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For decades, women who have undergone breast implant surgery have reported high implant failure rates and general, unidentifiable illness. In 1992, silicone gel-filled implants were subject to government moratoriums in the United States and in Canada, until such time as their safety could be assured. In the years that have followed, researchers have tried to find answers. In the meantime, breast implantation continues to become more and more popular, with saline-filled implants taking the place of their silicone predecessors.
Many women who choose breast implantation are very happy with the results of their surgery. They report psychological and emotional benefit from their new body image. However, many women report side-effects and feel that their short-term and long-term health has been compromised.
In Canada, thousands of women have chosen breast implant surgery, including an estimated 25,000 or more in British Columbia alone. As in all of North America, approximately 20% of these surgeries are for reconstruction after cancer or prophylactic mastectomy, or to correct under- or non-developed breasts. The other 80% are performed as cosmetic augmentation. Such surgery is not considered “essential” and is therefore paid for privately rather than through public insurance. However, if there are health consequences to this surgery – ranging from the well established local complications to the very controversial systemic complications – these women enter the public health care system for their care.
Breast implant research is beset by challenges, not the least of which is the lack of a central registry allowing health care professionals or researchers to track women who receive breast implants or to do any follow-up. But we do know that a very high number of women have been affected by breast implant-related complications. A Mayo Clinic study in the United States, for example, found that 25% of women with breast implants suffered local complications requiring additional surgery within five years. We also know that there were 103,343 adverse reaction reports associated with silicone breast implants and 23,454 reports involving saline implants received by the U.S. Food and Drug Administration between January 1, 1985 and September 17, 1996.
In a recent study, researchers at the BC Centre of Excellence for Women’s Health have discovered relatively high complication rates for breast implantation in Canada as well. Data collected from a study group of 147 women who had undergone breast implant surgery were compared to data from a non-implant comparison group (583 women). Researchers found that women who have or have had breast implants visited doctors and specialists significantly more than women who had not undergone implant surgery. The study also indicated that women with breast implants were more than four times as likely to be hospitalized, and that the number of hospitalizations they experienced over the study period was significantly higher than among women without implants.
The researchers also found that over half (51%) of respondents from the study group reported at least one additional breast-implant related surgery subsequent to the initial implantation. Of those, half (49%) had undergone one additional surgery, 23% had undergone two, 11% had undergone three, and 17% had undergone four or more additional surgeries. For some of these women, the complications were enough to convince the women that they no longer wanted breast implants. 40% of respondents had had their implants permanently removed.
Breast implant surgery is not deemed medically necessary and is performed – and paid for – privately in the vast majority of cases. However, it appears to directly contribute to an increased need for public health care services among the women receiving these devices. If, as the literature suggests, serious local complication rates are at least 25% – and more likely are 50% or higher – there are many thousands of women in Canada who are using greater health care resources as a result of this surgery, and whose health and well-being may be at risk.
Complications with Breast Implantation
There are three major groups of health complications associated with breast implants: local complications, systemic complications and psychological complications. Breast implant surgery also carries the same risks associated with any surgical implantation of a medical device. All aesthetic complications (dissatisfaction with size, position, etc., of the implants) are not funded by public health care; however, all health complications resulting from the implant, including the removal of the implants, is covered by publicly funded health care.
1. Surgical complications
Any surgery – and breast implantation is no different – involves risks such as complications of general anesthesia, infection, haematoma, hemorrhage, thrombosis, skin necrosis, delayed wound healing and additional surgeries.
A woman who receives breast implant(s) will likely require additional surgery or surgeries related to her implant(s) over her lifetime. These procedures may include treatment of capsular contracture, correction of the implant’s size or position, infection control as the result of other local or systemic complications, or to prevent or treat leakage, rupture or other health problems.
2. Local complications
Local complications can range from very mild to very severe, and they affect a large percentage of women who undergo breast implant surgery. Capsular contracture is one of the most significant complications. Contraction of the wall of scar tissue surrounding the breast implant may cause hardness of the breast, discomfort and even severe pain. According to Health Canada, capsular contracture occurs, usually within two years of surgery, in approximately 25% of women who undergo breast implant surgery. Other researchers suggest the percentage is as high as 70%, and some estimate that 100% of women with breast implants will develop capsular contracture to some degree over the life of the implant.
Implant deflation and rupture caused by normal deterioration over time, breast trauma, undetected damage or shell weakness in the implant are significant complications; one study found that 70% of removed implants 11 to 15 years old were ruptured or leaking. In a U.S. government study, 2/3rds of 344 implanted women examined with MRI had ruptured implants. Deflation, leakage and rupture can result in the breast implant filling being spread through the body. The salt-water solution contained within saline-filled implants should be harmless. However, partly because of the semi-porous nature of breast implant shells and partly because of faulty valves and difficulties inherent in the sterilization of breast implant materials, it has been suggested that the saline filler does not remain sterile. In one study, most explanted saline-filled breast implants, regardless of their age, had microbial growth in the implant and in the capsule surrounding the implant. If the filler was so contaminated, it would no longer be considered harmless upon deflation or rupture.
Other complications include change in shape or volume of the breast; change in breast sensation; calcium deposits; mammographic interference, and breast/chest discomfort or pain and nipple discharge.
3. Systemic complications
Systemic complications appear most frequently several years after breast implantation. These complications tend to present as a cluster of symptoms, including those associated with autoimmune diseases, connective tissue diseases, “human adjuvant disease” and/or fibrositis/fibromyalgia-like disorders. (The classic autoimmune and connective tissue diseases thought to be associated with silicone implants are scleroderma, systemic lupus erythematosus, mixed connective tissue disease, rheumatoid arthritis and Sjogren-Larsson syndrome.) Women with breast implants have also reported granulomas and lymph node involvement, chronic flu, respiratory problems and infections. The cluster of symptoms reported by these women often includes those present in more than one such disease. Cancer also remains a concern – albeit a smaller one – associated with breast implants.
The link between breast implants and systemic complications is still not clearly understood. However epidemiologic research has not shown a significant increased risk.
4. Psychological complications
Unfortunately, studies of the psychological consequences of breast augmentation have been largely anecdotal, consisting primarily of surgeons’ reports of their patients’ satisfaction. These reports suggest that typically 70% or more of patients report satisfaction with their surgical outcome. However, such investigations clearly have serious problems. Firstly, how many patients will admit, face-to-face with their surgeon, that they are not satisfied with the results of their surgery? Secondly, how many surgeons will admit, face-to-face with their colleagues, that their patients are not satisfied?
There are many studies that suggest cosmetic surgery in general leads to immediate post-operative improvements in body image, quality of life and depressive symptoms. Other studies, however, have found that women who undergo removal of breast implants (explantation) report higher levels of breast anxiety, upper torso dissatisfaction and depression both before and after implant removal, compared to women who have undergone other cosmetic surgery (surgical controls) and women who have not undergone any cosmetic surgery (non-surgical controls). These findings suggest that breast implant surgery leads to poorer psychological well-being, rather than better, for many women
Policy Issues
In Canada the only breast implants now widely available are saline-filled implants (a silicone bag filled with salt water). These implants, however, have not been reviewed by Health Canada.
The Medical Devices Regulations were introduced in Canada in 1975. These required notification of devices within 10 days of being put on the market, but involved no evaluation. These regulations were amended in 1977 so that evidence of safety and effectiveness was required before marketing. The list of devices covered by this amendment did not, however, include breast implants. In October 1982, a further change to the regulations was implemented, which extended the pre-marketing review to all devices, including breast implants, designed to be implanted in tissues or bodies for more than 30 days.
The 1982 amendment required all implantable devices to go through a premarket evaluation of safety and effectiveness data in order to obtain a Notice of Compliance and be allowed for sale in Canada. This evaluation included a review by scientists at Health and Welfare Canada’s Bureau of Radiation and Medical Devices of animal and human test results and manufacturing data supplied by the manufacturer. However, the review was required only for devices introduced after the date the amendment became effective. Because most saline-filled implants were available for sale before this date, they were exempted from the pre-market review.
Currently, despite the moratorium on silicone gel-filled breast implants, Health Canada has begun allowing their use in certain circumstances. There are suggestions that their popularity is again growing. Even as these silicone gel-filled implants are being reintroduced, there has still been little evaluation of the effects of the saline-filled implants that are currently widely available. This represents a gap in public policy and should be addressed by Health Canada.
From Health Care Utilization Among Women Who Have Undergone Breast Implant Surgery by Aleina Tweed, from the British Columbia Centre of Excellence for Women’s Health. Full report available online at, www.bccewh.bc.ca/PDFs/hcubreastimplants.pdf or call 604-875-2633.