Draft Guidance: FDA to Place a Boxed Warning on Breast Implants
The FDA released a Statement (October 2019) with proposed draft guidance that will include a ‘boxed warning’ on labeling for breast implants as well as an additional checklist and updated recommendations
Boxed Warning to include notification of risks including
Breast implants are not lifetime devices
Complication risks increase with the length of time the patient has had the implant and presence of additional surgeries
Risk for breast implant-associated anaplastic large cell lymphoma (BIA-ALCL)
Risk for systemic symptoms such as fatigue or joint pain
Patient Decision Checklist that will provide patients an opportunity to
“Acknowledge individual risks of breast implants” that include risk of BIA-ALCL and implant rupture, among others
Importance of surgeon’s experience, education, training and credentials
Risk of implant surgery
Rupture screening recommendations will be revised for patients with silicone gel-filled breast implants
Currently, approved labeling recommends MRI screening for patients beginning 3 years following implantation and every other year thereafter
New draft recommendations propose either ultrasound or MRI at 5 to 6 years following implantation and then every 2 years thereafter
If patient symptomatic or uncertain ultrasound result, MRI is recommended
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