Silicone Breast Implants Available
Under Tight Controls
by Marian Segal

The Food and Drug Administration decided last April to allow the continued    
use of silicone gel-filled breast implants, but only under limited            
conditions. 

Any woman who needs implants for reconstruction after breast cancer surgery   
or for certain other medical conditions can get them, but the number of       
women who can have them for augmentation (breast enlargement) is limited.

Part of the reason for limiting the number of augmentation patients is that   
some of the risks of implants may be greater for these individuals, mostly    
because women who elect augmentation are generally younger and they have      
breast tissue. Younger women will be exposed to silicone for a longer time.   
Women with breast tissue should have mammograms to screen for breast cancer.  
Without special expertise, the potential for inadequate mammography can       
delay detection--and thus treatment of breast cancer--because implants can    
hide some breast tissue.

Whether for augmentation or reconstruction, the implants are available only   
through carefully controlled studies.

Announcing the decision April 16, FDA Commissioner David A. Kessler, M.D.,    
said, "The central aim of FDA's decision is to gather information and         
restrict access of silicone gel breast implants to carefully controlled       
studies."

Since breast implants first came on the market 30 years ago, an estimated 1   
million women in the United States have had these devices surgically          
inserted to enlarge or reshape their breasts, or for reconstruction           
following breast cancer surgery. Most are filled with a silicone gel; about   
10 percent contain saline (salt water). Until recently, both gel-filled and   
saline implants were available to virtually any woman who wanted them.

In recent years, however, there has been an impassioned debate on the safety  
of silicone gel-filled breast implants and whether or not the devices should  
remain on the market. Despite the controversy, there was agreement among      
manufacturers, physicians, surgeons, consumer advocates, and women with       
implants on at least one point: Solid clinical research is needed to answer   
questions that loom large regarding the safety and long-term effects of       
these devices.

In accord with recommendations of an advisory panel convened by FDA last      
February, the agency set up a system ensuring that the devices will be        
available to women who elect breast reconstruction because of cancer,         
traumatic injury to the breast, or a disease or congenital disorder causing   
a severe breast abnormality.

"While this decision is meant to be compassionate toward these patients,"     
said Kessler, "it is not to be interpreted as 'business as usual.' Our        
primary goal is to put in place a process to obtain adequate information      
about the safety of these devices."

Women desiring reconstruction can participate in "open availability"          
protocols. To be enrolled, the woman's physician will have to certify that    
saline implants are not a satisfactory alternative. These protocols will      
begin as soon as the manufacturers develop them and meet all FDA              
requirements for their conduct.

In addition, tightly controlled research, or "core" studies, will evaluate    
the known risks of the implants as well as their psychological benefits.      
Core studies will include a limited number of both reconstruction and         
augmentation patients, all of whom must meet specific criteria defined in     
the clinical protocol. Only enough women needed to answer the specific        
safety questions posed by the studies will be enrolled.

The implant manufacturers will sponsor both the core studies and the          
open-availability studies. FDA must approve the studies and protocols before  
they begin, and all patients will be required to give informed consent after  
being advised about possible risks. All patients will enroll in a patient     
registry, as well, so they will have access to information generated from     
all the studies.

The FDA decision also included a provision permitting women with an "urgent   
need" for implants to get them immediately. This included patients in the     
midst of the breast reconstruction process who had a temporary tissue         
expander in place and women who needed replacement for medical reasons such   
as implant ruptures, gel leakage, or severe hardening of the breast.

Of the women who received implants before the moratorium, 80 percent chose    
them for augmentation. Saline-filled implants are still available without     
restriction for both augmentation and reconstruction. Although the safety of  
this type of implant has not been proven, leakage or rupture would release    
only salt water, which is not harmful.

Nevertheless, like the silicone gel-filled devices, saline implants have a    
silicone rubber envelope and may not be entirely without risk. In addition,   
with leakage or rupture, saline implants deflate rapidly, requiring           
corrective surgery. FDA will soon require manufacturers of these implants to  
submit safety and effectiveness information for their products, just as was   
done for the silicone gel type.

The gel-filled implants came under scrutiny as part of an agency review of    
medical devices in use before 1976, when Congress authorized FDA to regulate  
devices. In particular, interest in the implants was spurred by reports of    
adverse effects, including:

- capsular contracture (shrinking of scar tissue around the implant that can  
cause painful hardening of the breasts)

- claims that the implants could hide some of the breast tissue, interfering  
with the ability to take and interpret quality mammograms

- questions about possible effects on the immune system due to migration of   
small quantities of silicone gel throughout the body

- concerns about cancer risk, especially in connection with                   
polyurethane-coated implants (see accompanying article, "If You Have          
Implants").

The process for reviewing breast implants was set in motion in June 1988,     
when FDA designated them class III medical devices. This classification gave  
the agency authority to ask for safety and effectiveness data after 30        
months. On April 10, 1991, the agency notified manufacturers that they must   
submit the information by July 9 or their products would be taken off the     
market.

FDA's General and Plastic Surgery Devices Panel, an outside advisory panel    
of medical and other experts, met last November to review the data            
submitted. It found the information inadequate to establish safety and        
recommended that FDA require the manufacturers to collect additional data on  
risks and benefits by a strict deadline to be set by the agency.

Nonetheless, citing a compelling public health need, particularly for         
reconstruction patients, the panel also recommended that implants remain      
available during the interim under certain conditions. These included         
requiring physicians to inform and educate prospective patients about         
potential risks and establishing a national registry to provide data on       
adverse effects.

On Jan. 6, FDA Commissioner Kessler called for a voluntary moratorium on the  
sale and use of all silicone gel-filled breast implants, pending review by    
the panel of new data not available to it at the November meeting.

FDA had obtained information that heightened the agency's concerns about how  
long the implants last in the body, how often they leak or rupture, and the   
possible harmful effects of silicone escaping into the body from gel bleed    
(leakage through the implant covering) or implant rupture. It appeared that   
the rate of rupture and the number of undiagnosed ruptures might be higher    
than earlier thought. Of particular concern was a possible connection         
between leaked silicone and connective tissue or immune-related disorders     
such as scleroderma, rheumatoid arthritis, and lupus.

At FDA's request, the advisory panel met again in mid-February to reconsider  
its previous recommendation in light of the new information, and to advise    
FDA on what counsel to give women who already have implants.

After three days of intensive hearings, the panel concluded that:
- the percentage of implants that rupture is not known, that rupture may go   
undetected in some women, and that the rupture rate may be higher than        
previously thought

implants should not be expected to last a lifetime

all implants "bleed" silicone gel through their outer envelope, and some      
percentage rupture, but that the health effects of the escaped gel are        
uncertain

there is not enough evidence to establish whether gel-filled breast implants  
can cause immune-related or connective tissue disorders--that is, whether     
women with the implants have a higher than normal incidence of these          
diseases, or whether certain groups of women may be particularly sensitive    
to these effects.

In addition, questions remained on what percentage of women experience        
capsular contracture, formation of calcium deposits in surrounding breast     
tissue, and changes in breast and nipple sensation.

Based on the findings, the panel called for tighter restrictions on the use   
of silicone gel implants.

In its April decision, the agency adopted the panel's recommendations. The    
core studies, expected to be completed in about three to five years, will     
focus on frequency of implant rupture and leakage, calcium deposits,          
frequency and severity of capsular contracture, extent of interference with   
mammography, and frequency of changes in breast or nipple sensation.

Questions about possible long-term effects such as immune-related disorders   
and cancer are under way at the University of Michigan and New York           
University. The National Cancer Institute will also sponsor a study on        
cancer risk slated to begin this year.

Other kinds of safety questions will be answered by laboratory studies        
conducted by the manufacturers under an FDA-imposed timetable. These pertain  
to the chemical composition and toxicity of the silicone material that        
"bleeds" out of the implant shell, the strength of the implant shell and its  
resistance to rupture, and the physical and chemical changes that the         
implants may undergo in the body.

If these studies establish safety and effectiveness, manufacturers will be    
able to reapply for marketing approval.

Marian Segal is a member of FDA's public affairs staff.
If You Have Implants ...

Most women with silicone gel-filled breast implants do not experience         
serious problems. If you are not having problems, there is no need to have    
your implants removed. But you should have regular checkups by a physician    
or plastic surgeon. If you have any breast discomfort, changes in size or     
shape of your breast, or any symptoms you think may be related to your        
implants, see your doctor.

Regarding specific concerns, the agency advises the following:
 You should be checked periodically by your physician for as long as you      
have implants.
 Implants can last from a very short time to many years, depending on the     
patient and the implant. In any case, they should not be expected to last a   
lifetime.
  A ruptured implant should be removed.
 The percentage of implants that rupture is not certain. An FDA advisory      
panel concluded that the rupture rate may be higher than previously thought.  
Manufacturers' reports suggest a range between 0.2 and 1.1 percent; the       
medical literature contains figures ranging between 0 and 25 percent; and     
individual doctors have said the implants fail in as many as 32 percent of    
their patients.

The panel also noted that rupture may go undetected in some patients. In      
some undetected ruptures, the gel may be contained within the fibrous tissue  
that forms around the implant. Also, the implants "bleed," or leak,           
silicone, but the significance of the leakage is uncertain.

Routine mammograms are not recommended to detect such "silent" ruptures.      
Other methods of detection, such as ultrasound, computed axial tomography     
(CAT) scans, and magnetic resonance imaging (MRI), are being studied, but     
are not now recommended on a routine basis.

The chance for rupture may increase the longer the implant is in the body.    
Injury to the breast may also increase the chance of rupture, as may          
capsular contracture (shrinking of scar tissue around the implant that makes  
the breast feel hard). Closed capsulotomy--a nonsurgical technique sometimes  
used to reduce the contracture--may also increase the likelihood of rupture.

The value of tests to detect silicone in blood and urine is uncertain.

Since small amounts of silicone "bleed" even from intact implants, these      
tests cannot tell whether your implant has ruptured. Also, silicone is found  
in many products, including commonly used medicines and cosmetics, so the     
source of silicone detected may not be clear.

If you have symptoms of connective tissue or immune-related disorders, see    
your doctor.

It is not known whether implants can cause or contribute to the development   
of connective tissue and immune-related disorders. But you should be aware    
of symptoms that can occur with these disorders. They include:
-joint pain and swelling
-skin tightness, redness or swelling
-swollen glands or lymph nodes
-unusual and unexplained fatigue
-swollen hands and feet
-unusual hair loss

People who have immune-related disorders generally have a combination of      
these and other symptoms. These symptoms can also occur with a variety of     
other health problems, however, and a doctor's evaluation can rule out other  
possible causes.

Although the possibility cannot be ruled out, there is currently no evidence  
that silicone gel-filled implants increase the risk of cancer in humans.      
Studies now under way should shed more light on this matter in the next few   
years.

About 10 percent of women have silicone gel-filled implants coated with       
polyurethane foam, intended to reduce the risk of capsular contracture.       
These implants have not been used since April 1991, because studies showed    
the polyurethane coating could break down to release very small amounts of    
TDA, a substance that can cause cancer in animals. It is not known whether    
women with this type of implant have an increased risk of cancer. However,    
based on current evidence, FDA does not recommend removing                    
polyurethane-coated implants because of cancer concerns. The agency is        
requiring the manufacturer of these implants to conduct studies analyzing     
blood, urine, and breast milk for TDA.

It is not known whether the silicone that "bleeds" from an implant gets into  
breast milk and, if so, whether it could affect a nursing child.

Research is being planned to resolve these concerns.

As is recommended for all women, you should have regular breast examinations  
by a trained health professional, and you should do monthly self-exams.

To examine your breasts, stand in front of a mirror and look for anything     
unusual, such as changes in the shape or appearance of your breasts or        
nipples. Then, with your right arm raised above your head, use the flat       
surface of your fingertips on your left hand to feel for any unusual lump,    
swelling, or mass under the skin of the right breast. Also feel for swollen   
glands or lumps in the armpit. Using your right hand, follow the same         
procedure to examine the left breast. Repeat the procedure lying down.

Pay particular attention to changes in the firmness, size or shape of the     
breasts. Also, note pain, tenderness or color changes in the breast area, or  
any discharge or unusual sensation around the nipple. Report them, or any     
other concerns about your breasts, to your doctor.

You should have screening mammography at the same intervals recommended for   
all women in your age group. Good quality mammograms are essential to detect  
cancer in any woman--with or without breast implants. (If you have had        
breast cancer surgery, ask your doctor whether mammograms are still           
necessary.) Mammography is not recommended to detect implant rupture. The     
radiation exposure to younger women is not justified for this purpose.

Mammographic examination of women with breast implants requires special       
expertise, however, because implants can often obscure breast tissue,         
impairing the ability to detect cancer. By taking extra views of the breast   
and pushing the implant backward and breast tissue forward, visibility is     
improved. Be sure the mammography facility you go to has personnel trained    
and experienced in the special techniques needed for women with implants.

Tell the radiologist and the technician that you have implants before they    
take the mammograms so they know to use special techniques and can take       
extra care when compressing the breasts to avoid rupturing the implant.

Facilities accredited by the American College of Radiology (ACR) are likely   
to have appropriately trained staff. For names and locations of               
ACR-accredited facilities, call the Cancer Information Service (toll-free     
1-800-4-CANCER) or your local American Cancer Society chapter. Then           
double-check with the facility to make sure it can perform the needed         
techniques.
--M.S.
For More Information

Additional information and support are available from:

Food and Drug Administration
For written information on breast implants. Write: FDA, Breast Implant        
Information, 5600 Fishers Lane, Rockville, MD 20857, or call (301)    
443-3170.

National Cancer Institute
For breast cancer information, including brochures, treatment information,    
and local resources. Call 1-800-4-CANCER.

Y-Me
A breast cancer support group that provides information and counseling.       
Write: 18220 Harwood Ave., Homewood, IL 60430, or call (1-800) 221-2141.

Command Trust Network, Inc.
An advocacy organization for support and information about breast implants    
and breast implant surgery. For information, send $1 and a self-addressed     
stamped envelope to P.O. Box 17082, Covington, KY 41017.

Reporting Problems

To report a problem with an implant, write to The Problem Reporting Program,  
12601 Twinbrook Parkway, Rockville, MD 20852. A copy of your report will be   
forwarded to the manufacturer and to FDA. If you have documentation you feel  
would be helpful, please enclose it with your report. Include the following   
information, if known:
-manufacturer's name
-product brand name
-style, size, and lot number
-dates of all implant surgeries
-patient's age at time of first implant
-whether the procedure was done for augmentation or reconstruction
-date of problem
-nature of problem
-time between implant and onset of symptoms
-name and address of surgeon and facility where surgery was performed
-your name, address, and telephone numbers (optional)

For information about what kind of implants you have, ask your surgeon or     
contact the facility where you had the surgery.
(quotes)

"The central aim of FDA's decision is to significantly limit the use of       
silicone gel breast implants while vigorously pursuing the necessary          
research about their safety."
--FDA Commissioner David Kessler, M.D.

The core studies will focus on frequency of implant rupture and leakage,      
calcium deposits, frequency and severity of capsular contracture, extent of   
interference with mammography, and frequency of changes in breast or nipple   
sensation.

The devices will be available to women who elect breast reconstruction        
because of cancer, traumatic injury to the breast, or a disease or            
congenital disorder causing a severe breast abnormality.

The number of women who can have breast implants for cosmetic augmentation    
is limited.