The US Food and Drug Administration (FDA) has issued draft guidance recommending a boxed warning on labelling materials for breast implants.
The FDA’s recommendations come after several complaints from women claiming breast implants have harmed their health.
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The implants are associated with a rare type of cancer of the immune system, breast implant-associated anaplastic large cell lymphoma, according to the FDA.
The guidance, put up for public review in order to be finalised soon, also proposed that patients have to review a ‘decision checklist’ detailing risks with their doctors.
In a statement, FDA principal deputy commissioner Amy Abernethy and FDA’s Center for Devices and Rdiological Health director Jeff Shuren said: “The draft guidance offers numerous recommendations to help ensure women have access to this information, including that manufacturers incorporate a boxed warning and patient decision checklist in the device’s labelling, update recommendations for patient screening for device rupture and more.
“Taken as a whole we believe this draft guidance, when final, will result in better labelling for breast implants that will ultimately help patients better understand breast implant benefits and risks, which is a critical piece in making health care decisions that fit patients’ needs and lifestyle.”
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By GlobalDataIn March, several breast implant patients testified before the FDA during a public advisory panel meeting about breast implant-linked illnesses and cancers. They also raised concerns that adequate information regarding the benefits and risks of the devices are not provided in the labelling for women considering the implants.
In July, Allergan recalled its Biocell breast implants linked to breast implant-linked anaplastic large cell lymphoma.
The FDA has recommended manufacturers to indicate that breast implants are not lifetime devices and come with risks of complications such as developing rare cancer, the longer a patient has the implant.
