US FDA Panel Calls for Silicone Breast Implant Registry

The two companies that manufacture silicone implants -- Allergan and Mentor -- are required to follow women who've had their implants for a number of FDA-mandated studies, but enrollment in those follow-up studies has been disappointing, and in some cases the number of women being followed is so small that FDA cannot definitely rule out a connection between implants and a rare disease, such as anaplastic large-cell lymphoma or connective tissue diseases.

The FDA's General and Plastic Surgery Devices Panel, which wrapped up a two-day meeting Wednesday afternoon, said that current data collection demands are too onerous. Both companies ask women who've received their implants to fill out a 25-plus page questionnaire every year following surgery. Not surprisingly, not many women do that.

In 2006, the FDA broke a 14-year moratorium on silicone implants by approving two new models, one made by Mentor and one by Allergan. The approval was controversial because critics of silicone implants said there wasn't enough evidence that the implants were safe in the long term.

To study how the implants held up longer-term, the FDA ordered Mentor and Allergan to perform an array of follow-up studies -- some of which won't end until 2016. The studies involve 80,000 implant recipients -- 40,000 for each of the two brands -- who will be followed for a decade.

But so far, Allergan has mustered only about a 60% follow-up rate after two years for its studies -- far short of the goal of 93% -- and only one in four patients who received a Mentor implant were followed up after two years.