|November 8, 2010. InfoDesk|
|By Amy Norton NEW YORK (Reuters Health) – Women who have breast reconstruction after cancer surgery tend to be happier with the cosmetic results of silicone implants than with saline-filled ones, a study published Monday suggests. Silicone breast implants have had a troubled history. In 1992, the U.S. put limits on their use, over concerns that the devices could leak and potentially contribute to cancer or autoimmune disorders such as lupus and rheumatoid arthritis. But studies since then, including a report from the Institute of Medicine, an advisory panel to the U.S. government, have concluded that there is no clear link between silicone implants and those diseases. In 2006, the Food and Drug Administration (FDA) approved widespread use of two brands of silicone gel-filled implants for breast reconstruction and cosmetic breast augmentation. Surgeons have long held that silicone implants produce better cosmetic results than saline-filled varieties. But it has not been clear what patients think, said Dr. Colleen M. McCarthy, a surgeon at Memorial Sloan-Kettering Cancer Center in New York and the lead researcher on the new study. For their study, McCarthy and her colleagues surveyed 672 women who had undergone breast reconstruction after a mastectomy (removal of the breast) at one of three U.S. and Canadian medical centers in the previous one to eight years. Of the 482 women who completed the study, 306 had received saline implants and 176 silicone implants. Overall, the researchers found, women with silicone implants had higher scores on a questionnaire designed to gauge patients’ satisfaction with the look and feel of their breasts after breast surgery. The difference in scores did not indicate that women were unhappy with saline implants, McCarthy said. “These women were still very satisfied with saline implants,” she told Reuters Health. However, she also pointed out that the difference in satisfaction between the saline and silicone groups was similar in magnitude to the difference between women who had received radiation therapy for their cancer and those who had not. Women who’d received radiation tended to be less satisfied with their breast reconstruction — which, McCarthy noted, is not surprising, as radiation patients generally have a higher rate of implant-related complications like capsular contracture, in which scar tissue forms and compresses the implant and breast tissue into a hard, unnatural shape. The bottom line for women facing breast reconstruction, according to McCarthy, is that “it’s likely that they’ll like the look and feel of silicone implants better.” However, the decision on reconstruction is a personal one. First, McCarthy noted, women and their surgeons need to discuss whether an implant will be used at all; reconstruction can also be done using tissue from elsewhere in the body, such as the abdomen — though this is a more extensive and complex procedure than implant-based reconstruction. Once a woman decides to go with an implant, then the question is whether she is comfortable with the idea of a silicone implant, McCarthy said. Silicone implants can cost twice as much as saline implants, a difference of about $1,000 per implant. There are no known significant differences between saline and silicone implants in risks of complications like capsular contracture, breast pain and changes in nipple or breast sensation, according to McCarthy. The main difference, she said, is that, if the implant does rupture, it will be obvious with a saline-filled one because the implant will quickly “flatten.” The implant shell can then be removed and replaced; there is no known health risk from the leaking saline solution. With silicone implants, a rupture in the shell will more often than not be unnoticeable because the device does not “deflate,” though the gel can leak into the space surrounding the implant. While evidence suggests that the leaking gel is not connected to serious disease risks, it may eventually lead to scar tissue buildup and pain in the breast. Because silicone-implant ruptures are usually “silent,” the FDA recommends that women have an MRI every two years, beginning three years after surgery, to detect any ruptures, McCarthy pointed out. So women need to consider that need for repeat MRIs, which may not be covered by insurance, in deciding on an implant type. In addition, the long-term safety of silicone implants is still under scrutiny. In approving the two silicone implants currently on the market, the FDA required that the device makers — Allergan and Mentor — conduct a 10-year post-approval study of about 40,000 silicone-implant recipients to track complication rates and patients’ compliance with the MRI recommendations. McCarthy said that further innovation in breast implants is still needed. One device now under study is a so-called “gummy bear” implant, a so-called cohesive silicone-gel implant designed to be more resistant to leaks should the shell rupture. None of the researchers on the current study report any financial conflicts of interest. SOURCE: http://link.reuters.com/zeg44q Cancer, online November 8, 2010.
Categories: Allergan, Breast Aesthetics, ETHICON, MENTOR, Plastic Surgery