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Update on Silicone Breast Implants
Barry J. Cohen, MD, P.C., Diplomate,
There has been a great deal of information and even more misinformation spread about silicone implants. In the face of recent scientific studies about implants this presents an excellent opportunity to shed some light on this topic.
In the late 1980s and early 1990s, a concern arose that silicone gel implants were the cause of autoimmune disorders in women who had breast augmentation. Autoimmune disorders are a group of diseases in which the body attacks itself. In doing so, it causes many types of medical problems. Common autoimmune diseases are lupus and scleroderma.
In the early 1990s, under the pressure of significant negative media attention, and without sound scientific basis, the Food and Drug Administration removed silicone gel breast impIants from the market for use in cosmetic breast augmentation. Silicone breast implants had been permitted over the past several years in breast reconstruction for women who had breast cancer. Naturally, removing the implants from the market caused significant concern among women with implants. Plastic surgeons throughout the country were barraged with telephone calls. Unfortunately, since the Food and Drug Administration’s actions were not as a result of scientific fact, but rather anecdote, plastic surgeons could not advise their patients soundly. Many suggested the patients do nothing. Others succumbed to patient pressure and removed many of their patients’ silicone gel implants and replaced them with saline implants. Saline implants, in fact, have a silicone shell made of the hard polymer of silicone. They are filled with saline, or salt water, which is the same material used in intravenous fluids.
During the moratorium on silicone gel breast implants, surgery decreased.
Compared to the late 1980s breast implantation throughout the country was down by a huge margin. During the last few years, several well respected centers undertook studies to review the safety of silicone gel breast implants and to see if there was any scientific validity to the anecdotal experience being reported.
In June of 1994, the Mayo Clinic published one of the first articles about the safety of silicone gel breast implants. In this article, they compared women who had silicone gel breast implants in the prior years at the Mayo Clinic to age-matched control groups to see if there was any statistical difference in the incidence of autoimmune disease between these groups. For each woman who had silicone gel implants done at the Mayo Clinic, a randomly selected group of women the same age was picked out of their computer file. Their medical records were reviewed and the incidence of autoimmune disorders was tabulated. In this study, there was no difference in the incidence of autoimmune disorders between women with implants and those without. Subsequent studies have been done, including a recent study from Harvard University, which corroborated the Mayo Clinic’s findings. Nonetheless, silicone gel implants remain off the market and will remain off the market indefinitely. Saline implants, which have been used all along, are increasing again in popularity.
What are the real risks of silicone implants? The risks and complications associated with implant surgery include: infection, bleeding, internal and external scars, postoperative asymmetries, loss of nipple areolar sensation and an increased difficulty in interpreting mammograms postoperatively. With regard to infection, if an implant were to become infected the implant needs to be removed for several months prior to reinsertion. Excessive bleeding (which is fortunately unusual) can result in a return to the operating room to find the point of bleeding and to evacuate the collection of blood. Postoperative asymmetries are fairly infrequent. Loss of nipple sensation is quite rare.
Internal scars, known as capsule, is a problem that has confounded plastic surgeons since the inception of breast augmentation. Initially this was improved by placing the implants behind the pectoralis major muscle. This diminished the rate of capsular contracture. In the last several years the use of textured implants has also diminished the rate of capsular contracture. This still presents a risk for any woman undergoing augmentation, and capsular contracture can leave their breast somewhat hard and misshapen. This, however, is not a health risk, but purely an aesthetic deformity that can occur early or late after breast augmentation surgery.
Implant deflation is quite likely over the lifetime of saline implants. If a saline implant ruptures, deflation occurs rapidly and completely. The salt water that leaks is absorbed by the body and is completely harmless. All implants are warranted for five years by the manufacturer.
A study was done comparing the ability to interpret mammograms among those women who had no breast implants, those women whose implants were placed behind the muscle of their chest, and those women who had implants placed in front of the pectoralis muscle.
Radiologists noted that women who had no breast implants had the easiest to interpret mammogram followed by women who had implants placed behind their pectoralis muscle, with the worst interpretation seen in those women who had implants placed in front of their pectoralis muscle. It is important for women who have breast implants to alert their mammographers to this fact, so that additional views can be done. With displacement techniques of mammography, excellent mammograms can be obtained. There is no cause-and-effect relationship between breast cancer and silicone gel breast implants. Most women can breast-feed normally after breast augmentation.
Now that the breast implant scare is essentially over, many women are enjoying the results of this procedure, enabling them to have the body they have always wished for.