The FDA approved the silicone gel breast implant for use in primary breast augmentation in November of 2006. This lifted a moratorium on the silicone gel implants since 1992. The FDA's decision to approve these implants was based on clinical studies, which demonstrated that these products were safe and effective. In the past decade, multiple independent studies concluded there is no strong evidence that silicone gel breast implants are associated with any disease including autoimmune disease and fibromyalgia. In addition, review of other independent scientific studies supported the safety and efficacy of silicone gel implants for breast augmentation. The FDA will continue to monitor the safety of the silicone gel implants with large post-approval study. Silicone gel breast implants manufactured today are more durable and may potentially last for several decades. All implants, however, will eventually rupture over time and most will require surgical intervention.

Physical examination alone after breast augmentation is inadequate to evaluate suspected implant rupture. Most silicone gel implant ruptures are found incidentally on radiological exams. Unlike saline, where some deflation will occur, a silent ruptured silicone gel implant may not look or feel any different. If this occurs, patients are strongly advised to see your plastic surgeon for implant removal. You may electively have the implants removed and replaced with either silicone gel or saline breast implants. Your other option would be removal without replacement. Silent silicone gel implant rupture is not considered to be an emergency so implant removal should be done in a reasonable amount of time.

Others may complain of vague pain, a lump in their breasts, change in breast size or shape, or increasing firmness. Any change in your breast shape, feel, or pain warrants a thorough examination. Most with these symptoms will ultimately require surgical intervention. Most palpable lumps are likely to be silicone bleed but only a biopsy can rule out a tumor. Procedures may involve removal of the implant, removal of the capsule, re-positioning of the breast tissue, and re-insertion of the implant. Other procedure such as a breast lift may also be warranted.

Silicone gel breast implants used for breast augmentation can potentially remain intact for many decades but all will fail eventually. Some will remain silent and undetected for years. The current implants represents manufacturing improvements over the last several decades. The newer implant shells decreases gel leakage or bleed and are also filled with a thicker more cohesive gel. These improvements have increased the durability of the silicone gel implants. Routine removal and replacement of silicone gel implants at predetermined interval are not necessary and often impractical. If you suspect an implant rupture or have noticed changes to your breast, seek your plastic surgeon for further information.