November 2003

Health Complications from Breast Implant Surgery:
A Canadian Study with Implications for the U.S.

By Aleina Tweed, British Columbia Centre of Excellence for Women's Health

For decades, women who have undergone breast implant surgery have reported high implant failure rates and unidentifiable illnesses. 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.

In Canada and the United States, approximately 20% of implant surgeries are for reconstruction, primarily after cancer or prophylactic mastectomy, and 80% are cosmetic augmentation. Such surgery is not considered medically necessary and is therefore paid for privately. However, when there are health consequences of this surgery - whether local complications or controversial systemic complications - Canadian women enter the public health care system for their care.

High complication rates have been well-documented. 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. Studies by implant manufacturers in the U.S. have reported that most reconstruction patients and a large proportion of augmentation patients report at least one serious complication within three years. In addition, there were 103,343 adverse reaction reports regarding silicone breast implants and 23,454 reports for saline implants received by the U.S. Food and Drug Administration between 1985 and 1996.

A new study by researchers at the Centre of Excellence for Women's Health in British Columbia finds 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). The study reported that women who have or have had breast implants:

• visited doctors and specialists significantly more often.
• were more than four times as likely to be hospitalized, and
• experienced more hospitalizations over the study period than women without implants.

All these differences were significant when age, marital status, education level, exercise, use of alcohol, and geographic region were statistically controlled. Types of implants (saline or silicone gel) did not significantly affect hospitalization or medical utilization.

The study 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 them that they no longer wanted breast implants. Forty percent of respondents had had their implants permanently removed.

One-third of the women in the study had implants for less than 10 years (some for just a few months) and 42% had implants for 11-20 years. Compared to most other studies, these women had implants for a longer period of time. Although more than two out of three (71%) reported their health as good or excellent, half had been diagnosed with at least one chronic illness, one in three had quit their job or reduced their work hours because of health problems, and more than half had problems doing housework or recreational activities because of health problems.

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 and the U.S. 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, in Canada all health complications resulting from the implant, including the removal of the implants, are covered by publicly funded health care. In the U.S., most of the medical care caused by these complications must be paid for by the woman herself.

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.

Most women with breast implants will require additional surgery or surgeries related to their implants. 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 common; 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%.

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 study by the U.S. FDA, two-thirds 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. When the filling is silicone gel, the silicone can migrate to other parts of the body and be difficult or impossible to remove.

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, lupus, 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. Cancer also remains a concern; a study by the National Cancer Institute found women with breast implants were more likely to die from brain cancer or lung cancer compared to other plastic surgery patients.

The link between breast implants and systemic complications is still not clearly understood. Epidemiologic research has not been conducted on large numbers of women who had implants for at least ten years, which would be a reasonable period of time to determine the health risks.

4. Psychological consequences
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. How many patients will admit, face-to-face with their surgeon, that they are not satisfied with the results of their surgery? How many surgeons will admit that their patients are not satisfied?

Many studies suggest that cosmetic surgery in general leads to immediate post-operative improvements in body image, quality of life and depressive symptoms. However, the FDA pointed out at their October 14 public meeting that the Inamed studies found a decline in most mental health and quality of life measures two years after getting breast implants, compared to before implantation. Those findings were consistent for augmentation or reconstruction patients. Other studies have found that women who have their breast implants removed without replacement 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 and women who have not undergone any cosmetic surgery. Since many women have their breast implants removed, these findings suggest that breast implant surgery leads to poorer psychological well-being, rather than better, for many women.