Healthy Skepticism Library item: 16

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Publication type: news

Researchers Call On Federal Government to Create Breast Implant Registry Health Complications from Breast Implant Surgery Common
From the British Columbia Centre of Excellence for Women's Health and the Canadian Women's Health Network 2003 Sep 29

Full text:

New Canadian study shows follow up procedures from private breast implant surgery draws on public health system

Aleina Tweed and Ann Pederson, researchers with the British Columbia Centre of Excellence for Women’s Health, are asking the government to keep better records. There are currently no mechanisms in Canada to track the health outcomes from plastic surgery, including breast implant surgery, despite the various health problems that have been linked to these implants.

An estimated 100,000 to 200,000 women in Canada have breast implants, approximately 80% for cosmetic breast augmentation and 20% for cosmetic reconstruction after mastectomy or to correct under- or non-developed breasts. In 1992, concerns over the safety of the silicone gel filler prompted the U.S. and Canadian governments to impose a moratorium on silicone gel-filled implants, effectively limiting their use to clinical trials or special dispensation. Saline filled implants have continued to be widely available. Inamed Corp., the manufacturer of McGhan implants, is currently applying to the FDA and to Health Canada to lift restrictions on the use of silicone gel-filled implants.

Health Problems Common – New Canadian Study

However, concerns over implant safety – whether silicone- or saline-filled – remain. International research indicates that the complication rate associated with breast implants is high. A study by the Mayo Clinic in the United States found that fully one-quarter (25%) of women with breast implants suffered local complications (complications directly affecting the breast/chest area) severe enough to require additional surgery within five years of implantation.

Further, between January 1, 1985 and September 17, 1996, the U.S. Food and Drug Administration received 103,343 adverse reaction reports associated with silicone breast implants and 23,454 reports involving saline implants.

In a recent Canadian study supported by the British Columbia Centre of Excellence for Women’s Health, Aleina Tweed focused not on the health outcomes of breast implantation, but on health care utilization as a marker of the potential physical and financial burden borne by women and by the public health system as a consequence of breast implant surgery.

Data collected from a study group of 147 women who had undergone breast implant surgery were compared to data from a group of 583 women without implants.

Ms. Tweed found that women who have or have had breast implants visited doctors and specialists significantly more, and were more than four times as likely to be hospitalized than the women without implants.

Women in the study group were twice as likely to be admitted to hospital electively, although the services accessed once admitted were similar.

One of the few differences was the increase in general and plastic surgery services among women with breast implants – services that we would expect to be associated with local breast-implant related complications.

Breast implant surgery is often not a one-time procedure. Following implantation, over half (51%) of respondents from the study group reported at least one additional breast implant-related surgery. Of these women, half (49%) reported one additional surgery, and nearly one-third (28%) reported three or more additional surgeries. For some of these women, the complications were enough to convince them that they no longer wanted breast implants. 40% of respondents had had their implants permanently removed.

Cosmetic breast augmentation is not considered “essential” medical care, and is therefore paid for privately rather than through public insurance. However, when there are health consequences to this surgery, women enter the public health care system for care.

Solution – Breast Implant Registry

Since most cosmetic surgery performed in Canada is done through private practice, there is no public record of even the number of surgeries performed, let alone their health outcomes. This includes breast implants surgery. This is slowly changing. Many countries worldwide have now established or are establishing breast implant registries.

These countries include the UK, the US, Denmark and others.

The establishment of such a registry for women in Canada is long overdue. Ann Pederson and Ms. Tweed have been involved in examining the Canadian and world stage in the hopes of convincing provincial and federal governments that a registry would benefit the women of this country. “Canada has the opportunity to join the international community in this important step towards protecting women’s health,” says Ms. Pederson, Policy and Research Manager for the British Columbia Centre of Excellence for Women’s Health.

Breast implants are again gaining popularity, according to the American Society of Plastic Surgeons. Yet despite their wide acceptance, knowledge about the benefits and risks is sketchy. “We simply don’t know enough about the effects of breast implants, and therefore cannot support women in making informed decisions,” says Aleina Tweed.