US FDA proposes boxed warning for breast implants

US FDA proposes boxed  warning for breast implants

The US FDA has issued proposed labelling recommendations to manufacturers of breast implants to help ensure women receive and understand information regarding the benefits and risks of these devices.

The agency has proposed a boxed warning to be included in labelling for breast implants. The warning will identify certain risks including that breast implants are not lifetime devices. 

The chances of developing complications increase the longer a patient has the implant and additional surgery may be required to address the complications. 

The breast implants have been associated with the risk of developing anaplastic large cell lymphoma (BIA-ALCL) and may be associated with systemic symptoms like fatigue or joint pain. 

Additionally, the draft guidance recommends that manufacturers include a patient decision checklist at the end of a patient informational booklet or brochure. 

The checklist can be used to help guide discussion during a patient’s consultation with a surgeon. A checklist gives patients the opportunity to acknowledge individual risks of breast implants, such as potential risks from the surgery, the risk of BIA-ALCL and risk of implant rupture, among others.

Another recommendation focuses on revising the rupture screening recommendations for patients with silicone gel-filled breast implants. Previously, the FDA recommended that labelling include the methods and frequency of screening for rupture, and currently approved labelling recommends magnetic resonance imaging (MRI) screenings for patients beginning three years following implantation and every other year thereafter. 

The new recommendations propose that patients without symptoms be screened using either ultrasound or MRI at five to six years following implantation and then every two years thereafter. If a patient has symptoms at any time or uncertain ultrasound results for breast implant rupture, an MRI is recommended.

These recommendations are based on data showing rupture rates are higher five to six years after implantation, recommendations from the American College of Radiology, recommendations from the FDA panel meeting earlier this year.

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