FAQs

Q: Are Breast Implants Approved by the FDA?

In November 2006, after a 14-year ban on their sale due to safety concerns, FDA approved silicone breast implants. Over that time period, no convincing evidence emerged to prove conclusively that silicone implants were safe. But neither were they proved harmful, which cleared the way for their return to the market.

At the time of approval, however, the FDA announced that it would conduct a study of 80,000 women over 10 years to determine the safety of silicone implants once and for all, an acknowledgment that the agency needed to gather more information about their long-term impact on women’s health. In the meantime, potential recipients would be free to use their judgment and get them if they wish.

FDA approved saline implants in 2000, after a review process that looked at two-years worth of data for a device that resides in women’s bodies for decades.

In 2003, the head of the FDA’s Center for Devices and Radiological Health, Dr. David Feigal, said in relation to implants: People have the misconception that an FDA-approved product is safe, but, actually, the agency evaluates products to see if risks outweigh benefits and then it’s up to “the consumer to decide whether or not they’re willing to take those risks.” And further back in 2000, in a press release announcing FDA approval of saline implants, Dr. Feigal said, “It’s clear from these studies that there is a possibility that a substantial number of women who get these implants will require additional surgery at some point to remove or replace their implants because of complications.”

So, yes, both saline and silicone implants have FDA approval, but this should not be interpreted as an endorsement of safety. It is the responsibility of women considering implant surgery to assess the available safety information before going through with the procedure.


Q: Are Implants Safe?

Some studies released in the 1990s raised questions about the links between silicone breast implants and systemic health problems. To date, those links have not been conclusively established or dismissed because almost no research has been done on the health effects of saline and silicone breast implants that have been in the body beyond five years.

Though many researchers believe the long-term health risks are still unknown, local complications from implant surgery are recognized and well documented. Studies have shown that within the first three years of getting implants for the first time, almost half of the women experience one local complication such as pain, infection, hardening or the need for additional surgery. This number soars to about 75 percent among breast cancer patients.

An FDA team reported in 2001 that women with ruptured silicone implants are significantly more likely to be diagnosed with fibromyalgia and other illnesses. A 2001 National Institutes of Health study shows a 21 percent overall increase in cancers for women with silicone breast implants compared to the general population, and the incidence of leukemia and stomach, cervical, vulvar and brain cancers twice as high for women with implants.


Q: How Much Do Breast Implants Cost?

Women considering implant surgery must look at costs beyond the initial procedure.

The price of breast augmentation surgery costs about $6,000. When the FDA approved silicone gel breast implants in November 2006, it stated that women with these implants should have a breast MRI three years after getting silicone implants and every two years after that. MRI exams cost about $2,000 each visit. Because almost half of silicone implants rupture by 10 years, they need to be replaced every seven years or so. A woman in her twenties getting her first implants is looking at perhaps an additional seven surgeries over the course of her lifetime and about 25 MRI screenings. This is a financial investment of at least $99,000, but likely more since replacement surgery is often more expensive.

Potential implant recipients must also keep in mind that cosmetic implant surgery is not covered by insurance, and treatment for complications from implants may not be covered either. In fact, once a woman becomes an implant recipient, her overall health coverage may change drastically: premiums may rise, and future coverage may be denied for breast cancer or other illnesses. It is critical for women to contact their insurance providers before undergoing the implant procedure to understand how implant surgery could impact their health coverage.


Q: How Long Will My Implants Last?

Implants do not last a lifetime and may not even last as long as a new car.

One study found that nearly half of silicone implants fail within ten years and three-quarters of silicone implants rupture by twenty years. An FDA study of silicone implants found that most women had at least one broken implant after 15 years, and silicone had migrated outside the breast capsule in 21 percent of the women who agreed to MRI screening.

Saline implant failure is less of a health concern because saline implants deflate quickly, enabling immediate diagnoses and treatment, and the body easily absorbs the saline leakage. Saline implants, however, are encased in silicone shells, and silicone has been found outside the breast capsule in women with saline implants as well.

Women who receive implants must be prepared to have replacement surgery every seven to ten years.


Q: Are Saline Implants Safer than Silicone Implants?

Saline implants carry many of the same risks as silicone implants, so it is impossible to judge which is safer. The Food and Drug Administration warns that, “like their silicone counterparts, saline breast implants can rupture, ripple, harden, change shape and shift position. They can also cause infection, pain and loss of feeling in the nipple or tissue of the breast. And they can interfere with breast-feeding and the detection of breast cancer.”


Q: What Are Some Breast Implant Complications?

There is widespread agreement that local complications are the greatest concern in breast implant surgery because they are common. In fact, the FDA warns prospective implant patients: “Either because of rupture or other complications, you will probably need to have the implants removed,” and “you are likely to need additional doctor visits, re-operations, or removals because of one or more complications over the course of your life.”

The most common complication is capsular contracture, when the breast becomes painfully tight and hard. Capsular contraction may require surgical treatment. It may cause movement of the implant, which is often disfiguring. Other common problems of silicone or saline implants include loss of nipple sensation, breast pain and rashes.

Women thinking of silicone implants should be aware that silicone has been known to migrate away from the breast, and there have been cases where the substance has been removed from joints and internal organs such as the uterus, ovaries and liver. Women thinking of saline breast implants should be aware of the risk of infection from bacteria, mold, or fungus growing in the salt solution.


Q: Why Does My Doctor Seem to Downplay the Risks of Breast Augmentation?

We trust our doctors to stay on top of the latest developments in medicine. It’s hard, however, to expect them to go beyond the body of research that’s readily available, and what is now available does not prove that implants pose an unacceptably high risk to a woman’s health. The available research is faulty in that it heavily focuses on women who had implants for less than five years. More research is necessary in order for doctors to be able to assess the long-term effects of this medical device that resides in women’s bodies for decades.

Doctors who perform cosmetic breast implant surgery are also very motivated to grow this part of their practice. Cosmetic breast augmentation procedures are not covered by insurance, so recipients must pay out-of-pocket. This saves medical offices the time and resources they must devote to handling insurance claims. It also means that cosmetic implant surgery is more lucrative that other procedures because doctors can apply fees freely, without regard to guidelines and limits imposed by insurance companies.

Finally, any doctor - including dentists - is allowed by law to call him- or herself a plastic surgeon and perform breast augmentation surgery. Such doctors do not have the training and experience to properly judge and share with you potential risks. It is critically important that any woman considering implants make sure that the plastic surgeon she selects is board certified by the American Board of Plastic Surgery (ABPS). Certification guarantees that the doctor has graduated from an accredited medical school; has done a proper residency in general surgery, ENT, and plastic and reconstructive surgery; has passed written and oral board exams; and has practiced in the field for at least two years after training.


Q: What Are the Potential Problems Related to the Surgery?

Breast augmentation is surgery, and carries the same risks associated with any surgery. According to the FDA, they would include the possibility of:

  • Hematoma – collection of blood that may cause swelling, pain and bruising and may require additional surgery to drain
  • Hemorrhage – abnormal bleeding
  • Thrombosis – abnormal clotting
  • Skin necrosis – skin tissue death from insufficient blood flow to the skin
  • Numbness and loss of sensation

Q: Will I Be Able to Breastfeed?

Probably yes, but chances are good that you will experience complications.

One study found that up to 64 percent of the implanted women cannot produce enough milk, compared to 7 percent of women without implants. Another study of new mothers with saline implants found that 39 percent have problems breast-feeding. The ability to breastfeed after implant surgery may be related to the skill of the plastic surgeon and the kind of incision.


Q: Do Breast Implants Interfere with Mammography?

When an implant is inserted into a breast, it significantly obscures breast tissue and compromises the ability of mammography to detect tumors. Specially trained technicians are needed to perform mammograms on women with implants, and additional views must be taken (adding to the cost and increasing the woman’s exposure to radiation). Even so, approximately 30 percent of the breast will not be visible. Furthermore, implants can rupture during mammography.


Q: Are There Special Risks for Cancer Patients?

Breast implants are regularly offered as part of cancer treatment. In many cases, they are inserted so seamlessly into the surgery-reconstruction-recovery process that the patient – weakened, dispirited and perhaps fighting for her life – may not realize that receiving implants is a choice.

While the long-term health risks of implants in cancer survivors have not been established due to the absence of research, their short-term effects are well known. Cancer patients who receive breast implants, saline or silicone, are more likely to experience complications than women who get implants for cosmetic reasons.

According to a report from the Institute of Medicine of the National Academy of Sciences, “30 to 40 percent of (reconstruction) patients could expect complications,” including infection, severe contracture, deflation and implant removal. Studies from implant manufacturers Mentor, McGhan and Inamed have shown that approximately three out of four reconstruction patients experience at least one local complication – such as pain, infection, hardening, or the need for additional surgery – in the first three years. In those studies, 46 percent of women with silicone gel implants and 21 percent with saline implants underwent at least one re-operation within three years.

There are reconstructive processes that do not require implants, such as natural tissue transfer. Cancer patients should inquire about alternative reconstructive opportunities and understand that it requires time and a clear mind to research all available options.


Q: Where Can I Get More Information?

Please visit the links in our Helpful Resources section. You should also ask your physician for the manufacturers’ informed consent documents and the FDA consumer brochure.

The FDA Breast Implant Consumer Handbook can be obtained by calling 1-888-INFO-FDA or through the FDA website.