By Diana Zuckerman, PhD.

When Anne Stansell was diagnosed with breast cancer at the age of 39, her doctor was certain she would opt for implants. "The doctor said I needed mastectomies, radiation therapy, and breast implants, said Stansell, a real estate agent and photographer from Albuquerque, New Mexico. "Implants were just part of the treatment. There was no discussion."

Since breast reconstruction is a popular option after a mastectomy, many breast cancer patients are surprised and concerned about the controversy that has arisen concerning the procedure during the last dozen years.

The Food and Drug Administration (FDA) approved saline breast implants in 2000, but in January 2004, decided not to approve breast implants filled with silicone gel. They weren’t sure that silicone gel breast implants were safe, and wanted more research before lifting the current restrictions on their use. In late 2004, implant makers submitted more research information, and although FDA scientists expressed concerns about potential risks, the FDA once again is considering whether long-term safety questions need to be answered before making silicone implants more widely available.

The FDA’s concerns are important to every breast cancer patient. We still don’t know why breast implants break, how long they are likely to last, and what the health consequences are when silicone gel breast implants break and leak inside a woman’s body. Although there are unanswered questions about the longterm health risks of saline breast implants and concerns about how long they last, they are considered safer than silicone because when they do break, salt water leaks out instead of silicone gel.

Most breast cancer patients have a choice of whether to get a mastectomy or lumpectomy. If they choose a mastectomy and want to have reconstruction, they can choose saline breast implants, silicone breast implants, or the TRAM flap or other autologous tissue transfer – which creates a breast like shape from fat elsewhere in a woman’s body. With these choices, it’s important to understand what is known and not known about the safety of breast implants, so you can make the choice that is best for you.

Anne Stansell said that her implants were fine for the first five years after her reconstruction. "Then I became very ill," she recalled. "My implants were taken out about two years later. Half of one of my implants was gone. Where did the silicone go? I don't know."

Many women are happy with their breast implants at first, but research conducted on several hundred reconstruction patients by Dr. Krishna Clough of the Curie Institute in Paris showed that this satisfaction tends to wane over time.

In contrast, women who underwent TRAM flap breast reconstruction with their own tissue instead of implants, were more satisfied and stayed satisfied. The vast majority of breast cancer survivors will live for decades after their diagnosis, so it’s important for them to know how long the implants will last and whether additional surgery will be necessary. Unfortunately, there is considerable disagreement among experts who try to answer this question. Why don’t we know more?

The FDA requires that any new implant must be proven safe before it can be sold in the United States, but that was not always the case. Breast implants were first sold in the 1960s, at a time when there was no government regulation of medical devices, including implants. When a law was passed giving the FDA that authority in 1976, the agency was overwhelmed with an enormous backlog of medical devices that needed to be evaluated. Breast implants were not considered to be especially worrisome or important – compared to heart valves or shunts for example — so they were allowed to stay on the market temporarily.

Twenty-five years passed, and in all that time, there were no published studies of women with breast implants, despite serious problems with some patients.

Finally in 1991, the FDA required the manufacturing companies to submit safety research on silicone gel breast implants for the first time. The FDA was surprised to learn that although almost one million women had breast implants, the companies had just started their clinical trials. The FDA refused to approve the implants on the basis of such skimpy research, but allowed silicone gel breast implants to be sold to any breast cancer patients who participated in ongoing clinical trials, to determine if they were safe.

Twelve years later, one of the same implant makers, Inamed, tried again, providing two years of research on breast cancer patients and three years on augmentation patients. At a public meeting held in October 2003, Inamed brought experts who testified about the safety of silicone gel implants. FDA scientists and statisticians also testified, about where they agreed or disagreed with Inamed’s conclusions.

The FDA had conducted a study that showed that most women with breast implants have at least one broken implant within 10 years, and that women with leaking silicone gel implants are more likely to suffer from a painful condition called "fibromyalgia" than women whose implants were not leaking.

Doctors, researchers, and women with implants were also allowed to testify, as were consumer groups and breast cancer organizations. Most of the plastic surgeons explained why silicone gel implants had better cosmetic results than saline implants, and some of the breast cancer survivors and advocates enthusiastically agreed.

Other breast cancer survivors, like Stansell, told frightening stories about implants that broke and leaked silicone into their bodies. Inamed pointed out that the Institute of Medicine, a wellrespected scientific group, had concluded in their 1999 report that breast implants were safe. However, according to Dr. Stuart Bondurant, who chaired the Institute of M e d i c i n e report, the report had two major p e r s p e c - tives. "We found no persuasive evidence that major systemic diseases were caused by breast implants, but we also found that the local complications are significant" he said.

Testimony by breast cancer survivors and the most recent research by FDA and other government scientists raised questions about long-term safety that could not be answered by the Institute of Medicine report or by the 2-year and 3-year studies that had been conducted by Inamed.

The chair of the FDA’s advisory panel, Dr. Thomas Whelan, said it was "mindboggling" that after so many years there was so little information about safety. Although the panel voted 9-6 in favor of approving silicone gel breast implants, they included many conditions of their approval that would have been difficult or perhaps impossible to enforce. In January 2004, the FDA decided that because of the lack of information about implant breakage, silicone implants would not be approved. The FDA advised implant companies that better safety research was needed.

In April 2005, the FDA once again convened an advisory panel to review research conducted by Inamed and another implant maker, Mentor. Inamed provided the FDA with an additional year of data on rupture and leakage, but Mentor only had 2-year and 3-year studies. This time, the advisory panel voted against approving silicone implants made by Inamed, partly because of the high rupture rate among breast cancer patients who had implants for reconstruction. The advisory panel voted in favor of approving silicone implants made by Mentor because their rupture rate seemed lower, even though their studies were shorter. Once again, the panel expressed their concerns by including many strict conditions if implants were approved, such as requiring better training of plastic surgeons who want to use the implants, and a registry so that patients can be quickly notified if problems arise. FDA needs to decide whether to follow the advice of the advisory panel; although they are not required to do so.

The situation is different for saline breast implants, which are made of a silicone outer shell that is filled with salt water. In 2000, the FDA reviewed the safety of saline breast implants for the first time.

Three companies studied local complications of breast cancer patients and augmentation patients who had implants for three years. Based on those studies, the FDA decided that the saline breast implants made by two of the companies, Inamed and Mentor, were "reasonably safe." Implants by the third company, PIP, were not approved.

However, more than half of breast cancer patients had complications with their breast implants – a very high complication rate for just three years. Some of these complications were very serious, while others were merely cosmetic. The FDA wanted to keep saline breast implants as an option, but required the implant makers to keep studying women with implants for at least seven more years.

Despite the uncertainties about breast implants, there is a lot of good news for patients. Breast cancer patients are being diagnosed earlier than ever before, and the vast majority of women with Stage 0, 1, 2 or 3a breast cancer can safely choose lumpectomy rather than mastectomy.

These patients either have a pre-cancerous condition or a relatively small, early cancer that has not spread at all or spread only to the lymph nodes under the arm. Many women who choose mastectomy can have their breast replaced with their own tissue, using a TRAM flap or other operation. This is a complicated operation which requires a very skilled and experienced surgeon, but the results are permanent and usually more natural looking than implants.

Those who choose mastectomy can choose FDA-approved saline breast implants. For breast cancer patients who are willing to participate in a study, silicone gel breast implants are still widely available. However, women considering implants should carefully read the patient brochure to learn about the likely complications, and talk to patients who have had implants for at least 10-15 years.

In the last few years, implant makers have tried to develop a safer silicone implant, using a thicker gel. It will take a few more years of research to find out if these implants do not break or leak as easily as the current silicone models.

The FDA’s decision to require better implant safety studies benefits all women with breast cancer or seeking augmentation, by setting a high standard that safeguards their health.

Diana Zuckerman Ph.D is president of the National Research Center for Women & Families. She is trained in epidemiology and psychology, and is a nationally-recognized expert on women’s health. Photo© T.J.Popkin