Breast Implant Complications
Breast Implant
Complications
Knowledge Can
Head Off Problems
In 1991, five women in their late thirties to midforties walked into a University of South Florida rheumatology clinic.
One woman complained of chronic fatigue, arthritis, hair loss, sweats and chest wall and shoulder pain.
Another complained of a red area on her breast and dry eyes and mouth, as well as muscle pain in her neck, chest, shoulder and upper back.
Another complained of night sweats, chronic fatigue, lung pain and shortness of breath.
Another complained of chest wall pain, nausea, muscle cramps and a slight fever.
And the fifth complained of a fever, fatigue and joint pain in her knees, wrists and ankles.
Five different women. Five sets of symptoms. One common problem: Each woman had a ruptured silicone implant.
The High Price of Implants
More than 41,000 women had breast implants inserted during 1992--a year after news surfaced about implant problems--while more than 25,000 women had their implants removed, reports the American Society of Plastic and Reconstructive Surgeons.
Most women had them removed because of physical problems, often caused by the contraction of the capsule around the implant. But 22 percent of the implants were removed simply because women were afraid.
As reported by Food and Drug Administration (FDA) researchers, one woman wrote: "I am a cancer patient and had double mastectomies. I decided to undergo surgery one more time for breast implants as an attempt to feel normal again. Since the date of my first implant, my health started deteriorating and continued to do so, to the point that I lost my job. I have been unable to work and to conduct any kind of normal life. All along I have questioned the relationship of the implants to the way that I've been feeling."
In 1992, 21 percent of all implants were inserted during postmastectomy surgery, while 79 percent were inserted because women felt their breasts were somehow inadequate.
But women have paid a high price for silicone breast implants. Calls from thousands of concerned women have flooded the FDA since the news first surfaced in 1991 about problems with breast implants; there were 40,000 during a five-month period alone, when a hotline was in operation. The comments revealed that women with breast implants are deeply worried about their health.
In a review of some of the letters that were received in 1992, the FDA reports that 40 percent of the women complained of breast pain, 39 percent complained of joint pain, and 35 percent complained of fatigue. What's more, nearly half of the women had been classified by their doctors as having some type of disease in which the immune system began to attack the body.
Her Problems Led
to Helping Others Sybil Niden Goldrich, a Beverly Hills homemaker who became a member of the Food and Drug Administration's working group on breast implants, developed breast cancer at the age of 43. She had a double mastectomy, followed by three sets of implants. She is now a member of the Claims Advisory Committee for the Breast Implant Litigation Settlement Program. This is her story. I was reconstructed 117 days after I had my mastectomies. The implants were polyurethane-foam-covered, silicone gel implants. There was no indication that there was a problem with the product, nor did my doctor talk about anything but the surgical side effects. And when I developed a rash and fever immediately after the implantation of the devices, I was told that I was allergic to Betadine, the antimicrobial solution they used to wash my chest. I wasn't. Several years later some technician put it on me by mistake, and no reaction showed up. Later on, however, I found out that the polyurethane foam used in my implants could cause an allergic reaction. I had the implants removed because they made my breasts very hard. My breasts turned blue--I later found out that was from infection underneath--and one of the scars under my breast didn't heal. It was a nightmare. Anyway, I got the second set of implants, which were not polyurethane-foam-covered. But the same thing happened--my breasts got hard. And one implant tried to push its way out through a nipple graft on my breast. I went right to the doctor and had the implant removed. Then I had another one put in its place, and then finally another set. All of them turned out to be the same. One implant traveled down and the other traveled up underneath the skin. I was hunched over for a year and a half. Finally I said, "I've got to get rid of these. I'm just too sick all the time." I heard about a doctor who was doing this new operation in which a flap of abdominal tissue is used to make new breasts. So I went in, he took the breast implants out and I had the abdominal flap operation. I'm very happy that I did. In 1988 I had a hysterectomy because I had an abnormally large tumor in my uterus. The surgeon took out the tumor, my uterus and my ovaries. He also did a liver biopsy at the same time because my liver looked "funny." In the lab, doctors found silicone in my uterus, my ovaries and my liver. The tumors were my body's attempt to wall off the silicone from the implants. Other tumors have been removed from my wrist and ankle. Since then another woman and I have started a self-help group called Command Trust in Beverly Hills that arranges for women to call each other and share their experiences. We've spoken to more than 25,000 women around the world. And if we've saved a few from the pain and difficulty that we've had, we've done well.
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The Smoking Gun?
Despite the fact that an estimated 1.5 million women have received implants since they were first marketed nearly 30 years ago, no one knows for sure whether breast implants trigger immunological diseases such as arthritis, lupus, a chronic inflammatory disease that affects the skin, joints, kidneys, nervous system and mucous membranes, or scleroderma, which causes hardening of the skin and scarring of internal organs.
No one knows because there is almost no reliable evidence. Studies conducted by the manufacturers may be tainted by self-interest. And while research at universities across the country is ongoing, it hasn't resulted in data from a large number of women studied over a long period of time, which is what's needed to reach reliable conclusions.
One important study was conducted by researchers at the Mayo Clinic in Rochester, Minnesota. Women in one Minnesota county who had received breast implants between 1964 and the end of 1991--a total of 749 women--were compared with 1,498 women who had not received implants. The researchers found that the women with implants did not have an increased risk of contracting connective tissue diseases, such as rheumatoid arthritis or lupus, or other illnesses studied.
Although the results of this study are not definitive because the number of women who had implants was small and the illnesses studied were uncommon, there are large studies under way on the safety of breast implants.
Meanwhile, smaller reports suggest two things: first, that silicone gel implants are the suspected cause, and second, that a woman's immune system perceives the silicone gel used in breast implants no differently than it does a splinter or any other foreign substance: It attacks. Also, one study of 31 women found that all implants had leaked after ten years.
In a study of three women at the Medical University of South Carolina in Charleston, researcher Richard Silver, M.D., found that immune system warriors called macrophages attacked the silicone breast implants and tried to destroy them, then tracked down and tried to destroy any silicone that had apparently leaked out of the implant and migrated to the joints, skin or lungs.
"We can't prove that the elemental silicon came from the implant," cautions Dr. Silver. "But the fact that we found macrophages in the implant's capsule suggests that that's where they may have originated."
Which implants are safest to use? "Saline, for now," says Loren Eskenazi, M.D., a member of the clinical faculty at Stanford University and co-chair of the women's caucus for the American Society of Plastic and Reconstructive Surgeons. "They're more prone to leaks than silicone, but saline leaking into the body won't hurt you. And if you do have a problem with leaks, your surgeon can replace the implant."
Another potential problem with saline is that it can obstruct the reading of a mammogram, she explains. "But a mammography technician who is experienced with implants can still get an adequate picture if there is no significant hardening around the breast implant," she says. In Europe, new implant filler materials are being produced that interfere minimally with mammography. They are currently awaiting FDA approval.
Preventing Complications
How can women who have breast implants prevent potential complications? Here's what Dr. Eskenazi suggests.
Keep up with your checkups. Keep up a regular routine of breast self-examination and mammography as indicated by your doctor. The gentle compression during a mammogram won't rupture an implant. If you have any questions, see your own surgeon or one recommended by the American Society of Plastic and Reconstructive Surgeons.
Leave well enough alone. "Many women who have had the most severe problems with their immune system have had multiple revisions and replacements of their implants," says Dr. Eskenazi. "We don't know why, but there seems to be some sort of stimulation of the immune system with repeated surgery that makes any problems worse."
That's why she recommends that women who are not experiencing any symptoms such as joint pains or rashes and are pleased with their implants leave them in place.
Consider removal. "You should have implants removed if you're significantly uncomfortable, if you're unhappy with the aesthetic result, or if you have any symptoms that began after the implants were inserted and you have no other medical explanation," says Dr. Eskanazi.
But before you go for surgery, she adds, make sure your doctor thoroughly checks out any symptoms you may have. If you have muscle and joint pains, for example, make sure your doctor runs tests for arthritis. If you have neurological symptoms--weakness while walking or unexpected falling, for example--make sure she checks for neurological problems.
Explore postremoval options. You should be aware that after removal of the implant, your breast will look flatter than it did before the implant was originally inserted. If you don't feel perfectly comfortable having your silicone implants removed and having nothing further done, ask for saline replacements, says Dr. Eskenazi.
So-called tram flap surgery--in which fat, muscle and skin are transferred from the belly to the breast--can be used to rebuild a breast. But the surgery is very expensive and may not be covered by insurance. Few if any surgeons are currently using natural tissue to replace implants originally intended to cosmetically enlarge the breasts. However, for women who have had breast cancer, this is an excellent option.
Take an active role. If you decide to have your implants replaced, ask your surgeon to give you any information she has on the replacement implant from its manufacturer or from the American Society of Plastic and Reconstructive Surgeons, says Dr. Eskenazi. Read the information carefully, take a friend to the doctor's office, ask your surgeon about anything you don't understand and tape record your doctor's answers. Then replay the tape, think carefully about what you want to do and make your decision.
