Breast Implants

Breast implants consist of a silicone shell filled with a saltwater solution called saline. Historically, breast implants were filled with silicone gel, but silicone gel was banned in 1992 due to safety issues. Saline implants are either round or teardrop shaped, and the implant surface can be smooth or textured.

Textured implants were created because it was believed that they would reduce the risk of capsular contracture. Capsular contracture is a risk associated with breast augmentation that results in the hardening of the tissue surrounding the breast. To date, there has been no hard evidence to support the textured implant theory, and in fact, textured implants can increase the risk of rippling in small-breasted women.

According to the U.S. Food and Drug Administration, Department of Health and Human Services, several recent studies have found a slight increase in deaths due to suicide among women with cosmetic breast implants. The reason for this increase is unknown, although some suggest that this may be due to underlying psychological problems in women who get breast implants for cosmetic reasons. Others have suggested that women may be distressed because of the burden of breast implant complications.

We do not recommend breast augmentation surgery. However, if you decide to proceed, we do recommend asking lots of questions and getting clear answers. And we hope you will change your mind.

Special note to women with implants: Patients with breast implants should continue to be screened for breast cancer as recommended and should always inform clinicians performing the screening about their implants.

For an excellent video which provides a non-biased view of breast augmentation surgery, check out Breast Enlargement: Woman to Woman, produced in collaboration with The Breast Center in Van Nuys, Ca. During the video you will hear the personal breast augmentation stories of hundreds of women and the views of the world's leading authorities on breast enlargement, breast cancer, and general plastic surgery.

Breast Implant History

Starting in the 1960s, silicone gel-filled and saline-filled breast implants were sold in Canada for both augmentation and reconstruction purposes. The first breast implants all had smooth surfaces and relatively thick shells.

A great number of changes have been made since the introduction of breast implants in 1962. Over the years manufacturers have altered the shell strength and composition, provided barrier layers to limit gel leakage, modified valves used in saline implants and changed the thickness of the silicone gel used. These changes have been made with an aim to improve the safety and clinical performance of these devices.

In the past, scientific literature raised a number of concerns regarding possible systemic illnesses that might be associated with silicone gel-filled breast implants. On January 6, 1992, Health Canada asked manufacturers to stop the sale of these implants in Canada until further studies could be done. A similar decision was made in the United States and silicone gel-filled breast implants were removed from general sale. To date, there is no definite answer to this issue. The studies do however point out the need for women to understand the potential risks involved with breast implants. They also indicate a need for further studies to address other risks.

Today, only saline-filled breast implants, with smooth or textured surfaces, are available for open sale in Canada. At this time no manufacturer is licensed to sell silicone gel-filled breast implants in Canada. Doctors who wish to obtain silicone gel-filled implants for their patients on a case-by-case basis may apply in writing to Health Canada's Medical Devices Bureau. Each application is evaluated by Bureau staff before access is granted.

Editor's Note: Fifty-one percent of women who have reconstruction or augmentation surgery have to have follow up surgery due to complications. Forty percent of all women who under go either of these types of surgery eventually decide to have their implants permanently removed. This should provide significant evidence that breast surgery carries significant risk, continued pain and extreme dissatisfaction.

Breast Implants and Breast Cancer

In one of the largest studies on the long-term health effects of silicone breast implants, researchers from the National Cancer Institute (NCI) in Bethesda, Md., found no association between breast implants and the subsequent risk of breast cancer. The study is published in the November issue of Cancer Causes and Control.

Breast implants first appeared on the market in 1962. Manufacturers initially assumed that the implants were biologically inactive and therefore would have no harmful effects. However, over the past two decades there have been a number of reports of connective tissue disorders and cancers among implant patients.

In 1992, because of the lack of sufficient evidence on the long-term safety of implants, the Food and Drug Administration (FDA) restricted the use of silicone breast implants to women seeking breast reconstruction in controlled clinical trials. Congress directed the National Institutes of Health to undertake a large follow-up study to evaluate the long-term health effects of the implants.

This is the first part of our analysis of the health risks from the study, said Louise A. Brinton, principal investigator from NCI's Division of Cancer Epidemiology and Genetics (DCEG) in Bethesda, Md. For women followed for more than 10 years there was no change in breast cancer risk. Our results do not confirm the findings from several other studies that exposure to implants reduces a woman's risk for breast cancer. This may relate to the longer follow-up in this study as compared with most others.

Source: National Cancer Institute

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Breast Implants