At the time of approval, however, the FDA announced that it would conduct a study of 80,000 women over 10 years to determine the safety of silicone implants once and for all, an acknowledgment that the agency needed to gather more information about their long-term impact on women’s health. In the meantime, potential recipients would be free to use their judgment and get them if they wish.
FDA approved saline implants in 2000, after a review process that looked at two-years worth of data for a device that resides in women’s bodies for decades.
In 2003, the head of the FDA’s Center for Devices and Radiological Health, Dr. David Feigal, said in relation to implants: People have the misconception that an FDA-approved product is safe, but, actually, the agency evaluates products to see if risks outweigh benefits and then it’s up to “the consumer to decide whether or not they’re willing to take those risks.” And further back in 2000, in a press release announcing FDA approval of saline implants, Dr. Feigal said, “It’s clear from these studies that there is a possibility that a substantial number of women who get these implants will require additional surgery at some point to remove or replace their implants because of complications.”
So, yes, both saline and silicone implants have FDA approval, but this should not be interpreted as an endorsement of safety. It is the responsibility of women considering implant surgery to assess the available safety information before going through with the procedure.
]]>Though many researchers believe the long-term health risks are still unknown, local complications from implant surgery are recognized and well documented. Studies have shown that within the first three years of getting implants for the first time, almost half of the women experience one local complication such as pain, infection, hardening or the need for additional surgery. This number soars to about 75 percent among breast cancer patients.
An FDA team reported in 2001 that women with ruptured silicone implants are significantly more likely to be diagnosed with fibromyalgia and other illnesses. A 2001 National Institutes of Health study shows a 21 percent overall increase in cancers for women with silicone breast implants compared to the general population, and the incidence of leukemia and stomach, cervical, vulvar and brain cancers twice as high for women with implants.
]]>The price of breast augmentation surgery costs about $6,000. When the FDA approved silicone gel breast implants in November 2006, it stated that women with these implants should have a breast MRI three years after getting silicone implants and every two years after that. MRI exams cost about $2,000 each visit. Because almost half of silicone implants rupture by 10 years, they need to be replaced every seven years or so. A woman in her twenties getting her first implants is looking at perhaps an additional seven surgeries over the course of her lifetime and about 25 MRI screenings. This is a financial investment of at least $99,000, but likely more since replacement surgery is often more expensive.
Potential implant recipients must also keep in mind that cosmetic implant surgery is not covered by insurance, and treatment for complications from implants may not be covered either. In fact, once a woman becomes an implant recipient, her overall health coverage may change drastically: premiums may rise, and future coverage may be denied for breast cancer or other illnesses. It is critical for women to contact their insurance providers before undergoing the implant procedure to understand how implant surgery could impact their health coverage.
]]>One study found that nearly half of silicone implants fail within ten years and three-quarters of silicone implants rupture by twenty years. An FDA study of silicone implants found that most women had at least one broken implant after 15 years, and silicone had migrated outside the breast capsule in 21 percent of the women who agreed to MRI screening.
Saline implant failure is less of a health concern because saline implants deflate quickly, enabling immediate diagnoses and treatment, and the body easily absorbs the saline leakage. Saline implants, however, are encased in silicone shells, and silicone has been found outside the breast capsule in women with saline implants as well.
Women who receive implants must be prepared to have replacement surgery every seven to ten years.
]]>I felt educated and assured by my surgeon and by the information posted by the FDA. I got my implants more than two years ago. Over time, and then more rapidly last year, I became very ill. I felt as though I had the flu everyday and keeping up with my family and daily responsibilities was, with my exhaustion and joint pain, like fighting a wind tunnel. I visited five doctors, all of whom leaned toward auto-immune disorders, but did not like to label it as such. They put me through very toxic treatments, including a form of chemotherapy. They told me that my immune system was overactive, but as I don’t get many viral infections, my immune system must have been attacking the good areas of my body, which I began to believe was a sign of rejection of something foreign in my body. I can honestly say I never felt so sick in my life. I was going crazy because of the misinterpretation of so many doctors. And not being able to keep up with the daily demands of my family and my life, which was slipping out from underneath me, left me psychologically depressed.
Each doctor I consulted dismissed my implants as a possible reason for my sickness because I had no breast pain and, at least externally, I had great surgical results. They told me there is not medical evidence of problems with saline implants. Finally, I started researching on my own and came across so much testimony - unfortunately not from doctors, but from women who had symptoms that matched mine identically. It was then I decided to have my implants removed, as my health is worth more than any level of vanity. I desperately wanted my life back.
I went back to the plastic surgeon who had originally put them in and she was very emotionally supportive of my decision. Today, I am still somewhat symptomatic, but have to say I see improvement on many of the symptoms that once overtook me on a daily basis. I am smiling again. I am laughing again. I am enjoying my family, and most of all, I love my body and I have no regrets. I have made it a priority to educate women about this product I thought could make me feel so good but ended up making me so sick. If I had known the risks, I would have never have had the implants.
]]>The most common complication is capsular contracture, when the breast becomes painfully tight and hard. Capsular contraction may require surgical treatment. It may cause movement of the implant, which is often disfiguring. Other common problems of silicone or saline implants include loss of nipple sensation, breast pain and rashes.
Women thinking of silicone implants should be aware that silicone has been known to migrate away from the breast, and there have been cases where the substance has been removed from joints and internal organs such as the uterus, ovaries and liver. Women thinking of saline breast implants should be aware of the risk of infection from bacteria, mold, or fungus growing in the salt solution.
]]>Doctors who perform cosmetic breast implant surgery are also very motivated to grow this part of their practice. Cosmetic breast augmentation procedures are not covered by insurance, so recipients must pay out-of-pocket. This saves medical offices the time and resources they must devote to handling insurance claims. It also means that cosmetic implant surgery is more lucrative that other procedures because doctors can apply fees freely, without regard to guidelines and limits imposed by insurance companies.
Finally, any doctor - including dentists - is allowed by law to call him- or herself a plastic surgeon and perform breast augmentation surgery. Such doctors do not have the training and experience to properly judge and share with you potential risks. It is critically important that any woman considering implants make sure that the plastic surgeon she selects is board certified by the American Board of Plastic Surgery (ABPS). Certification guarantees that the doctor has graduated from an accredited medical school; has done a proper residency in general surgery, ENT, and plastic and reconstructive surgery; has passed written and oral board exams; and has practiced in the field for at least two years after training.
]]>One study found that up to 64 percent of the implanted women cannot produce enough milk, compared to 7 percent of women without implants. Another study of new mothers with saline implants found that 39 percent have problems breast-feeding. The ability to breastfeed after implant surgery may be related to the skill of the plastic surgeon and the kind of incision.
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