FDA Calls for New Warning on Breast Implants
The US Food and Drug Administration (FDA) on Wednesday issued draft guidance calling for a new boxed warning among other measures to ensure patients receiving saline or silicone gel filled breast implants are more aware of their risks.The draft guidance includes recommendations made during a two-day meeting of the General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee last March that covered a range of safety and surveillance issues related to breast implants including breast implant associated-anaplastic large cell lymphoma (BIA-ALCL), systemic symptoms reported by patients and the use of registries and real-world data to gather data about the devices.
The guidance also comes just months after Allergan pulled its Biocell textured breast implants from the market in response to a request from FDA to recall the devices due to concerns about BIA-ALCL after an analysis found that 84% of medical device reports citing the condition were related to Allergan implants.
Draft Guidance
In the guidance, FDA lays out its recommendations for breast implant labeling, including the addition of a boxed warning and patient decision checklist.
FDA notes that the guidance should be read in conjunction with its 2001 Guidance on Medical Device Patient Labeling and its 2006 guidance Saline, Silicone Gel, and Alternative Breast Implants and is not effective at this time.
The boxed warning includes three bullets informing patients that breast implants are “not considered lifetime devices” and that complications grow more likely over time; the association of breast implants with BIA-ALCL; and that patients with breast implants have reported having systemic symptoms after receiving breast implants including joint pain and chronic fatigue.
“Calling out this information in a boxed warning will help ensure patients see this important information,” FDA Principal Deputy Commissioner Amy Abernethy and Center for Devices and Radiological Health Director Jeff Shuren said in a joint statement.
FDA recommends that manufacturers include a patient decision checklist to be reviewed before receiving breast implants that reviews key safety information about the devices. An example of a patient decision checklist is included in the appendix.
The guidance also provides additional recommendations for rupture screening, describing materials used in the devices and patient device cards that will supersede or supplement those made in the 2006 guidance when finalized.
For rupture screenings, FDA has revised its recommendations to delay the first screening for asymptomatic patients, recommending that patients without symptoms be screened five or six years after receiving implants and every two years from then on.
FDA, Draft Guidance, Federal Register Notice