Breast Implant Safety

Medically Reviewed by Stephanie S. Gardner, MD on June 06, 2024
7 min read

There are two general types of breast implants available in the U.S. -- saline and silicone gel. 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 gel breast implants are filled with silicone gel.

Silicone gel breast implants were first introduced in 1962. During the 1980s, the popularity of silicone gel breast implants surged, but so did accounts of their supposed risks. Many people claimed there was a link between ruptured silicone gel implants and a greater risk of immunological disorders (such as lupus, 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 gel breast implants to women having reconstruction after surgery for breast cancer. For the next 14 years, women who wanted breast augmentation had to use saline breast implants.

In 2006, after reviewing research and finding no connection between silicone gel implants and disease, the FDA approved the sale of certain silicone gel breast implants.

According to the current research, there aren't significant differences in the safety of silicone gel 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, a fall, or -- 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.

    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.

    Silicone gel 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 gel implant ruptures, your doctor will probably recommend removing it and any loose silicone.

    Ruptures of silicone gel breast implants are often "silent," meaning patients and doctors may not notice them. They can only be detected by MRI. For this reason, the FDA recommends that women with silicone gel 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 original 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 gel breast implants contain platinum; saline implants don't. While some people feel that platinum could be harmful, the FDA says that studies have not found that it poses any risk in breast implants.
  • Surgical differences. Saline implants are filled after they’re implanted, so saline implants require a smaller incision than pre-filled silicone gel breast implants. Also, many saline implants can be adjusted after surgery. Months later, a woman could decide to increase or decrease the size of their 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 gel 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 gel breast implants. The FDA explains that the risks are different for the two products, specifically citing the issues surrounding the removal of ruptured silicone gel breast implants.

Because the FDA has received new information about the risks of breast implants, it is recommending a boxed warning and a patient decision checklist be part of the labeling for these devices to ensure the risks are understood by patients that allows them to make a well-informed decision. 
The FDA has recommended updates to the silicone gel-filled breast implant rupture screening recommendations and provision of patient device cards. Those cards include the device’s serial or lot number, style and size, unique device identifier (UDI), and a Toll-free phone number to the breast implant manufacturer.
It is recommended that you have periodic imaging (e.g., MRI, ultrasound) of your silicone gel filled breast implants to screen for implant rupture regardless of whether your implants are for cosmetic augmentation or reconstruction. These recommendations do not replace other additional imaging that may be required depending on your medical history or circumstances (i.e., screening mammography for breast cancer).

While studies have not found evidence that breast implants, either silicone gel 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, rupture becomes more likely as breast implants age. 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. In addition, insurance rarely pays for these revision surgeries.

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.

Breast implant-associated anaplastic large cell lymphoma (BIAALCL), BIA-ALCL is a type of cancer known as non-Hodgkin’s lymphoma. The most common symptoms are persistent swelling, presence of a mass or pain in the area of the breast implant that may occur years after implant placement. An individual’s risk of developing BIA-ALCL is considered to be low. Researchers are investigating these symptoms to better understand their origins. 

Breast implant illness (BII). The term “breast implant illness” are symptoms such as fatigue, memory loss, rash, “brain fog,” and joint pain that have been reported by some women with breast implants.  At this time, it's unclear whether these symptoms are a result of the implants. 

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.

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.

Perhaps the most important thing is to develop realistic expectations. Find a doctor you really trust and can talk frankly and openly with. 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.