How Safe Are Breast Implants?

Breast Implant Safety

For women looking into breast implants, either for reconstruction after surgery or for breast enlargement, here’s a rundown of the latest information about breast implant safety and risks.

Breast Implants: The Basics
There are two general types of breast implants available in the U.S.: saline and silicone. Both consist of a silicone outer shell; the difference is what’s inside the implants. Saline implants are filled with saline, or sterile saltwater. Silicone breast implants are filled with silicone gel. The FDA has given approval to two companies to make both types of implants, Mentor and Allergan.

While other varieties of implant are being studied -- like the cohesive silicone “gummy bear” implant – other implants haven’t been approved by the FDA and are only available to women who enroll in a clinical trial.

Silicone Breast Implants: What Happened?
Silicone breast implants have attracted a lot of controversy since they were first introduced in 1962. Back then, the FDA did not evaluate medical devices for safety.

During the 1980s, the popularity of silicone breast implants surged, but so did accounts of their supposed risks. Many people claimed there was a link between the silicone gel from ruptured implants and an increased risk of immunological disorders (like lupus and rheumatoid arthritis), fibromyalgia, and other conditions. Some women reported that their symptoms went away after the implants were removed. Some filed lawsuits against implant manufacturers.

While no studies established a firm connection, the FDA looked into the issue and, in 1992, restricted the use of silicone breast implants to women having reconstruction after breast cancer surgery. For the next 14 years, women who wanted breast augmentation had to use saline breast implants.

Then, in 2006, the FDA reversed course and approved the sale of silicone breast implants. What changed? Numerous studies conducted during the 14-year moratorium found no real connection between silicone implants and disease. The implants were deemed safe and effective. However, the FDA still required that the two manufacturers conduct studies of their safety for the following 10 years to look at the long-term effects.

Breast Implant Safety: Which Is Better?
According to the current research, there aren’t significant differences in the safety of silicone and saline implants. But each type of breast implant has its pros and cons.

Ruptures. Ruptures are a risk with either kind of breast implant. Ruptures might be caused by surgical error, or a fall, or even -- very rarely -- the pressure exerted on the breast during a mammogram. But the implications of a rupture are a little different for the two types.
o Saline implant ruptures are easy to spot. The breast rapidly changes shape over days as the fluid leaks out. If a saline implant breaks, all that leaks out is saltwater. The saltwater is harmlessly absorbed into the body

Breast Implant Safety: Which Is Better?
o Silicone implant ruptures are more difficult to notice. When the implant breaks, the leaking silicone stays in the body. It can sometimes spread outside the breast and into distant lymph nodes. As unnerving as that sounds, studies haven’t found that this results in any increased risk of disease. Nonetheless, if a silicone implant ruptures, your doctor will probably recommend removing it and any loose silicone.

Ruptures of silicone breast implants are often “silent” -- patients and doctors may not notice them. They can only be detected by MRI. For this reason, the FDA recommends that women with silicone implants get an MRI three years after implantation and once every two years after that. MRIs may not be covered by your insurance. Over the course of a woman’s life, these MRIs may cost more than the implant surgery.

Aesthetic results. Many women and plastic surgeons prefer the look and feel of silicone breast implants. Silicone breast implants are generally considered to be more like real breast tissue. Saline implants are more prone to causing rippling of the skin.
Platinum. Silicone breast implants contain platinum, while saline implants don’t. While some people feel that platinum could be harmful, the FDA says that studies have not found that the platinum in breast implants poses any risk.

Surgical differences. Saline implants are filled after they’re implanted, so saline implants require a smaller incision than pre-filled silicone breast implants. Also, many saline implants can be adjusted after surgery. Months later, a woman could decide to increase or decrease the size of her saline implants without surgery. The doctor can just use a syringe to put in more liquid or take it out. The size of standard prefilled silicone implants cannot be changed.

Eligibility. There are some differences in who can get the two types of implants. For reconstruction, women can get either type of breast implant at any age. But for augmentation, saline implants are approved for women 18 and older, while only women who are 22 and older can get silicone breast implants. Why the four year age difference? The FDA explains that “the risks are different for the two products,” and specifically cites the issues surrounding the removal of ruptured silicone breast implants.
Keep in mind that your doctor may have a strong recommendation for one type of breast implant over another. Certain things, like your body type or the current size of your breasts, might make one type of implant better for you.

Breast Implant Safety: What Are the Risks?
While studies have not found evidence that breast implants, either silicone or saline, are connected with serious disease, there are still risks. There are also long-term implications. Here are some of the breast implant safety issues that you need to consider.

The need for further surgeries. Over time, breast implants wear out and need to be replaced. How long do breast implants last? There’s no definitive answer. In general, the older the breast implant, the higher the risk of rupture. The FDA estimates that breast implants should last at least ten years. Studies have shown that some breast implants last much longer than that, and others much less.

Rupture isn’t the only problem that requires surgery. Over time, breast implants can change shape. One breast might start to look very different from the other. Sometimes, the tissue around the implant hardens, a condition called capsular contracture. Surgery is the only way to fix capsular contracture.

If you get breast implants and want to maintain your breast size and shape for the rest of your life, you should be prepared to have a number of additional surgeries. The surgery to replace an implant is not as involved as the original procedure. However, the risk of complications is actually higher.

Irreversibility. Breast implants may permanently alter your breast tissue. If you decide to have the implants removed, your breasts may not return to the shape they had before the surgery. Your breasts may stay dimpled or wrinkled.

Changes in appearance and sensation. Breast implants can cause a loss of sensation in the breast and nipple, as well as pain. They can sometimes result in excessive scarring and wrinkling.
Associated health problems. Some studies have found associations between breast implants and certain health conditions. Disturbingly, several studies have found an increased risk of alcoholism, drug abuse, and suicide in women with breast implants. However, experts generally don’t think that the breast implants are the cause of these problems. Instead, they suspect that a small minority of women who get breast implants also have underlying psychological problems that can lead to substance abuse or suicide. If you’re concerned, discuss the issue with your doctor.

Surgical complications. Like any surgery, getting breast implants poses risks. Some women have surgical infections, bleeding, and swelling.
Other issues. Some studies suggest that breast implants can make breastfeeding more difficult or impossible. They may prevent a woman from producing milk. Breast implants can also interfere with the accuracy of mammograms that screen for breast cancer.

Breast Implant Safety: Making the Choice
Deciding whether or not to get breast implants -- either for reconstruction or augmentation -- is not easy. There are a lot of things you have to weigh.

Keep in mind that studies show that most of the 300,000 women who get breast implants each year are satisfied with them. While many women are still concerned about long-term health risks, research has generally not found an association between breast implants and serious disease.

Still, getting breast implants is an involved procedure. It may commit you to further surgeries in the future. Long-term studies of breast implant safety are still ongoing. With any elective surgery -- a surgery that isn’t medically necessary -- it’s important to be especially careful.

Perhaps the most important thing is to develop realistic expectations. Find a doctor whom you really trust and talk frankly and openly. Make sure that you understand the risks of breast implants. Make sure you understand the best and worst case scenarios. The more you know, the more confident you’ll feel in your decision.

SOURCES:

The American Society for Aesthetic Plastic Surgery (ASAPS) and the American Society of Plastic Surgeons (ASPS) Breast Implant Safety web site: “What is Saline?”

American Society of Plastic Surgeons web site: “Breast Augmentation.”

Araco, A. Aesthetic Plastic Surgery, 2007; vol 31: pp 532-539.

Brown, S. American Journal of Roentgenology, October 2000; vol 175: pp 1057-1064.

Crerand, C. Plastic Surgical Nursing, July-September 2007; vol 27: pp 146-154.

Fryzek, J. Aesthetic Plastic Surgery, May 2007; vol 17: pp 374-379.

Holmich, L. Archives of Surgery, July 2003; vol 138: pp 801-806.

Sarwer, D. American Journal of Psychiatry, July 2007; vol 164: pp 1006-1013.

FDA web site: “Breast Implant Questions and Answers.”

WebMD Medical News: “Breast Implant/Suicide Link Confirmed.”

WebMD Medical Reference: “Breast Enlargement.”

WebMD Medical News: “Silicone Breast Implants Get FDA Nod.”

WebMD Medical Reference: “Breast Augmentation.”