Breast Implants - Breast Augmentation FAQ -
Risks
Center for Devices and Radiological Health /
CDRH
November 2000
[Abstract] Full Text [PDF]
Breast
augmentation - series: Procedure
FREQUENTLY ASKED QUESTIONS
What information should I get for my
records?
If you are going to receive a breast implant,
there are several important items of information you should have for your
personal records before your surgery.
-
Patient information: This
may be in the form of a brochure, an information sheet, or an informed
consent document.
For the approved saline-filled breast
implants made by Mentor and McGhan, there are patient informed decision
brochures that are available through your doctor, Mentor or McGhan, or on
FDA’s website at http://www.fda.gov/cdrh/breastimplants.
These brochures describe the approved uses for those implants, factors to
consider in your decision, risks, clinical results, etc. The brochures are
to assist you in making your decision about whether or not to have these
saline-filled breast implants.
To date, for all other breast implants
other than Mentor’s or McGhan’s saline-filled implants (whether
saline-filled or silicone gel-filled), you must be enrolled in a
FDA-approved clinical study called an IDE study to receive the implant in
the U.S. Additionally, you must sign the IDE informed consent document
before surgery. The informed consent document for an IDE study describes
the purpose of the clinical study, the risks associated with breast
implants, etc. It is advisable that you obtain a copy of the informed
consent document from your doctor well in advance of your surgery so that
you may better understand the risks involved and ask questions. This
should be kept as part of your records.
Note that the informed consent document
described above is required for you to participate in an IDE study. This
should not be confused with a standard consent form that a hospital
requires to be signed by any patient.
Aside from the informed consent
document required to participate in an IDE study, the patient labeling for
the Mentor and McGhan saline-filled breast implants and this consumer
handbook provide additional information for you to consider in your
decision about whether or not to have breast implants.
-
Package insert:
You should also ask for a copy of the manufacturer's package insert for
the breast implant you will receive. Each package insert contains
important information about the precautions to be taken and the risks
associated with the specific brand of implant. You should use this insert
as a basis for discussion about the surgery with your doctor, and keep it
for future reference.
- Manufacturer's device sticker:
A copy of the sticker identifies the brand of the implant you will
receive, its size, and the manufacturer's lot number. This data should be
part of your personal medical record. It will be useful if you should have
problems following surgery or seek care from another health care provider.
Therefore, you should seek this information as soon as possible because
doctors and hospitals do not keep medical records forever.
- Insurance coverage:
Breast implant surgery (whether breast reconstruction or augmentation)
and/or treatment of complications may not be covered by your health
insurance. You should check with your insurance company regarding these
coverage issues because, for some women, health insurance premiums may
increase, coverage may be dropped, and/or future coverage may be denied.
Before surgery, be sure to get, in writing, answers from your insurance
company to these questions, at minimum:
- Does my policy cover the costs of the
implant surgery, the implant, the anesthesia, and other related
hospital costs? To what extent?
- Does it cover removal and/or
replacement of the implants if this becomes necessary? To what extent?
- Does it cover the cost of detecting or
treating a complication as a result of either the implant or the
reconstruction? To what extent?
- Will there be an increase in my
insurance premium? To what extent?
- Will future coverage be affected? To
what extent?
Note that policies on coverage may change
from year to year due to numerous reasons.
Should I tell other doctors in the future
about my implants?
Yes. Whenever you give a medical history, be
sure to inform the doctor that you have breast implants, just as you would
tell him or her about other previous surgical procedures.
Do I need to get regular mammograms?
Women with breast implants who are in an age
group where routine mammograms are recommended should be sure to have these
examinations at the recommended regularly scheduled times. (Those who have had
breast cancer surgery on both breasts should ask their doctors whether
mammograms are still necessary.) However, women should be aware that breast
implants may interfere with the detection of cancer and that mammograms do not
detect implant ruptures or leakage. The Breast Implant Risks section discusses
rupture/leakage and the method of detection of rupture/leakage.
What about the TrilucentTM
(soybean oil-filled) implants?
The TrilucentTM is a breast
implant with a silicone shell filled with purified soybean oil. LipoMatrix
Inc., a subsidiary of Collagen Aesthetics, Inc. (DBA Collagen Corporation) was
the former owner of this IDE. Now AEI Inc. (a company owned by Inamed) is the
owner of this IDE. About 470 women (about 200 of who are in the U.S.) were
enrolled in an IDE study to evaluate the safety and effectiveness of the
implant. In 1997, the manufacturer stopped enrolling new patients into the IDE
study. The IDE patients are being evaluated, and no new clinical studies are
planned for this breast implant.
While these implants were never approved for
marketing in the U.S., they were approved for marketing in Europe. The Medical
Device Agency (MDA), the British equivalent of the FDA, removed the TrilucentTM
implant from the market in the United Kingdom in March 1999 as a result of
their investigation of reported adverse events. Their concern was that
breakdown products of the soybean oil filler in TrilucentTM
implants removed from some women were significantly different than the
breakdown products predicted during preclinical testing. These breakdown
products could result in some substances that are biologically active (react
with body tissues), the toxic effects of which have not been adequately
evaluated, but which could be cancer-causing. The MDA recommended that a woman
with the TrilucentTM breast implant should consult her general
practitioner or the doctor who performed the initial implantation. The MDA
also advised that a woman should seek her doctor immediately if she notices
unusual breast swelling or inflammation associated with a TrilucentTM
breast implant.
After more research, in June 2000, the MDA
issued a Hazard Notice entitled, "TrilucentTM Breast Implants:
Recommendation to Remove" and a statement entitled, "Statement on
the Safety of Trilucent Breast Implants." Both are available on MDA’s
website at http://www.medical-devices.gov.uk.
Based on new toxicology information provided by AEI Inc. and reviewed by the
Independent Advisory Group set up by MDA, the MDA recommended several
immediate actions for women implanted with the TrilucentTM breast
implants in the U.K. Among these actions, women were advised to have their
TrilucentTM breast implants removed and to avoid pregnancy and
breast-feeding while they still are implanted with their TrilucentTM
implants. FDA worked with McGhan Medical (a company owned by Inamed and
responsible for the U.S. clinical study) to develop a plan to contact all
patients in the U.S. IDE study and request that they come in for an evaluation
and for a discussion of the MDA findings and recommendations. Additional
information from McGhan is available at http://www.mcghan.com/patient/brecontri.html
and http://www.trilucentinfo.com/.
If you have questions regarding the TrilucentTM implant, you should
contact McGhan (refer to Breast
Implant Resource Group section).
Is there a test to detect silicone in the
body or to determine if an individual is sensitive to silicone?
Currently, there are no FDA-approved tests to
detect silicone in the body or to determine whether a woman's immune system is
sensitive to any component of silicone breast implants.
Determining that silicon or silicone is
present in body fluids does not indicate whether a person is sensitive to
these substances or at risk for any specific disease. (Silicon is an element
that is one component of the polymer silicone and is one of the most abundant
elements on the earth. Everyone is exposed to silicon.) Some researchers
reportedly have developed a test that can detect antibodies to silicone in
blood; however, the proven accuracy and usefulness of the test has not been
determined. Some researchers have also reported that a test called the
Anti-Polymer Antibody Assay may be able to distinguish signs and symptoms of
disease ranging from mild to severe in women with implants. However,
the biologic basis for the assay has not been established. The test remains to
be proven as accurate, and, at this time, the clinical usefulness of the test
results has not been determined.
Even if such antibodies were detected, the
importance would be unclear. Antibodies to silicone would not necessarily mean
that silicone is harmful or that a person would necessarily have an adverse
reaction to it. Some researchers have also reportedly developed a test to
detect if a woman's immune system is sensitive to silica, a component found in
silicone breast implants. The accuracy of this test also has been questioned,
and it is not clear at this time whether the results of this test have
clinical usefulness.
Even if simple techniques to detect silicone
were available, they might not be useful in detecting a rupture because small
amounts of silicone oil ordinarily bleed even from intact implants. Further,
because silicone is found in food and many other products, including commonly
used medicines and cosmetics, the tests would not easily determine whether the
silicone came from the implant or another source.
Breast Implant Risks
The Institute of Medicine’s (IOM) 1999
study of silicone breast implant safety found that local complications with
silicone breast implants were the primary safety issue, that they have not
been well studied, and that information on these complications is crucial for
women deciding whether or not they want breast implant surgery. 1
There are risks or complications associated
with any surgical -procedure, such as the effects of anesthesia, infection,
swelling, redness, bleeding, and there are complications specific to breast
implants. These complications and others are described below.
1. CAPSULAR CONTRACTURE
Capsular contracture occurs when the scar
tissue or capsule that normally forms around the implant tightens and squeezes
the implant. There are four grades of capsular contracture: Baker Grades I –
IV.
The Baker grading is as follows
Grade I - breast normally soft and looks natural
Grade II - breast little firm and looks normal
Grade III - breast firm and looks abnormal (visible distortion)
Grade IV - breast hard, painful and looks abnormal (greater distortion)
Correction of capsular contracture ranges
from surgical removal of the implant capsule tissue to removal (and possible
replacement) of the implant itself. Capsular contracture may happen again
after this additional surgery.
Photograph 1 below shows Grade IV capsular
contracture in right breast of a 29-year-old woman seven years after
subglandular (on top of the muscle and under the breast glands) placement of
560cc silicone gel-filled breast implants.2
Photograph 1
2. DEFLATION or RUPTURE
When silicone gel-filled implants rupture,
some women may notice decreased breast size, 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 may escape from the fibrotic capsule around
the implant, may migrate away from the breast, and may cause lumps called
granulomas to form in the breast, 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.
When saline-filled breast implants deflate,
the saline solution leaks either through an unsealed or damaged valve or
through a break in the implant shell. Implant deflation can occur immediately
or progressively over a period of days, months, or years and is noticed by
loss of size or shape of the implant. Additional surgery is needed to remove
deflated implants.
For silicone gel and saline-filled implants,
some causes of rupture or deflation include:
- damage by surgical instruments during
surgery
- overfilling or underfilling of saline
(only) implant
- capsular contracture
- manually squeezing the breast to break the
hard capsule
- trauma, injury, or intense physical
manipulation
- excessive compression during mammographic
imaging
- placement through the belly button
- normal aging of the implant
- unknown/unexplained reasons
Photograph 2 below shows a
30-year-old woman’s left saline-filled breast implant deflation. The
suspected cause was the leaf-valve design of the implant, which is no longer
being used by manufacturers.
Photograph 2
3. ADDITIONAL SURGERY & REMOVAL
WITHOUT REPLACEMENT
Women with breast implants may need additional
surgery at some point to replace or remove her implant(s) due to problems such
as deflation, capsular contracture, infection, shifting, and calcium deposits.
Women who do not have their implants replaced may have cosmetically
undesirable dimpling, puckering of the breast following removal of the
implant, or other unsatisfactory cosmetic outcomes.
Photograph 3 below shows the same 29-year-old
woman in Photograph 1 one year after removal of her silicone gel-filled breast
implants without replacement. Patients with large implants, particularly those
inserted subglandularly (on top of the muscle and under the breast glands),
may have a major cosmetic deformity if they choose not to replace them or to
undergo additional reconstructive surgery.
Photograph 3
4. PAIN
Women may feel pain of varying degrees and
lengths of time following breast implant surgery. In addition, improper size,
placement, surgical technique, or capsular contracture may result in pain. You
should tell your doctor if you have pain.
5. DISSATISFACTION WITH COSMETIC
RESULTS
Dissatisfying results such as wrinkling,
uneven sizes, implant shifting, incorrect size, unanticipated shape, ability
to feel implant, scar deformity, irregular or raised scarring, and/or sloshing
may occur. Careful surgical planning and technique can reduce but not always
prevent such results. For saline-filled implants with valves, you may be able
to feel the valves. Repeated surgeries to improve the appearance of the
breasts and/or to remove ruptured or deflated prostheses may result in an
unsatisfactory cosmetic outcome.
6. INFECTION
Infection can occur with any surgery and at
any time. Most infections appear within a few days to weeks after the
-surgery. Infections with an implant present are harder to treat than
infections in normal body tissues because infection may not respond to
antibiotics. The implant may have to be removed and replaced after the
infection is gone.
7. HEMATOMA/SEROMA
Hematoma is a collection of blood inside a body cavity and a seroma is a
collection of the watery portion of the blood around the implant or around
healing. A small scar can form or a rupture may occur if the implant is
damaged during draining the incision. Post-operative hematoma and seroma may
contribute to infection or capsular contracture. Swelling, pain, and bruising
may result. A hematoma usually occurs soon after surgery but may occur at any
time or after injury to the breast. While the body absorbs small hematomas and
seromas, large ones will require the placement of surgical drains for proper
healing. A small scar can form or a rupture may occur if the implant is
damaged during draining.
8. CHANGES IN NIPPLE AND BREAST
SENSATION
Feeling in the nipple and breast can increase
or decrease after implant surgery. The range of changes varies from intense to
no feeling in the nipple or breast after surgery. Changes in feeling can be
temporary or permanent and may affect sexual response or the ability to nurse
a baby.
9. CALCIUM DEPOSITS IN TISSUE AROUND
IMPLANT
Calcium deposits can be seen on mammograms and
can be mistaken for possible cancer, resulting in additional surgery to biopsy
or remove the implant to distinguish these deposits from cancer. Calcium
deposits may be felt as modules or bumps under the skin around the implant.
10. DELAYED WOUND HEALING
In some cases, the incision site fails to heal normally or takes longer to
heal.
11. EXTRUSION
Unstable or weakened tissue covering and/or interruption of wound healing may
result in extrusion, (when the breast implant comes through the skin). Surgery
needed to correct this can result in unacceptable scarring or breast tissue
loss.
12. NECROSIS
Necrosis, the formation of dead tissue around the implant, may prevent wound
healing and require surgical correction and/or implant removal.
A permanent scar may form.
13. TISSUE ATROPHY/CHEST WALL
DEFORMITY
Pressure of the breast implant may cause the breast tissue to thin and shrink.
This can occur while implants are still in place or following implant removal
without replacement
14. INTERFERENCE WITH MAMMOGRAPHY
Interference with mammography due to breast
implants may delay or hinder the early detection of breast cancer either by
hiding suspicious wounds, injuries, or tumors or by making it more difficult
to include them in the image. Implants increase the difficulty of both taking
and reading mammograms. Women who undergo reconstruction and have some breast
tissue remaining must continue to have mammography of that breast, as well as
of the other breast, to detect breast cancer. Mammography requires breast
compression (hard pressure) that could contribute to implant rupture. When
making appointments, women with implants should tell the scheduler that they
have breast implants. Before mammography, women should also tell the
radiologic technologist about their implants. The technologist will then take
extra care during compression to reduce the risk of implant rupture. The
technologist will also use the special displacement views to see as much as
possible of the breast tissue.
15. UNEXPECTED MILK PRODUCTION AND
LEAKAGE
Following breast implant surgery, your body
may begin to produce milk. This production may cease spontaneously or after
medication is given to stop milk production. In other cases, removal of the
implant(s) may be needed.
Please refer to our breast implant consumer
handbook entitled, “Breast Implants – An Information Update – 2000”
for a more detailed description of these risks, as well as a description of
other illnesses that women believe are related to their implants. The handbook
is available from the FDA website at: http://www.FDA.gov/CDRH/breastimplants/.
Citation: Article published on the Internet by
Center for Devices and Radiological Health / CDRH. 1Safety
of Silicone Breast Implants. Institute of Medicine; National Academy Press,
Washington, D.C. 2000. (IOM Report)
2All photographs W. Peters, Ph.D., M.D., F.R.C.S.C., University of
Toronto
