Should You, Or Shouldn't You?
Source: FDA
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 con sent 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 ill 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, Benjamin O. Anderson, M.D., voted with the majority to recommend that the FDA approve the new PMA, but only with specific conditions. Anderson 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 Anderson, 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 Anderson, "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 Linda 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 Michael A. Choti, M.D., all associate professor of surgery and oncology at the Johns 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 Henderson, Nev., who chose to augment her breasts with saline breast implants in 1997, after years of breastfeeding 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 www.4woman.gov (800) 994-9662
Institute of Medicine www.iom.edu
National Cancer Institute www.nci.nih.gov (800) 422-6237
Office of Research on Women's Health www4.od.nih.gov/orwh/
American Society of Plastic Surgeons www.plasticsurgery.org (888) 475-2784
American Society for Aesthetic Plastic Surgery www.surgery.org (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