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 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.