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Calls at hearing for label on breast implants’ risks
[SILVER SPRING, Maryland] Women with illnesses linked to breast implants challenged plastic surgeons, regulators and implant makers at a meeting Monday at the Food and Drug Administration, demanding more information about the risks of the implants and calling for a ban on one that is associated with an unusual type of cancer.
They asked implant makers to disclose the materials used in the devices and also called for a "black box" warning — a label the FDA can require, noting heightened problems with a drug or device.
The implants that some patients and advocates want removed from the market have a textured or slightly roughened surface and have been associated with anaplastic large cell lymphoma, a cancer of the immune system. Dozens of other countries have already banned one type of textured implants, made by Allergan.
Industry representatives defended implants, as did plastic surgeons, including several female surgeons who said they had implants themselves and had many patients who had no health problems.
The FDA's general and plastic surgery devices panel is holding the two-day public forum to hear from researchers, advocates, patients and the industry about the implants.
While the panel took no formal votes, its members were to consider further steps for the agency to take in exploring the growing scientific evidence about both breast implant-associated lymphoma and a constellation of debilitating symptoms generally referred to as breast implant illness.
The panel's experts repeatedly expressed frustration at the dearth of good data on implants and the failure of breast-implant makers to complete promised studies or follow patients for long enough to collect meaningful data.
"We have a surprisingly limited amount of clear and consistent data given the number of years and the number of women involved," said Natalie Compagni Portis, a patient representative on the panel.
The expert panelists debated whether to restrict the use of textured implants, which have been more closely linked to the risk of lymphoma than smooth implants, but which also offer certain surgical advantages.
But only a minority of the panelists seemed to favor banning them. The panel expressed interest in identifying what specific personal and family medical histories may make women more vulnerable to becoming ill after receiving implants.