Breast Reconstruction - Most Common Risks
Rupture
Breast implants are not lifetime devices and cannot be expected
to last forever. Some implants rupture in the first few months after being
implanted and some rupture after several years, others are intact 10 or
more years after the surgery.
When silicone gel-filled implants rupture, some women may notice
decreased breast size, nodules (hard knots), uneven appearance of the
breasts, pain or tenderness, tingling, swelling, numbness, burning, or
changes in sensation. Other women may unknowingly experience a rupture
without any symptoms (i.e., "silent rupture"). Magnetic resonance imaging
(MRI) with equipment specifically designed for imaging the breast may be
used for evaluating patients with suspected rupture or leakage of their
silicone gel-filled implant.
Silicone gel, which escapes the fibrotic capsule surrounding the implant,
may migrate away from the breast. The free silicone may cause lumps
called granulomas to form in the breast or other tissues where the silicone
has migrated, such as the chest wall, armpit, arm, or abdomen.
Plastic surgeons usually recommend removal of the implant if it has
ruptured, even if the silicone is still enclosed within the scar tissue capsule,
because the silicone gel may eventually leak into surrounding tissues.
If you are considering the removal of an implant and the implantation of
another one, be sure to discuss the benefits and risks with your doctor.
FDA completed a retrospective study on rupture of silicone gel-filled breast
implants. This study was performed in Birmingham, Alabama and
included women who had their first breast implant before 1988. Women
with silicone gel-filled breast implants had a MRI examination of their breasts
to determine the status of their current breast implants. The 344 women
who received a MRI examination had a total of 687 implants. Of the 687
implants in the study, at least two of the three study radiologists agreed
that 378 implants were ruptured (55%). This means that 69% of the 344
women had at least one ruptured breast implant. Of the 344 women, 73 (21%) had extracapsular silicone gel in one or both breasts.
Factors that were associated with rupture included increasing age of the implant, the implant
manufacturer, and submuscular rather than subglandular location of the
implant. A summary of the findings of this study is also available on FDA's
website at http://www.fda.gov/cdrh/breastimplants/studies/biinterview.pdf
and http://www.fda.gov/cdrh /breastimplants/studies/biruptere.pdf.
Robinson et al. studied 300 women who had their implants for 1 to 25 years
and had them removed for a variety of reasons. Visible signs of rupture in
51% of the women studied were found. Severe silicone leakage (silicone
outside the implant without visible tears or holes) was seen in another 20%.
Robinson et al. also noted that the chance of rupture increases as the
implant ages.
Other studies indicate that silicone may escape the capsule in 11-23% of
rupture cases.
Capsular Contracture
The scar tissue or capsule that normally forms
around the breast implant may tighten and squeeze the breast implant.
This is called capsular contracture. Over several months to years, some
women have had changes in breast shape, hardness, or pain as a result of
this contraction. Although this seems to occur to some extent in most
women with breast implants, there are no reliable data on how often this
happens. If these conditions are severe, more surgery may be needed to
correct or remove the breast implants.
Making Breast Cancer Harder to Find
The breast implant could interfere
with finding breast cancer during mammography. It may "hide" suspiciouslooking
patches of tissue in the breast, making it difficult to interpret results.
The breast implant may also make it difficult to perform mammography.
Since the breast is squeezed during mammography, it is possible for a
breast 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 breast implants who receive a normal
exam. However, the benefit of the mammogram in finding cancer
outweighs the risk of additional x-rays.
Other Known Risks
Calcium Deposits in the Tissue Around the Breast Implant
Calcium depositsmay form in the tissue around a breast implant and may cause pain and
hardening of scar tissue. In some cases, these deposits may need to be
surgically removed.
Additional Surgeries
You should understand there is a fairly high chance
you will need to have additional surgery at some point to replace or
remove the breast implant. Also, problems such as rupture, capsular
contracture, infection, shifting and calcium deposits can require removal
of the breast implants. Discuss the risk of these additional surgeries with
your physician. Many women decide to have the breast implants replaced,
but some women do not.
Infection
Infection can occur with any surgery. The frequency of infection
with breast implant surgery is not known, but as a prospective patient,
you should ask your physician 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 breast 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 breast implant or around the incision). Swelling, pain,
and bruising may result. The chance of getting a hematoma is not known,
but if you are considering breast implants you should ask your physician
about his or her experience. If a hematoma occurs, it will usually be soon
after surgery. (It can 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 breast implant can stretch
the skin abnormally, depriving it of blood supply and allowing the breast
implant to push out through the skin. This complication usually requires
additional surgery.
Changes in Nipple or Breast Sensation
Changes in sensation may result
from breast implant surgery. These changes may be temporary or
permanent. They may affect sexual response and the response of the
nipple during breast feeding.
Shifting of the Breast Implant
Sometimes an implant may shift from its
initial placement, giving the breasts an unnatural look. If the breast
implant shifts, it may become possible to feel the breast implant through
the skin. Other problems with appearance could include incorrect breast
implant size, visible scars, uneven appearance, and wrinkling of the
breast implant.
Unknown Risks
Connective Tissue and Related Disorders. These illnesses include
autoimmune disorders such as lupus, scleroderma, and rheumatoid arthritis,
as well as disorders such as fibromyalgia and chronic fatigue syndrome.
Some women with breast implants have experienced these disorders as well
as a variety of symptoms that could be related to the immune system.
However, these symptoms may be present without breast implants or
connective tissue disease. It is unclear at this time whether the signs and
symptoms experienced by these women are related to their breast implants.
In some cases, women have reported a reduction in symptoms after their
breast implants were removed; in other cases, there was no change in
symptoms after their breast implants were removed.
Several human studies have been completed recently, which provide
substantial, but not complete, information about any possible link between
breast implants and immune-related disorders. These studies provide
reassurance that the risk of developing a connective tissue disease due to
breast implants is not high. Taken together, these studies tell us that the vast
majority of women with breast implants will not develop defined
immune-related disorders from their breast implants.
Breast-Feeding and Children. At this time it is not known what effect breast
implants have on lactation. Any breast surgery may impair breast feeding. A
woman with breast implants who has questions about risks while pregnant or
breast feeding should consult her physician.
Cancer. At this time, there is no scientific evidence that women with
silicone-filled breast implants are more susceptible to cancer than other
women. Two large studies have shown no increase in the incidence of
breast cancer in women with breast implants for either augmentation or
reconstruction. However, the possibility has not been ruled out and further
research is being conducted. Lifetime effects are currently unknown.
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