[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]]

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Part VI





Department of Health and Human Services





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Food and Drug Administration



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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.

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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