update - 2008 refer to site (among others)
The following document was sent to Plastic Surgeons by
the Department of Health and Human Services and is presented for your information.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug administration
9200 Corporate Boulevard
Rockville M D 20850
April 20, 1995
Information for Women Considering
Saline-filled Breast Implants
Saline-filled breast implants (silicone envelopes filled
with salt water) were already in use in 1976 when the
Food and Drug Administration (FDA) began regulating medical
devices. Under this 1976 law, manufacturers could continue
selling devices already on the market ("grandfathered").
But the 1976 law made it clear that at some time in the
future, FDA would require manufacturers to submit their
research data showing that these products are safe and
effective. Women need to know that until this call for
research data occurs, laboratory, animal, and human tests
on some of these "grandfathered" products -- including
saline breast implants -- may not have been completed
by the manufacturer or reviewed by FDA.
Women considering saline-filled breast implants for breast
enlargement or reconstruction should receive the following
information about implants (and, when appropriate, other
options for reconstruction) before surgery is scheduled.
This will allow them time to review the material and discuss
possible risks and benefits with her doctor. For some
women, breast implants can improve their quality of life.
Some breast cancer survivors believe that getting implants
has been an important part of their recovery. However,
other women find external breast forms to be satisfactory.
Reconstruction options include breast implants or surgery
using tissue from a patient' s own abdomen, back or buttocks
to form a new breast. This surgery requires sufficient
fat tissue and a longer operation, and like any other
procedure, it is not always successful. For each woman,
whether her goal is augmentation or reconstruction, the
benefits may be different.
With her doctor' s advice, each woman must decide whether
or not she wishes to accept the possible risks in order
to achieve the expected results.
Breast implant surgery presents the same general risks
associated with anesthesia and any other surgery. After
the surgery, there are other special risks related to
saline-filled breast implants. (The manufacturer's package
insert for these devices gives additional, more detailed
information. Your surgeon has a copy and can provide it
Most Common Risks
. Deflation. Breast implants cannot be expected to last
forever. Some implants deflate (or rupture) in the first
few months after being implanted and some deflate after
several years ; yet some seem to be intact 10 or more years
after the surgery. It is not known when deflation is most
to happen, The implant can break due to injury to the
breast or through normal wear over time, releasing the
saline (salt water) filling. Researchers are doing studies
to determine rupture rates over time. Whenever a saline-filled
implant does deflate, it usually happens quickly and requires
surgery to remove and, if desired, replace the ruptured
Since salt water is naturally present in the body, the
leaked saline from the implant will be absorbed by the
body instead of being treated as foreign matter.
. Making breast cancer harder to find. The implant could
interfere with finding breast cancer during mammography.
It can "hide" suspicious-looking patches of tissue in
the breast, making it difficult to interpret results.
The implant may also make it difficult to perform mammography.
Since the breast is squeezed during mammography, it is
possible for an implant to rupture during the procedure.
It is essential that every woman who has a breast implant
tell her mammography technologist before the procedure.
The technologist can use special techniques to minimize
the possibility of rupture and to get the best possible
views of the breast tissue. Because more x-ray views are
necessary with these special techniques, women with breast
implants will receive more radiation than women without
implants who receive a normal exam. However, the benefit
of the mammogram in finding cancer outweighs the risk
of the additional x-rays.
. Capsular contracture. The scar tissue or capsule that
normally forms around the implant may tighten and squeeze
the implant. This is called capsular contracture. Over
several months to years, some women have changes in breast
shape, hardness or pain as a result of this contraction.
No good data are available on how often this happens.
If these conditions are severe, more surgery may be needed
to correct or remove the implants.
Other known risks
. Calcium deposits in the tissue around the implant. When
calcium deposits, which are not harmful, occur, they can
be seen on mammograms. These deposits must be identified
as different from the calcium that is often a sign of
breast cancer. Occasionally, it is necessary to surgically
remove and examine a small amount of tissue to see whether
or not it is cancer. This can frequently be done without
removing the implant.
. Additional surgeries. Women should understand there
is a fairly high chance they will need to have additional
surgery at some point to replace or remove the implant
when and if it wears out. Also, problems such as deflation,
capsular contracture, infection, shifting, and calcium
deposits can require removal of the implants. Discuss
the risk of these additional surgeries with your physician,
Many women decide to have the implants replaced, but some
women do not.
. Infection. Infection can occur with any surgery. The
frequency of infection with implant surgery is not known,
but a prospective patient should ask her surgeon what
his or her experience has been. Most infections resulting
from surgery appear within a few days to weeks after the
operation. However, infection is possible at any time
after surgery. Infections with foreign bodies present
(such as implants) are harder to treat than infections
in normal body tissues. If an infection does not respond
to antibiotics, the implant may have to be removed. After
the infection is treated a new breast implant can usually
be put in.
. Hematoma. A hematoma is a collection of blood inside
the body (in this case, around the implant or around the
incision). Swelling, pain and bruising may result. The
chance of getting a hematoma is not known, but a woman
thinking about breast implants should ask her surgeon
about his or her experience. If a hematoma occurs, it
will usually be soon after surgery. (It can but also occur
at any time after injury to the breast.) Small hematomas
are absorbed by the body, but large ones may have to be
drained surgically for proper healing. Surgical draining
causes scarring, which is minimal in most women.
. Delayed wound healing. In rare instances, the implant
stretches the skin abnormally, depriving it of blood supply
and allowing the implant to push out through the skin.
This complication usually requires additional surgery.
. Changes in feeling in the nipple and breast. Feeling
in the nipple and breast can increase or decrease after
implant surgery. Changes in feeling can be temporary or
permanent and may affect sexual response or the ability
to nurse a baby. (See the paragraph on breast-feeding
. Shifting of the implant. Sometimes an implant may shift
from its initial placement, giving the breasts an unnatural
look. An implant may become visible at the surface of
the breast as a result of the device pushing through the
layers of skin. Further surgery is needed to correct this
problem. If the implant shifts, it may become possible
to feel the implant through the skin. (Placing the implant
beneath the muscle may help to minimize this problem.)
Other problems with appearance could include incorrect
implant size, visible scars, uneven appearance, and wrinkling
of the implant.
In addition to these known risks, there are unanswered
questions about saline-filled breast implants. For example,
can the implants bring on symptoms of autoimmune diseases
such as lupus, scleroderma, and rheumatoid arthritis ?
Can they bring on neurological symptoms similar to multiple
sclerosis in some women ? Can the implants increase the
risk of cancer ? (Because saline-filled implants contain
only salt water, any risk that might be related to silicone
gel would not occur with this type of product.) There
is some concern, but little information, about possible
risks from the silicone rubber material of the envelope.
Also, questions have been raised about the potential for
the saline to become contaminated with fungus or bacteria.
If so, these organisms might be released into the woman's
body if her implant deflated.
. Autoimmune diseases. According to scientific studies,
women with breast implants in general are not at an increased
risk for autoimmune or connective tissue diseases. However,
these studies are too small to detect whether there might
be a slightly increased risk of any one of these rare
diseases. Also, these current studies have looked only
for the symptoms of known autoimmune diseases, rather
than the variety of symptoms that some women report experiencing.
Some of the reported symptoms include: . Swelling and/or
joint pain or arthritis-like pain . General aching . Unusual
hair loss . Unexplained or unusual loss of energy . Greater
chance of getting colds, viruses, and flu . Swollen glands
or lymph nodes . Rash . Memory problems, headaches . Muscle
weakness or burning . Nausea, vomiting . Irritable bowel
. Breast-feeding and children. Questions have been raised
about whether or not breast implants present safety concerns
for nursing infants of women with breast implants. Some
women with breast implants have reported health problems
in their breast-fed children. Only very limited research
has been conducted in this area, and at this time there
is no scientific evidence that this is a problem. It is
not known if there are risks in nursing for a woman with
breast implants or if the children of women with breast
implants are more likely to have health problems.
. Cancer. At this time, there is no scientific evidence
that women with saline-filled breast implants are more
susceptible to cancer than other women.
PLASTIC SURGEONS' BREAST IMPLANT INFORMATION