FDA Consumer Magazine - Sep - Oct 2004

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FDA CONSUMER MAGAZINE

September-October 2004 Issue

MAKING AN INFORMED DECISION ABOUT BREAST IMPLANTS

By Carol Rados

Despite more than a decade of controversy over their

safety, breast implants are more popular than ever

among women who want to build upon what nature

gave them or who want to restore what disease has

taken away. Whatever the reason, opting for breast

implants is a personal decision that should be

made only after a woman fully understands and accepts

the potential risks of the devices and the importance

of follow-up evaluations with her physician.

Some people see an enormous benefit to getting

implants and are willing to accept associated risks.

They say that using breast implants to rebuild the

breast (reconstruction), or change its size and shape

(augmentation), significantly improves the quality of

life for many women. Advocates of breast implants also

say that a woman's consent to the surgery should be

considered valid as long as she weighs the risks and

benefits of the procedure.

While every surgical procedure has potential risks,

such as infection, bleeding, and scarring, there are

risks that are specific to breast implants. Learning

about them is key to being properly informed about the

procedure.

A PRIMER ON BREAST IMPLANTS

According to the American Society of Plastic Surgeons

(ASPS), there were nearly 255,000 breast enhancement

implant surgeries in 2003, nearly twice the number

done in 1998. Another 68,000 women received breast

implants for reconstruction following mastectomy due

to cancer or other disease.

But also in 2003, 45,000 augmentation patients and

17,000 reconstruction patients had their breast

implants removed. The medical community and others,

including the Food and Drug Administration, would like

to better understand why.

Breast implants are designed for augmentation, a

cosmetic procedure; reconstruction; and replacement of

existing implants, called revision. There are two

primary types: saline-filled and silicone gel-filled.

Depending on the type of implant, the shell is either

pre-filled with a fixed volume of solution or filled

through a valve during the surgery to the desired

size. Some allow for adjustments of the filler volume

after surgery. Breast implants vary in shape, size,

and shell texture.

At this time, there are two manufacturers with

approved saline-filled breast implants. No

manufacturer has yet received FDA approval to market a

silicone gel-filled breast implant.

THE SILICONE CONTROVERSY

Breast implants were first marketed in the early

1960s, before the 1976 Medical Device Amendments to

the Federal Food, Drug, and Cosmetic Act required a

reasonable assurance of safety and effectiveness to be

shown for certain medical devices. The 1976 law gave

the FDA authority over such devices, but breast

implants were " grandfathered " into the regulatory

scheme, meaning that manufacturers were not required

to provide the agency with scientific evidence of

product safety unless questions arose about the

safety and effectiveness of these already-marketed

devices. Silicone was initially assumed by

manufacturers to be biologically inactive and,

therefore, to have no harmful effects.

But over the years, questions did arise about the

effects of silicone on the body. In 1991, the FDA

published a regulation that required manufacturers of

silicone gel-filled breast implants to submit

premarket approval applications (PMAs). This

requirement meant that the FDA needed to agree that

the manufacturer has presented data showing a

reasonable assurance of safety and effectiveness in

order for the devices to remain on the market.

In January 1992, the FDA called for a voluntary

moratorium--a delay on the use of these

implants--until new safety information could be

thoroughly reviewed. The moratorium was not intended

to " ban " the implants, but instead to allow time to

review the new safety information.

In April 1992, the agency decided that no PMA yet

submitted contained sufficient safety and

effectiveness data to support approval. However,

access to these silicone gel-filled breast implants

would continue for women enrolled in certain clinical

studies.

In the years that followed that decision, thousands of

women filed lawsuits against the manufacturers of

silicone gel-filled implants, claiming the devices had

caused serious ailments, such as connective tissue

diseases, neurological diseases, and cancer. Consumer

groups repeatedly filed petitions urging more studies

on the implants. But many women said they were pleased

with their implants, including cancer patients who had

pleaded for the opportunity to choose silicone

gel-filled implants for reconstruction.

A TURN OF EVENTS

In October 2003, the FDA held a two-day advisory panel

meeting to discuss a manufacturer's PMA for a silicone

gel-filled breast implant. Some people complained that

the meeting was premature in light of the fact that

long-term studies had not been completed, but the FDA

proceeded because the agency was required by law to

consider the pending PMA within a specified time

frame. The meeting also provided patients and others

with timely access to information and expert analyses

on the issue. The issues before the panel reflected

much of the decades-long debate over the implants.

Moreover, the meeting provided a valuable public forum

for discussing the issue from many diverse

perspectives and for raising important additional

questions.

As a panel member, O. , M.D., voted

with the majority to recommend that the FDA approve

the new PMA, but only with specific conditions.

says he wants to avoid getting into the

business of determining how a woman defines the value

of breast reconstruction or augmentation.

" The use of implants and augmentation conjures up some

social judgments that may well be unfair, " says

, a professor of surgery and director of the

University of Washington's Breast Health Center.

Rather than deciding that no woman can have access to

silicone gel-filled implants because a small number

may be at risk for certain illnesses, he says, " I

believe the better approach is to make the devices

available and inform all women of the degree of risk

involved. "

That, according to , " is reasonable informed

consent. "

In January 2004--contrary to the recommendation of the

agency's advisory panel--the FDA determined that the

new silicone gel-filled breast implant PMA was " not

approvable " at that time. This meant that the implants

were not approved for marketing pending additional

information, but that women would continue to have

limited access to them by enrolling in clinical

studies.

" The public scientific process that has been used to

consider these devices is fully consistent with the

FDA's mission--to use the best available science to

protect and promote the public health interests of the

American people, " says Kahan, deputy director of

the FDA's Center for Devices and Radiological Health

(CDRH).

Also in January 2004, the agency released a draft of

its new guidelines for companies submitting breast

implant PMAs, explaining the scientific issues that

the FDA recommends be addressed as part of their

applications. The guidance document reflects the FDA's

current thinking about new scientific information that

the agency, manufacturers, and the clinical community

have gained over the last 10 years, including

information learned at the October 2003 advisory panel

meeting. Consistent with the FDA's good guidance

practices, the agency has asked for public comments on

the breast implant guidance. The guidance is not

intended for implementation until it is

finalized.

" Current testing doesn't reflect reality, " says

A. Choti, M.D., an associate professor of

surgery and oncology at the s Hopkins University

School of Medicine in Baltimore, and also an FDA

advisory panel member. The implants, he says, are

extremely durable when tested outside the body. " You

can virtually run a truck over them and they'll hold

up. But the question is, what happens when implanted

long-term in a woman's body? "

The FDA's draft guidance document says that two to

three years of follow-up data may not be enough to

allow the agency to evaluate the safety and

effectiveness of breast implants. The agency

recommends the use of tests that can predict clinical

outcomes, such as how long breast implants will

last before rupturing in the body, as well as tests

that explain how and why the breast implants rupture.

In addition, the agency recommends that more data be

gathered regarding the rate of rupture over time, as

well as the health consequences of rupture.

BREAST IMPLANT RISKS

In 1999, the Institute of Medicine (IOM) issued a

report on a review of information related to health

effects associated with silicone breast implants, both

gel-filled and saline-filled, in humans. An important

goal of the IOM was to provide women with detailed

information about the potential risks of silicone

breast implants.

One risk is capsular contracture, which is a

tightening and squeezing of the scar tissue that

naturally forms around the implant. This contracture

may result in hardening of the breast tissue, rippling

of the skin, and changes in breast shape. It also may

cause pain, which, if severe, can require

surgery to remove the scar tissue or replace the

implant.

In addition, a rupture can occur at any time. While

saline-filled breast implants leak only salt water

when they rupture, the health effects of leaking

silicone gel-filled implants remain controversial.

Women sense a change more easily when saline-filled

breast implants rupture. But the silicone gel-filled

implants are more likely to maintain their shape after

they rupture, which can make it more difficult to

detect a break.

Called " silent ruptures, " these breaks involving

silicone gel implants may occur without a visible

change. And a woman may not feel any sensation, says

Sahar M. Dawisha, M.D., a medical officer in CDRH who

has reviewed data submitted by implant manufacturers.

Magnetic resonance imaging (MRI) with equipment

specifically designed for imaging the breast may be

used for evaluating women with suspected rupture of

their silicone gel-filled implant. The FDA considers

MRI to be the best method at this time. There are no

standards on how often to screen for silent rupture

with MRI, and the costs of this procedure must be

considered when choosing a silicone gel-filled breast

implant. Physicians usually recommend removal of the

implant if it has ruptured, regardless of whether it

is saline-filled or silicone gel-filled.

Another potential complication of implant surgery is

nerve damage, which can cause some women to experience

a loss or increase in sensation in their nipples and

breast tissue. These symptoms may disappear

eventually, but can be permanent in some cases. It is

unclear at this time whether insufficient milk

production to breast-feed--another reported

problem--is due to damaged nerves or to other reasons.

Women should know that, regardless of the type of

implant, it is likely they will need to have one or

more additional surgeries (reoperations) over the

course of their lives, because of complications from

breast implants. Reasons for reoperations include any

of the potential complications, such as capsular

contracture, wrinkling, asymmetry, rupture, or implant

malposition.

The IOM committee also found that women with silicone

breast implants are no more likely than women without

implants to develop the life-threatening systemic

illnesses that some people have claimed might be

related to the implants. But many women disagree. They

have reported health problems related to their

immune systems or neurological symptoms that they

believe are caused by ruptured or intact breast

implants. And some women who have received breast

implants claim they weren't fully informed of the

risks.

Lynda Roth, who was diagnosed with breast cancer in

1990, says she was forced to make a quick decision,

based on very little information, about getting breast

implants following a mastectomy.

" I trusted what my highly respected doctors were

telling me was true, " says the 63-year-old social

worker in central Colorado. " You're in shock, you

think you're going to die, so what kind of informed

decision can you possibly make about what you want

your breasts to look like if you're lucky enough to

survive? "

Roth did survive--both breast cancer and two silicone

breast implants gone bad. But the ruptured devices,

she believes, caused her to lose her good health, her

job, and eventually her health insurance over the next

11 years. " I found out the hard way, " she says. " There

were many risks with the implants that I didn't know

about. "

Other women are pleased with their implants. Clara

Filion underwent reconstruction in 1993 after having a

breast removal that included the lymph nodes under the

arm (modified radical mastectomy) due to cancer. The

67-year-old Bedias, Texas, resident says she's

thrilled with the outcome of her saline-filled

implant, as well as with her surgeon, even though her

original implant will need replacing soon due to scar

tissue--a local complication that Filion says she

always knew could occur. Filion has experienced no

other complications related to the implant in 11

years.

OTHER CONSIDERATIONS

" My doctor told me that these implants would go with

me to my grave, " says 44-year-old Patty Faussett of

, Nev., who chose to augment her breasts with

saline breast implants in 1997, after years of

breast-feeding distorted their shape.

Faussett had her implants removed a year after

implantation because she believes they caused a mixed

bag of health problems, including disturbed vision,

heart palpitations, muscle twitching, and an

autoimmune thyroid disease. She says, " The risks were

much greater than my surgeon led me to believe. "

Experts caution that breast implants do not last a

lifetime. Women should be prepared for long-term

follow-up and additional surgeries to treat

complications. They also should be prepared for the

accompanying additional costs. One of the biggest

problems Faussett says she hears from women in her

breast implant support group is that " most don't plan

for the money it takes to fix what goes wrong. "

In addition, women should be aware that hard pressure

on the breast (compression) during mammography may

cause implant rupture. Breast implants also can

interfere with finding breast cancer during

mammography. Doctors say the implant can hide breast

tissue and, as a result, hide lesions as

well. Extensive scarring and calcium deposits in

tissue surrounding an implant can mimic the appearance

of cancer, making the deposits difficult to

distinguish from tumors on a mammogram.

Another consideration is the choice of a surgeon.

Patient advocates, professional groups, and others

agree that it's important to choose a plastic surgeon

who has been trained in breast implant surgery and who

has performed it successfully on many women.

After switching to a new, firmer silicone gel-filled

implant through a clinical study only a year after

experiencing rippling with her saline implants, Kathy

Bracy says it's important that women who are

considering breast implants do their homework.

" I love my breast implants, but I also spent six

months researching the devices, which included picking

the best doctor for me, " says Bracy, a 38-year-old

self-employed bookkeeper from Tampa, Fla. " It's not

necessarily the product, but who is doing the

surgery. " The key to breast implant satisfaction, she

says, is to " find a doctor who is willing to answer

all your questions and take all your concerns

seriously. And the relationship with your doctor

doesn't end after the surgery. "

Experts also advise women to have realistic

expectations about breast implants. There is no

guarantee that the results will match those of other

women. Overall health, age, chest structure, the shape

and position of the breast and nipple, skin texture,

the tendency to bleed, prior breast surgeries, and the

surgical team's skill and experience all figure into

the outcome of breast implant surgeries.

THE TEEN SCENE

In addition to safety issues, there is concern about

the growing use of breast implants among teen-agers.

Health officials worry that teen-agers and their

parents may not realize the relative permanence of the

changes caused by the devices. They also want to be

sure that teens are physically ready--that is, they're

finished developing--and that they are psychologically

mature enough to handle the outcome of surgery.

" I didn't know my breasts were still growing when I

signed up for the surgery, " admits Kacey Long, who got

saline-filled breast implants in July 2001, when she

was 19. Prior to her surgery, the college student from

Ennis, Texas, was a 34B--a breast size she thought

would be with her for life.

Teen-agers who are dissatisfied with their bodies see

breast implants as a harmless--and, according to Long,

" fun " --thing to do to improve their self-image. Long

says she felt that her body was too " bottom heavy " for

her breasts and wanted to " even out " her figure. " But

I never thought about my implants being dangerous, "

she says. A friend's mother worked for a plastic

surgeon for 12 years and told Long she knew of no

problems with patients who had gotten the implants. " I

really thought that I had inside information, and that

these devices were completely safe and

maintenance-free. "

Following implantation, Long went to a 34D. But

complications convinced her to have the implants

removed a short time later. " I had shooting pains in

my arms, excruciating pain in every joint, bone, and

muscle of my body, I was exhausted all the time, had

no energy, lost my hair, and had pains in my chest,

heart, and ribs. I had trouble remembering things and

thinking clearly, and the list goes on, " she says.

" Before the implants, all I had was allergies. "

Many of the changes to the breast that occur with an

implant cannot be undone. If a teen chooses to have

her implants removed, she may experience dimpling,

puckering, wrinkling, or other cosmetic changes.

Three years later, Long's breasts measure 36C--one

size larger than before she was implanted--suggesting

that her own breasts continued to develop even after

the implants were removed. " When you're making a

decision that can impact your life at 19, " Long

advises other young women, " you need to research the

subject like you're 50 years old. "

Ongoing clinical studies for unapproved saline-filled

and silicone gel-filled breast implants do not allow

for those younger than 18 to receive the implants for

augmentation purposes. Some of these clinical studies

even limit reconstruction and revision uses to women

18 and over.

Consumers can get a copy of the " FDA Breast Implant

Consumer Handbook 2004, " which provides in-depth

information on both saline and silicone breast

implants, by visiting w.fda.gov/cdrh/breastimplants/,

or by writing to: FDA, Office of Device Evaluation,

Division of General, Restorative, and Neurological

Devices, 9200 Corporate Blvd., HFZ-410, Rockville, MD

20850.

ADDITIONAL INFORMATION ABOUT BREAST IMPLANTS

The web version of the FDA Breast Implant Consumer

Handbook - 2004 was modified to remove all resource

group information other than the FDA Consumer Affairs

Staff information. There is now a separate link to

this information on Breast Implant Resource Groups at

http://www.fda.gov/cdrh/breastimplants/addsources.html

FREQUENTLY ASKED QUESTION AND ANSWER

Question: I'm currently a 19 year old female

considering breast implants (saline). I was just

wondering if it is safe to do it at such a young age?

Answer: You have to be 18 years of age to receive

breast implants, unless you have a breast deformity

and your physician says you should have them for

psychological reasons. You should discuss this with

your physician. At age 19 it is very possible that

your breasts will get larger as you age. As with any

surgery, there are risks associated with breast

implants. I encourage you to read the " Breast Implant

Risk Brochure " and the " FDA Breast Implant Consumer

Handbook - 2004. " The website is below:

http://www.fda.gov/CDRH/breastimplants/

ADVERSE EVENT REPORTS

To do a search and get information from the Adverse

Event Reports, please go to the following websites and

use the following product codes listed below:

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/search.CFM

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmdr/search.CFM

Product codes

FTR: prosthesis, breast, non-inflatable, internal

silicone gel filled FWM: prosthesis, breast

inflatable, internal, saline LCJ: expander, skin,

inflatable MRD: sizer MWZ: expander

RESOURCES

Breast Implant Website

The breast implant website is a valuable source of

information on implant

procedures, special surgical concerns, post-operative

care, and topics to

discuss with your surgeon that can help you make your

decision. The breast

implant website also includes the breast implant

consumer handbook and

patient labeling for the approved Mentor and INAMED

saline-filled breast

implant products. Please go to the breast implant

website at:

www.FDA.gov/CDRH/breastimplants/

MedWatch

MedWatch is FDA's program for reporting serious

reactions and problems with

medical products, such as drugs and medical devices.

To access the MedWatch

website please go to:

http://www.fda.gov/medwatch

Breast Implant Listserv

If you would like to join or leave the Breast Implant

Listserv, please go

to:

http://list.nih.gov/cgi-bin/wa?SUBED1=breast-implants & A=1