The US Food and Drug Administration will continue to evaluate the safety of silicone breast implants before making a decision on reapproval, despite a recent recommendation from its advisers.
After a marathon two day hearing last week, the FDA's advisory panel on plastic surgery voted to end the 10 year moratorium on silicone implants for breast enlargement, though safety concerns saw the panel spilt, with a vote of nine to six in favour.
The advisory panel had considered results of the first three years of a planned 10 year open label study involving 940 women of all age groups, using an implant made by the California based company Inamed.
For those who had breast implants for enlargement (rather than reconstruction) the study found that at three years a fifth had already undergone repeat surgery, 6% had breast pain, 3% had experienced a change in nipple sensation, and 1% had experienced a rupture.
Dr Sidney Wolfe, director of the Public Citizen's Health Research Group, argued before the panel that the study's results underestimated safety concerns. He presented evidence showing that complication rates continue to rise the longer they are inside the body.
Using five year data from previous studies, he showed that 27% of women had repeat surgery, 27% of women had breast pain, 17% lost nipple sensation, and 4% had rupture of an implant (a rate that rises rapidly the older implants become).
Other data from the FDA, not specific to the applicant's products, show that after12 years, up to 26% of silicone implants may rupture, and in many cases the rupture may be unnoticed. Public Citizen and several advocacy organisations are urging the FDA not to approve the reintroduction of silicone implants for use in breast enlargement, but to retain their restricted status for reconstruction.
Cynthia Pearson, executive director of the National Women's Health Network, told the BMJ that she was particularly concerned by data from the most recent study showing that for a range of symptoms—including joint and muscle pain, stiffness, and fatigue—women were doing worse just two years after having implants.
Figure 1.
Campaigners against the approval of silicone gel implants rally outside the Department of Health in Washington earlier this month
Credit: RON EDMONDS/AP