Potential Risks and Complications

Information for Women considering Saline-Filled Breast Implants

Saline-filled breast implants (silicone envelopes containing salt water) were already in use in 1976 when the Food and Drug Administration (FDA) began regulating medical devices. The 1976 law allowed manufacturers to continue selling devices already on the market ("grandfathered" the devices), but also stated that, at some time in the future, manufacturers would need to provide the FDA with additional evidence on the safety of breast implants. Research on breast implants continues on an ongoing basis and the data will be provided to the FDA when requested. In May 2000, the saline implant companies received their pre-market approval (PMA), a rigorous evaluation the the implants, deeming saline implants safe and effective for their general use.

Dr. Adams is a nationally recognized and published author regarding breast implants and breast augmentation. He will be happy to answer any question you may have during the consultation.

Most Common Risks

1. Deflation: Breast implants do not last forever. A small percentage of implants can deflate (or rupture) in the first few months or years after being implanted; yet some are intact 10 or more years after the surgery. Predicting how long an implant will last, is not yet possible. However, researchers (including Dr. Adams) are studying deflation rates over time. Current data has indicated that current saline implants may last longer than silicone implants. Whether the implant breaks through normal wear or due to breast injury, it releases its saline (salt water) into the body. This usually happens quickly and surgery is then required to remove and, if desired, replace the deflated implant. Since salt water is naturally present in the body, the leaked saline will be safely absorbed by the body instead of being treated as foreign matter. Dr. Adams will quote a 1% per year deflation rate to his patients.

2. Making breast cancer harder to find: Breast implants may interfere with finding breast cancer during mammography by "hiding" suspicious-looking patches of tissue and making the mammogram more difficult to interpret. The implant may also make the x-ray harder to perform. Since the breast must be squeezed during mammography, every woman who has a breast implant must tell the technologist before the procedure. The technologist can use special techniques to minimize the possibility of deflation and obtain the best possible views of the tissue. However, more x-ray reviews are necessary when these special techniques are used, so women with breast implants will typically receive more radiation than women without implants. Still, the usefulness of a mammogram in finding cancer far outweighs the risk of the additional x-rays. There are also evolving techniques for breast screening (MRI) that is not affected by the presence of an implant.

3. Capsular contracture: In capsular contracture, the scar tissue (or capsule) that normally forms around an implant gradually tightens and squeezes the implant. Over several months or years, a breast may change shape, harden or become painful. Severe capsular contraction is not common, but it may require surgical removal of the implants. Capsular contracture is currently Dr. Adams' primary research focus. He has developed several techniques to help prevent contracture, and contunues to develop other techniques that will hopefully mimimize this risk. The incidence of capsular contracture in saline breast augmentation is low, and Dr. Adams utilizes several special intra-operative and post-operative measure to help prevent this from occurring.

4. Loss of nipple sensation: Feeling in the nipple and breast can increase or decrease after implant surgery. Changes in feeling can be temporary or permanent and may affect sexual response or the ability to nurse a baby.

Most data suggests that loss of nipple sensation occurs in approximately 7% of the procedures. In some of these cases this may be only temporary but, permanent loss of nipple sensation is possible.

Continue reading about the potential risks and complications of breast augmentation.

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