Breast Reconstruction and Saline Implants

Breast Reconstruction - Most Common Risks

Rupture

For breast reconstruction, 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/cdrh/breastimplants/studies/biinterview.pdf and http://www.fda.gov/cdrh /breastimplants/studies/biruptere.pdf.

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.

Capsular Contracture

The scar tissue or capsule that normally forms around the breast implant may tighten and squeeze the breast implant. This is called capsular contracture. Over several months to years, some women have had changes in breast shape, hardness, or pain as a result of this contraction. Although this seems to occur to some extent in most women with breast implants, there are no reliable data on how often this happens. If these conditions are severe, more surgery may be needed to correct or remove the breast implants.

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.