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Safety of Silicone Breast Implants

Kenneth S. McCarty

Since breast implants first came on the market 30 years ago, approximately one million women in the United States have had these devices surgically inserted for reconstruction following mastectomy or breast odification to enlarge or reshape their breasts. Most are filled with a silicone gel; however; about l0% contain saline (salt water). Until recently, both gel-filled and saline implants were available to virtually any woman who wanted them.The use of silicone gel-filled implants is controversial, and various opinions exist about who should be permitted to receive breast implants, what type should be used, and what purpose they should serve.

Q.What advice do you give to breast cancer patients regarding silicone gel-filled breast implants? What factors influence your advice to these women (age, disease state, etc.)?
A. I advise patients who desire reconstruction following mastectomy that there are a number of options for reconstruction. In most cases either saline or silicone gel-filled implants involves less demanding surgical procedures than do flap procedures (removal of skin from another area of the body to replace breast tissue) and gives equal appearances. In terms of the safety of silicone implants, there are no credible studies which show that the implants cause disease or adversely affect patients.Unfortunately, there is insufficient information to exclude the possibility that some patients will have adverse reactions. In the majority of patients who have had adverse reactions and whose courses I have reviewed, alternate and often treatable conditions could be identified that probably led to the symptoms, and these need to be carefully looked for in patients with complaints that are being attributed to îimplants. One of the most frequent conditions is menopausal symptoms or incomplete hormone replacement.The stage of the breast cancer and the patientøs age are not factors in choosing the approach to breast reconstruction, except insofar as this might influence surgical risk. Otherwise it is the womanøs choice.

Q. How has the usage of silicone gel-filled and saline implants changed since the beginning of the Food and Drug Administration (FDA) investigation?
A. The usage of silicone gel-filled implants has changed dramatically since Dr. Kessler (FDA Commissioner) first criticized the use of these implants. The most dramatic change is the general panic, even among patients who were not and are not experiencing problems with their implants. This mental anguish about potential problems, which may be reported by patients but not observed by examiners, has altered the decision-making process regarding the selection of any form of reconstruction.

Q. What are the latest findings and reports regarding the inability to perform an accurate mammogram due to the placement of silicone gel-filled breast implants?
A. Mammography can be adequately performed with implants in place. It does involve specific maneuvers and must be done cautiously so as not to rupture the capsule (fibrous tissue surrounding the implant) when the breast is compressed.

Q. What are your recommendations for follow-up and future cancer screenings after a woman has an implant placed?
A. The recommendations for follow-up are the same after implants are placed as they are in patients who have not been reconstructed or whose reconstruction was achieved using a flap procedure. These recommendations include physical examinations and laboratory evaluations while additional cancer therapy, necessary to treat any remaining cancer cells, is in progress (usually up to the first 6 months after diagnosis), every 3 months thereafter for the first year, every 6 months for the next 3 years, and then annually.

Q. What is being done to investigate the long-term effects of silicone implants such as immune-related disorders and cancer?
A. A number of studies are under way to assess the long-term effects of silicone implants. The studies must distinguish the type of implant and separate patients with urethane-coated implants and those with silicone elastomer implants. Remarkably, the frequency of breast cancer is lower in patients with silicone breast implants than in the general population. The frequency of autoimmune diseases (such as lupus erythematosis or scleroderma) appears to be similar to that in non-implanted controls, but adequate research has not been performed in this area.

Q. What other complications related to implants can occur, and how often do you see omen with these complications?
A. The principal complications related to implants are local effects such as infection at the site, distortion after rupture of the implant, and scarring. The frequency of complications varies widely and is dependent upon the technique used as well as the individualøs physical makeup.

Q. If you could share one message about silicone gel filled implants with health care professionals and lay persons, what would that message be?
A. The silicone gel-filled implants serve a genuine purpose, and the ratio of risks versus benefits still appears to be excellent, compared with alternatives. The widespread publication of anecdotal complications has caused more harm than any actual complication I have seen or of which I am aware. This fact notwithstanding, if someone wishes to have an implant removed, no objections to having this done should be raised

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