FDA plans meeting to discuss safety data on breast implants
US health regulators say they’ll convene a public meeting of medical advisers next year to discuss new science on breast implant safety, including an independent analysis that suggests certain rare health problems might be more common with silicone gel implants.
The Food and Drug Administration said it would hold the meeting even as its officials and several independent experts disputed the new work. Leaders of the study concede that it has big limitations and cannot prove that implants cause any of these problems.
Yet it involves nearly 100,000 women and is the largest long-term safety analysis of silicone implants since 2006, when they were allowed back on the US market after a 14-year gap due to safety concerns.
‘‘We completely stand behind this study and we do feel it’s our best data to date,’’ said lead researcher Dr. Mark Clemens, a plastic surgeon at the University of Texas MD Anderson Cancer Center. Women need as much information as possible to make an informed decision about whether and what kind of implant to get, he said.
The journal Annals of Surgery plans to publish the report on Monday. Study leaders have no current ties to implant makers, although Clemens consulted for one in the past.
Each year in the United States, about 400,000 women get an implant and most choose silicone over saline; surgeons say it can give a more natural look. Three-fourths are for women who want bigger breasts; the rest are for reconstruction after cancer surgery.