What You Need to Know Before You Get Breast Implants

Are they safe?
In November 2006, the FDA approved silicone gel breast implants for the first time, but only for women who are 22 or older. And because of serious concerns about safety, the FDA is requiring implant makers to study 80,000 women with breast implants for 10 years.

Previous studies have only evaluated women with breast implants for three years, The newly required studies will be used to find out whether or not silicone gel implants are safe.

The FDA has approved silicone gel breast implants and saline breast implants made by two manufacturers, Inamed (also called McGhan or Allegan) and Mentor. The FDA decided that breast implants are “reasonably safe” for most women for the three years that were studied, but unfortunately saline implants were not studied for long-term safety.

Silicone or saline breast implants by companies other than Inamed and Mentor are not considered to be “reasonably safe” by the FDA.

“Reasonably safe” does not mean safe for everyone. The FDA found that most implant patients have at least one serious complication within three years after getting their silicone or saline implants.

What complications should I expect?
Breast pain, breast hardness, and numbness in the nipple are common complications that may last for years, and may never go away.

The most serious complications include toxic shock syndrome, implants breaking through the skin, or skin dying. A few studies have shown that patients have died or had gangrene as a result of breast augmentation surgery. These are rare but they do happen.

Many breast augmentation patients need additional surgery within 5 years of getting breast implants. Within 10-12 years, most women will need at least one additional surgery.

4 out of 10 reconstruction patients need additional surgery within three years of getting implants.

Breast augmentation may interfere with your ability to breastfeed.

There are serious concerns about whether a leaking implant could harm a nursing infant, but no studies have been conducted.

How long breast implants last
It is unpredictable how long an implant will last. Some implants break within a few days, weeks, or months, while others last for many years.

Like most new products, most implants seem fine for the first few years. Think of implants as being as reliable as a car – problems can happen anytime, but the older they get, the more problems you are likely to have.

The FDA found that by the time a woman has implants for 10 years, at least one of them has broken. However, it is not always obvious.

How do implants break?
All breast implants have the same basic design. Implants are made up of a silicone envelope, with a filling of some kind--usually either saline or silicone gel. Because of this design, all breast implants can develop a tear or hole and leak their contents. Whether the hole or tear is large or small, it's called a rupture.

Ruptures can happen simply as implants age, or because of a blow to the chest, such as in a car accident, or a bad fall. Tears or holes can be caused by a defective envelope, by a nick from a needle during a biopsy, or even when the surgeon is closing the incision in your chest after putting the implants inside you.

Saline implants have a valve. If you have saline implants, the surgeon will place the empty silicone envelope in your chest, and then use the valve to fill the envelope with saline. If the valve is defective, or breaks, it will leak.

Mammograms can potentially cause an implant to break, especially if the implants are old or the mammography technician is not trained to work with breast implants. You should always tell the technician that you have breast implants, and make sure that he/she is qualified to perform your mammogram.

Closed capsulotomy can also cause an implant to rupture. This procedure is performed when you have capsular contracture. It involves a doctor squeezing the breast very hard between his or her hands in an attempt to break the scar tissue capsule. Often, the implant as well as the capsule is broken. This procedure is considered dangerous and is no longer recommended.

How much breast implants cost after the initial surgery
Most women pay $4,000-6,000 for their first augmentation surgery with saline implants, and approximately $1,000 more with silicone gel implants. If a doctor is charging less than that, be very cautious. Make sure he or she is a board-certified plastic surgeon and is very experienced with implants.

When they approved silicone gel breast implants, the FDA stated that women with silicone gel breast implants should have a breast MRI three years after getting silicone implants and every two years after that. The purpose of the MRIs is to determine if the silicone gel breast implants are ruptured or leaking, because there are often no symptoms. It is important to remove silicone implants if they are ruptured, to avoid the silicone leaking into the breast or lymph nodes. Breast MRIs usually cost at least $2,000, sometimes more.

Your health insurance will not pay for breast augmentation. Most insurance companies will not pay for complications or even serious medical problems that result from breast augmentation, and they will not pay for MRIs to check for rupture. Women with saline breast implants do not need MRIs to detect rupture because saline implants deflate when they are ruptured.

Before your surgery, check to find out if your health insurance company might drop you from coverage because of implants, or refuse to renew your coverage, or stop covering breast conditions or certain illnesses that are believed to be related to implants.

Every week we hear from women who want to have their implants removed and cannot afford to do so.

If you have to pay for breast implants on an installment plan or by borrowing money, then it is very risky to get breast implants. You might still be paying off your surgery when serious implant problems arise. It often costs more to get implants removed than to have them put in.

Having breast augmentation surgery in other countries or from doctors who are not board-certified plastic surgeons might cost less, but if there are problems it will cost you much more to find a surgeon to fix them.

If your doctor says he or she will replace your implants for free, be sure to ask if that includes the cost of the hospital room, anesthesiologist, and other expenses, and if not, how much those would cost.

If the company that made your implants offers insurance, check to see what it covers. Does it cover all kinds of problems? Does it cover the cost of the implants and the surgery and anesthesia?

Do breast implants cause cancer?
Breast implants do not cause breast cancer, but they make it more difficult to detect breast cancer because they can hide tumors.

Mammograms can’t see through breast implants, and the most recent research indicates they will miss the tumors of half of the augmented women who have breast cancer.

Mammograms must be performed by a skilled technician who is aware that you have implants. This costs more, takes longer, and will expose you to more radiation each time you have a mammogram. And according to a study by FDA scientists, mammograms can cause implants to rupture.

Research by the National Cancer Institute has found that women with breast augmentation are more likely to die of brain cancer or lung cancer compared to other plastic surgery patients.

What to ask your doctor
If you decide to get breast implants put in or taken out, make sure you only use a board-certified plastic surgeon.

If your doctor shows photographs of patients, ask if they were his or her own patients. Ask to see photographs of how they looked a few years later.

If your doctor tells you that breast implants are proven safe, ask for a copy of any report that studied women with implants for at least 10 years.

Ask your doctor for written information about the risks of breast implants and read that information at least one week before surgery, so you have time to ask questions or gather more information.

Any woman who considers silicone gel implants should ask for the informed consent form at least one week before surgery.

If your doctor says all of his or her patients are happy with their results, ask to speak to patients who have had implants for at least 7-10 years.

Legal Issues
Many women wonder why implant companies agreed to a legal settlement for billions of dollars to help women harmed by breast implants, and yet breast implants can still be sold today. To read a report summarizing these legal issues, written by the Alliance for Justice, click here

What do the experts say about breast implants?
Well-respected women's health expert Dr. Susan Wood and the former president of the American Society of Plastic Surgeons, Dr. Scott Spear, spell out the risks of silicone breast implants in a new article. To read a summary, click here.

For more information about health risks, go to the Augmentation, Reconstruction, or Scientific Research sections of this website.