are medical devices. Like all medical devices, they provide certain
benefits, but also pose certain health risks. If you are considering
breast implant surgery, it is very important to understand the nature
and extent of these risks before you make a decision. The decision
to choose breast implant surgery can only be made by you in consultation
with your doctor.
An Overview of Potential Risks Related to
Research the risks
before deciding on breast implant surgery so that you can make an
are not considered to be lifetime devices. Whether implant surgery
is for the purpose of reconstruction or augmentation, you will likely
need additional surgeries and visits to your surgeon over time. At
some point, your implants will probably have to be removed, and you
will have to decide whether or not to replace them.
In addition, most
women with breast implants will experience complications of some kind.
These include rupture, pain, disfigurement, serious infections, and
a condition called capsular contracture. This is a tightening of the
scar tissue, or capsule, that the body forms around breast implants.
Before you decide
to go forward with breast implant surgery, you should also consider
of the changes to the shape of the breast after implantation are
of the implants may leave unacceptable dimpling, puckering, wrinkling,
or other cosmetic changes to the breast.
implants may affect your ability to produce milk for breast feeding.
implants make routine screening mammography more difficult.
implant surgery carries the same general risks as other surgical
procedures. Check with your doctor for more information about the
women believe breast implants cause systemic illnesses such as autoimmune
disease or connective tissue disease. To date, there is no definite
proof that this is the case.
The History of the Breast Implant Controversy
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
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. Since then,
a number of large studies and reviews have concluded that this was
not the case. 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.
The Current Situation
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.
Minimizing Your Risks
Before you decide
to have breast implant surgery, you must consider all of the risks,
and weigh them against the potential benefits. When you finish your
research, give yourself a "cooling off" period of several weeks before
you commit to surgery. You and your surgeon should both sign the "informed
consent" form, and you should keep a copy for your records. All breast
implants sold in Canada contain a patient labelling insert, which
identifies all potential risks related to breast implant surgery.
You should take the time to read it carefully before making a decision.