[Federal Register Volume 60, Number 124 (Wednesday, June 28, 1995)]
[Notices]
[Pages 33608-33609]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-15769]
[[Page 33607]]
_______________________________________________________________________
Part VI
Department of Health and Human Services
_______________________________________________________________________
Food and Drug Administration
_______________________________________________________________________
Silicone Inflatable Breast Protheses; Information for Women Considering
Saline-Filled Breast Implants; Availability; Notice
Federal Register / Vol. 60, No. 124 / Wednesday, June 28, 1995 /
Notices
[[Page 33608]]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 95N-0007]
Silicone Inflatable Breast Prostheses; Information for Women
Considering Saline-Filled Breast Implants; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a patient risk information sheet entitled ``Information
for Women Considering Saline-filled Breast Implants.'' The purpose of
this information sheet is to provide prospective patients with
information about the possible risks involved with silicone inflatable
breast prostheses (saline-filled breast implants).
ADDRESSES: Submit written requests for single copies of the information
sheet entitled ``Information for Women Considering Saline-filled Breast
Implants'' to the Center for Devices and Radiological Health, Division
of Small Manufacturers Assistance (HFZ-220), 1350 Piccard Dr.,
Rockville, MD 20850. Requests should be identified with the docket
number found in brackets in the heading of this document. Send two
self-addressed adhesive labels to assist that office in processing your
requests, or FAX your request to 301-443-8818. ``Information for Women
Considering Saline-filled Breast Implants'' is available for public
examination in the Dockets Management Branch (HFA-305), Food and Drug
Administration, rm. 1-23, 12420 Parklawn Dr., Rockville, MD 20857,
between 9 a.m. and 4 p.m., Monday through Friday.
FOR FURTHER INFORMATION CONTACT: Rosa M. Gilmore, Center for Devices
and Radiological Health, Office of Standards and Regulations (HFZ-84),
2094 Gaither Rd., Rockville, MD 20850, 301-594-4765.
SUPPLEMENTARY INFORMATION: Saline-filled breast implants were already
on the market when FDA was given the authority to regulate medical
devices. After passage of the Medical Device Amendments of 1976, FDA
classified this device into class III (premarket approval). Under a
``grandfather'' clause, manufacturers were permitted to continue
marketing class III devices already on the market, with the
understanding that at some time in the future FDA would require them to
submit preclinical and clinical data showing that their devices are
both safe and effective. FDA believes that it is important for
prospective recipients of saline-filled breast implants to know that
FDA has not yet seen or evaluated preclinical information and clinical
trials on these devices. The agency believes that patients should
receive information about the possible risks involved before surgery so
that they have an opportunity to review the material and discuss it
with their doctor. Each woman must decide with her doctor whether she
is willing to accept the risks in order to achieve the expected
benefits. FDA believes that this decision should be an informed one.
FDA issued a notice to promote the dissemination of information on
risks associated with saline-filled breast implants in the Federal
Register of September 26, 1991 (56 FR 49098). FDA stated in that notice
that it would regard saline implants as misbranded under the Federal
Food, Drug, and Cosmetic Act (the act) if their labeling does not
provide adequate written information to patients on the risks
associated with these devices. Included in the Federal Register notice
was a suggested patient risk information sheet.
Subsequently, in December 1994, FDA solicited comments from health
professional groups, consumer organizations, and manufacturers on
updating the patient risk information sheet. FDA has sent the updated
risk information sheet to the two manufacturers of saline-filled breast
implants, Mentor H/S and McGhan Medical, so they can provide it to
physicians who perform breast implant surgery. It is the responsibility
of these physicians to provide the information sheet to prospective
patients before they have decided on surgery so they can read,
consider, and discuss the current information before deciding whether
to have the surgery.
To ensure that patients receive the revised patient information,
these two manufacturers have agreed to send a ``Dear Doctor'' letter to
their physician customers, including a copy of the revised patient risk
information sheet, to remind them of the importance of providing this
information to all prospective patients. Written confirmation from the
physicians that they agree to disseminate the revised patient
information will be requested. The manufacturers also agreed to ask the
American Society for Plastic and Reconstructive Surgeons to include in
their next newsletter an article advising their members of the updated
patient information, and reminding them of their responsibility to
provide this information to all prospective patients. Lastly, the
manufacturers are to ensure that all saline breast implants shipped
include the revised patient risk information sheet.
The saline-filled breast implant is currently the only device
legally available for breast augmentation. For breast reconstruction,
the current legal restrictions on the use of silicone gel-filled
implants limit their use to those cases where the saline breast
prosthesis is considered medically unsatisfactory.
Because FDA believes it is important that the information in the
patient risk information sheet is available to consumers and the
general public, FDA is providing the text of this sheet below and will
provide single copies on request to the Division of Small Manufacturers
Assistance (address above).
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 [[Page 33609]] insert for
these devices gives additional, more detailed information. Your
surgeon has a copy and can provide it to you.)
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 likely 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 implant. 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 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 below.)
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.
Unknown Risks
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 syndrome.
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.
Dated: June 15, 1995.
Joseph A. Levitt,
Deputy Director for Regulations Policy, Center for Devices and
Radiological Health.
[FR Doc. 95-15769 Filed 6-27-95; 8:45 am]
BILLING CODE 4160-01-F