This list of
FDA-mandated precautions regarding silicone was posted in November 2006,
immediately after the FDA's release of silicone implants, and in
response to the FDA requirement that these issues be discussed with
patients prior to choosing silicone. Note well that these statements are
those of the FDA, and not my personal view as an investigator in the
Silicone Core Gel Study. As noted below, many of the statements
seem to show bias against silicone, and some seem completely unfounded
in my estimation. Nonetheless, in response to the FDA requirement, the
following statements are reproduced, with parenthetical comment, as
appropriate:
Silicone breast implants
are permitted by the FDA for the following uses
Breast Augmentation
for women at least 22 years old including primary breast
augmentation to increase breast size, as well as revision surgery to
correct or improve the result of previous breast augmentation. (I
have no idea of the rationale for the arbitrary age of 22 yrs.-TMD)
Breast
Reconstruction including primary reconstruction to replace breast
tissue that has been removed due to cancer or trauma, or that has
failed to develop properly due to a severe breast abnormality. Breast
reconstruction includes revision surgery to correct or improve the
result of an original primary breast reconstruction surgery.
Breast implants (silicone
or saline) are not considered lifetime devices. (Eventually the implants
will fail, and require replacement---TMD)
Additional surgeries will
likely be needed (such
as to replace a ruptured implant--TMD)
According to the FDA,
when implants are replaced, the risk of future complications increases
compared to first time surgery. (Dr DeWire's comment: This may
reflect the complex nature of the problem that led to the replacement or
revision.)
The FDA recommends
screening MRI breast exams (sophisticated imaging studies done by
radiologists, but not entailing use of x-rays) starting 3 years after
silicone implant placement, and every 2 years after that, and if rupture is noted on MRI,
the implant must be removed/replaced. (Dr. DeWire's comment:
MRI exams can be expensive and are likely not going to be covered by
insurance due to the cosmetic nature of the investigation in
augmentation patients, although insurance coverage for reconstructive
patients is a possibility. Further, MRI is very sensitive in detecting
rupture, that is it will rarely miss a true rupture, but MRI is
not equally accurate, in that only about 85% of detected
"ruptures" actually represent a ruptured implant, and thus
about 15% represent false positive findings, with no actual
rupture. That is problematic in the event of reoperation for
rupture detected by MRI, and requires careful pre-operative
counseling. )
Rupture of silicone
gel-filled breast implants are most often silent (i.e., no symptoms are
experienced by the patient and no physical signs of changes with the
implant are evident most of the time)
According to the FDA, the
sensitivity of plastic surgeons familiar with implants to diagnose
rupture by physical exam alone is 30%, versus 89% by MRI scan.
(Somehow the FDA has decided that physical exam to determine rupture of
a silicone implant is not even as accurate as a coin-flip---TMD)
Breast implants may
interfere with breast feeding (Dr. DeWire's comment: this is
mainly an issue if implants are placed via a peri-areola (nipple)
incision)
With any implant, routine
screening mammography will be more difficult, and more views are needed.
(see: http://www.advanced-art.com/Breast-Aug-Over-Under.htm
and the mammography links at the bottom of that page)
Routine monthly breast
self-exam should be performed by all patients (Dr. DeWire's comment:
This is true for all women, whether or not they have implants, and I am
amazed by how many of my patients admit that they do not perform
self-exam at all, or perform it only infrequently)
According to the FDA,
changes to a patient's breasts are irreversible when implants are placed
(Dr. DeWire's comment: In my experience, this is mainly an
issue when oversized implants are used, irreversibly stretching the skin
and support tissues, or when implants have been placed over the muscle,
leading to ongoing tendency to stretch the skin, producing ptosis or sag)
According to the FDA,
patient health insurance premiums/coverage may be negatively affected by
placement of silicone implants (Dr. DeWire's comment: In my
experience this has been rare, but you should check this fact with your
insurance carrier to be sure, especially since rules are vastly different
from region to region, and from insurance plan to insurance plan--I am
not sure how this will be impacted by the Affordable Health Care Act)
According to the FDA,
patients with silicone implants should make that fact known to any
doctor who treats them, as it is an important part of medical/surgical
history
According to the FDA,
scar firmness around an implant (capsule contracture) should not be
treated by closed capsulotomy (squeezing the breast to break the scar),
as that can lead to implant damage or rupture. (I
agree with this statement---TMD)
The FDA agrees that
smoking may interfere with healing after surgery (Dr. DeWire's
comment: smoking certainly significantly increases the risk of
development of capsule contracture and unpredictably of healing, thus
potentially leading to asymmetry of breast shape and geometry, and
potentially causing the need for revision procedures.)
An FDA-approved
information brochure "Important Information for
Augmentation/Reconstruction Patients About Mentor MemoryGel™ Silicone
Gel-filled Breast Implants" (60 pages) must be reviewed and
signed by all patients who seek silicone implants and a copy of the
signed brochure must be kept in the patient records along with surgeon's
signature and attestation. This brochure reviews the Mentor Core Gel
Silicone Study, in which Dr. DeWire was a principal clinical
investigator, and which led to the FDA approval of Mentor's silicone gel
implants as both safe and effective. Risks and benefits of silicone
implants are reviewed in the brochure, as well as various obligations
and information concerning silicone gel breast implants. This
information is an important part of establishing patient understanding
of silicone implant risks and benefits, and is an important facet of
informed decision making and consent. This brochure should be downloaded
from the link above and should be read and understood well before the
consultation so that informed questions can be posed and answered at
consultation. An example of the acknowledgment of informed decision
is found via this link: Informed
Consent Acknowledgment
The FDA considers
alternatives to breast augmentation to include:
- do nothing and live
with your present status as an alternative to breast augmentation
- use saline implants as
an alternative to silicone implants
According to the FDA ,surgery should not be scheduled for at least 1-2 weeks after review of
the brochure and appropriate consultation, unless earlier surgery is
deemed necessary by the surgeon
The FDA will conduct
yearly surveys of 50 surgeons who are major users of silicone breast
Implants to assess compliance with the Informed Consent and record keeping
requirements
Implant manufacturers
will be required to maintain a registry of all patients who have opted
to have placement of silicone gel breast implants, although patients may
opt to refuse submission of personally identifiable information (name,
address, SS#). Nonetheless, the FDA strongly urges compliance by all
patients with entry into the implant registry, should they need to be
identified and supplied with any important or pertinent information in
the future.
