How do I know a breast implant is safe?

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.

‘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. Breast pain, breast hardness and numbness in the nipple are common complications that may last for years, and may never go away.

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.

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.

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 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.