Safety of Breast Implants: A Mixed Message : Health: Women eligible because of cancer surgery find themselves caught in the cross-fire over the silicone devices. Some also question the FDA’s follow-up study.
Phyllis was caught in the cross-fire. In January, she had a breast removed because of cancer. During surgery, a balloon-like device called a tissue expander was inserted to prepare a space in which a surgeon could later place a silicone implant.
But during the weeks after her mastectomy, the Food and Drug Administration announced its restrictions on silicone implants, saying that their safety was not fully understood and that the use of the devices should be limited while studied further.
Phyllis, 60, could still get a silicone implant, she was told. Under the FDA restrictions, announced April 16, most mastectomy patients can receive silicone implants if they agree to enter a clinical safety study. But she wasn’t sure she wanted one.
Many patients, and their physicians, say they are confused and bothered by the FDA’s criteria for the study. They say that silicone implants--previously considered the optimal choice for breast reconstructive surgery--are no longer such a desirable alternative and that the other options aren’t so great either.
“I endured many sleepless nights and days,” the Los Angeles woman says.
Finally, Phyllis told her doctor she wanted a saline implant instead.
“At my age it didn’t matter to me that the breast was not perfect,” she says. “I didn’t think anything would really happen if I had the silicone implant, but I didn’t want to take the chance. I heard so many horror stories.”
Dr. W. Grant Stevens, chief of surgery at Daniel Freeman Marina Hospital, says that when confronted with a breast cancer diagnosis, a woman “has a number of considerations, not the least of which is her health.” Other considerations include her body image, her relationship with her spouse or partner and, now, the uncertainty over the safety of the most popular implant.
The controversy has created deep and emotional rifts between medical experts, as was apparent last week when the nation’s top medical journal, the New England Journal of Medicine, criticized the FDA’s decision.
In the past, silicone gel implants were an obvious choice for a woman who wanted reconstruction. But the FDA’s investigation of the device, spurred by consumer complaints, found that the safety of the implants has not been properly established.
Studies have shown that silicone can leak from the implants and that the devices can cause a painful hardening of the surrounding tissue. These risks have been generally known and accepted by women who have chosen the implants for reconstructive or augmentation surgery.
But experts disagree over the long-term health effects of migrating silicone in the bloodstream and whether that risk has been clearly communicated to patients.
Because the gel is soft and produces contours similar to those of breast tissue, the silicone implant is considered cosmetically superior to the saline implant, which is water-filled. Saline implants can also break, causing the breast to deflate. And the lack of safety data means that those devices, too, will come under FDA review later this year.
Another alternative for breast reconstruction is tissue flap surgery, in which a woman’s breast is remade from the skin and tissue that covers the abdominal muscles.
This surgery often produces satisfactory cosmetic results, experts say, but entails a longer and more complicated operation and recovery period. It can leave scars and should be performed only by experienced surgeons. It is also much more expensive than implants and cannot be performed on all mastectomy patients.
“The FDA decision has created a situation of more confusion for the patient,” says Dr. Scott Spear, a professor of surgery at Georgetown University Medical Center in Washington. “There is a lot of frustration right now on the part of everybody--doctors and patients.”
The implant controversy also has raised other disturbing questions:
* Is the lack of attractive and affordable options for breast reconstruction leading women who should undergo mastectomy to opt for breast-sparing surgery, in which the breast is not completely removed?
* Are some mastectomy patients delaying cancer surgery or reconstructive surgery because of the confusion?
* Is it fair to ask only breast cancer patients to assume the risk of testing silicone implants?
Surgeons say the answer to the first question won’t be clear for many months. But the lack of satisfactory alternatives to silicone implants should not influence whether a woman undergoes mastectomy or a tissue-sparing surgery, Stevens says:
“Never should the aesthetics be a priority over the treatment of the cancer.”
What is more likely, and equally bothersome, is that some patients are delaying surgery because of their indecision about reconstruction, Spear says.
Studies repeatedly show that women who opt for immediate breast reconstruction when the tumor is removed fare better emotionally than women who postpone or opt not to have reconstruction.
“Women who have immediate or simultaneous reconstruction have an improved psychosocial profile, the family members do better and the patient has better recovery period. This has been well documented in several studies,” Stevens says.
But any answers about the safety of silicone implants, he says, will probably take five years.
And mastectomy patients want to know why they have been granted the dubious privilege of being allowed to receive a medical device that the government says may not be safe.
Details of the safety study project have not been released. But FDA spokeswoman Susan Cruzan says breast cancer patients (or other women who require implants because of disease or deformity) will be registered so manufacturers can follow their cases to determine possible adverse side effects. (A limited number of women seeking implants for augmentation will be allowed to have them as part of the study.)
In an editorial in last week’s New England Journal of Medicine, Executive Editor Marcia Angell said the FDA’s stipulation “has the effect of coercing women with breast cancer to become subjects of clinical studies, since this is the only way they can receive implants after mastectomy.”
Moreover, Angell said, many women believe that the FDA’s decision to withdraw the devices from the market is official confirmation that implants are dangerous.
Marina Hospital’s Stevens thinks mastectomy patients “have been sent a mixed message. I’m concerned that the message we may be giving them is that the implants are unsafe for augmentation but are somehow all right for women who have breast cancer. Are we saying to the breast cancer patient: ‘It doesn’t matter if they are unsafe to you because you have cancer?’ Implants are either safe or unsafe. There are not two levels of safety here.”
Barbara, a 39-year-old Los Angeles woman who had a mastectomy last November, was also angered by the FDA’s requirements for the study.
“The way I read it was that, well, they are going to make this available to women who have had mastectomies because they have this great emotional need. I think some women who want augmentation have a great emotional need, too,” she says. “And why is it OK for someone like me to have this risk? I can appreciate what the FDA is doing, but it should be a woman’s choice.”
She’s also unsure about the safety of saline implants.
“I don’t know if I will ever choose to have an implant,” Barbara says.
Although the FDA may allow a small number of breast augmentation patients in the study, critics believe that by concentrating primarily on mastectomy patients, the FDA is singling out that group for the potential risks of silicone implants.
Although it’s too soon to tell, it doesn’t appear that overwhelming numbers of mastectomy patients will opt to enter the silicone study. For one thing, enrolling in the study involves extra paperwork that is burdensome to the doctor and patient.
And some women may believe that being part of a study is one question mark too many in their lives, says Selma Schimmel, founder of Vital Options, the nonprofit social services agency for cancer patients.
“You’re already part of a ‘study,’ ” she says, “just by having had cancer.”
