Brown, S. Lori, et al. “Prevalence of rupture of silicone gel breast implants revealed on MR imaging in a population of women in Birmingham, Alabama.” American Journal of Roentgenology: 2000.
In 2000, researchers at the FDA published a study showing that silicone breast implant rupture was much more common than previously thought. The study included 907 women in the Birmingham, Alabama area who had silicone gel-filled breast implants for at least six years. The study had two components.
In the first part, FDA researchers interviewed the 907 women to ask how many had removed their implants due to rupture or suspected rupture. Women who had surgery because they suspected their implants were ruptured were asked about what symptoms they had and whether they knew of a possible reason that their implants could have ruptured. Researchers found that one-third of the women interviewed (303 of 907) reported that they had at least one operation to remove or replace a breast implant. The most common reason for additional surgery was due to complications such as pain, capsular contracture, rupture, or suspected rupture. Women also cited concern about the safety of silicone as a reason for removal.
In the second part of the study, the FDA researchers recruited 344 women from the Interview Study to have a breast coil MRI exam to determine if their implants were ruptured. Three radiologists looked at each of the MRIs and determined if the implants were intact, suspicious for rupture, or ruptured. Researchers found that 77% of the women had at least one breast implant that was ruptured or suspicious for rupture. Researchers also noted that 21% of the women with at least one ruptured implant had silicone gel that had leaked outside the scar tissue capsule that formed around the breast.
There were several factors that affected the likelihood that an implant had ruptured, such as the age of the implant, which manufacturer made the implant, and whether the implant was put above or beneath the chest muscle. Almost half of the women who had implants for only six to 10 years had at least one ruptured implant. Even more, 79%, of the women who had implants for 11-15 years had at least one ruptured implant. Researchers also found that women whose implant was above the chest muscles were less likely to have a ruptured implant than women whose implant was below the chest muscle.
In summary, the study found that breast implant rupture and leakage was much more common than previously thought. Most rupture was “silent” in that there were no symptoms that warned the women that they had a rupture. Silicone from a ruptured implant can migrate into the breast and arms and into the lymph nodes under the arm; from there it can go to the lungs, liver, or other organs.
The most accurate way to check for rupture is to get a breast coil MRI. The FDA recommends getting an MRI starting three years after receiving your implants and every two years after that.
Read the original study here
Read the FDA analysis of the interview portion here