Are they safe?
The FDA has approved silicone gel breast implants 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.
Saline breast implants are approved by the FDA for women over 18. Why the difference? All breast implants will eventually break and leak into the body. The FDA believes that there are more serious safety questions as well as cosmetic problems when silicone gel implants leak into the body, than when saline implants leak. That’s because saline is salt water, which is not dangerous.
The FDA has approved saline breast implants made by two manufacturers, Inamed (also called McGhan or Allegan) and Mentor. The FDA has approved silicone gel breast implants made by those same two companies, and also by Silimed. All breast implants can cause problems, but breast implants made by other companies haven’t been tested for safety and are not allowed to be sold in the U.S. If you get implants made by other companies in other countries, they may be more likely to break or cause problems.
The FDA decided that breast implants are “reasonably safe” for most women, but that women need to be accurately informed about the risks.
“Reasonably safe” does not mean safe for everyone. The FDA found that most implant patients have at least one serious complication within 3 years after getting their silicone or saline implants.
The purpose of the 10-year studies is to find out how many health problems are likely during the first 10 years that a woman has implants. Unfortunately, there have been so many problems with the studies that they are not likely to be able to answer those questions.
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 common, called capsular contracture, is when the scar tissue inside your body tightens around the breast implant. That can cause the implant to feel very hard and painful, and can make the shape look unnatural, as if you have 2 balls on your chest.
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, and some will need 2 or more surgeries.
Complications are even more common among women getting breast implants after a mastectomy. Four out of every 10 reconstruction patients need additional surgery within three years of getting implants.
If you are thinking of having children in the future, it is important to know that breast implants may interfere with your ability to breastfeed. Breast milk is the best food for babies, so you may want to delay getting breast implants until after you are done having children.
How long do breast implants last?
It is impossible to predict 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 more expensive those problems are going to be.
Eventually, you will need to get your implants replaced. A study by FDA scientists found that by the time a woman has implants for 10 years or more, at least one of them has broken.
Why 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. 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 implant, 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.
The pressure from mammography can 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 or she is qualified to perform your mammogram.
Closed capsulotomy can also cause an implant to rupture, and should never be done. Closed capsulotomy is the name for a procedure when a woman has capsular contracture and the doctor squeezes the breast very hard to try to break the scar tissue capsule. Unfortunately, the squeezing can break the implant as well as the capsule.
How much do breast implants cost after the initial surgery?
Most women pay $4,000-7,000 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.
Experts at the FDA warn 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.
Women with saline breast implants do not need MRIs to detect rupture because saline implants deflate when they are ruptured. That makes it obvious that the implant has broken, but it is not dangerous unless there are bacteria in the implant.
Your health insurance will not pay for breast augmentation or other kinds of cosmetic surgery. Most insurance companies will not pay for most complications or medical problems that result from breast augmentation, and they will not pay for MRIs to check for rupture. 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.
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. However, the scientists who did the study aren’t sure whether that is conclusive or just happened by chance.
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 what kinds of problems can happen to women who have breast implants.
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.
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.