Article in FDA Consumer Magazine

[Guest guest]

Hi everyone,

I am really proud of this article, as the FDA addresses some of our

concerns with saline breast implants. I am mentioned in this

article, as well as the lovely Patty Fausett! She had a BEAUTIFUL

picture in this magazine as well! Thanks for doing this Patty!

Love,

Kacey

http://www.fda.gov/fdac/features/2004/504_implants.html

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

www.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.

For More Information

Food and Drug Administration

www.fda.gov/cdrh/breastimplants/

FDA Center for Devices and Radiological Health

Consumer Affairs Staff

(800) 638-2041

National Women's Health Information Center

(800) 994-9662

Institute of Medicine

National Cancer Institute

(800) 422-6237

Office of Research on Women's Health

American Society of Plastic Surgeons

(888) 475-2784

American Society for Aesthetic Plastic Surgery

(888) 272-7711

Questions to Ask a Surgeon About Breast Augmentation

What are the risks and complications associated with having breast

implants?

How many additional implant-related operations can I expect over my

lifetime?

How will my breasts look if I choose to have the implants removed

without replacement?

What shape, size, surface texturing, incision site, and placement

site is recommended for me?

How will my ability to breast-feed be affected?

How can I expect my implanted breasts to look over time?

How can I expect my implanted breasts to look after pregnancy? After

breast-feeding?

What are my options if I am dissatisfied with the cosmetic outcome

of my implanted breasts?

What alternate procedures or products are available if I choose not

to have breast implants?

Do you have before-and-after photos I can look at for each procedure

and what results are reasonable for me?

Source: FDA

Questions to Ask a Surgeon About Breast Reconstruction

What are all my options for breast reconstruction?

What are the risks and complications of each type of breast

reconstruction surgery and how common are they?

What if my cancer recurs or occurs in the other breast?

Will reconstruction interfere with my cancer treatment?

How many steps are there in each procedure? What are they?

How much experience do you have with each procedure?

What is the estimated total cost of each procedure?

How long will it take to complete my reconstruction?

Do you have before-and-after photos I can look at for each procedure

and what results are reasonable for me?

What will my scars look like?

What kind of changes in my reconstructed breast can I expect over

time?

What kind of changes in my implanted breast can I expect with

pregnancy?

What are my options if I am dissatisfied with the cosmetic outcome

of my implanted breast?

How much pain or discomfort will I feel and for how long?

How long will I be in the hospital? Will I need blood transfusions,

and can I donate my own blood?

When will I be able to resume my normal activities?

Source: FDA