. If an infection does not respond to antibiotics, the implant may have to be removed. After the infection is treated, a new breast implant can usually be put in.
A hematoma is a collection of blood inside the body (in this case, around the breast implant or around the incision). Swelling, pain, and bruising may result. The chance of getting a hematoma is not known, but if you are considering breast implants you should ask your physician about his or her experience. If a hematoma occurs, it will usually be soon after surgery. (It can also occur at any time after injury to the breast.) Small hematomas are absorbed by the body, but large ones may have to be drained surgically for proper healing. Surgical draining causes scarring, which is minimal in most women.
Delayed Wound Healing
In rare instances, the breast implant can stretch the skin abnormally, depriving it of blood supply and allowing the breast implant to push out through the skin. This complication usually requires additional surgery.
In addition to these known risks, there are unanswered questions about silicone-filled breast implants. For example, can the breast implants bring on symptoms of auto-immune diseases such as lupus, scleroderma, and rheumatoid arthritis? Can they bring on neurological symptoms similar to multiple sclerosis in some women? Can the breast implants increase the risk of cancer?
Connective Tissue and Related Disorders. These illnesses include autoimmune disorders such as lupus, scleroderma, and rheumatoid arthritis, as well as disorders such as fibromyalgia and chronic fatigue syndrome. Some women with breast implants have experienced these disorders as well as a variety of symptoms that could be related to the immune system. However, these symptoms may be present without breast implants or connective tissue disease. It is unclear at this time whether the signs and symptoms experienced by these women are related to their breast implants. In some cases, women have reported a reduction in symptoms after their breast implants were removed; in other cases, there was no change in symptoms after their breast implants were removed. Several human studies have been completed recently, which provide substantial, but not complete, information about any possible link between breast implants and immune-related disorders. These studies provide reassurance that the risk of developing a connective tissue disease due to breast implants is not high. Taken together, these studies tell us that the vast majority of women with breast implants will not develop defined immune-related disorders from their breast implants. Breast-Feeding and Children. At this time it is not known what effect breast implants have on lactation. Any breast surgery may impair breast feeding. A woman with breast implants who has questions about risks while pregnant or breast feeding should consult her physician. Cancer. At this time, there is no scientific evidence that women with silicone-filled breast implants are more susceptible to cancer than other women. Two large studies have shown no increase in the incidence of breast cancer in women with breast implants for either augmentation or reconstruction. However, the possibility has not been ruled out and further research is being conducted. Lifetime effects are currently unknown.