FDA Updates Breast Implant Regulations, Adds Boxed Warning

The agency is working to close information gaps for anyone considering breast augmentation.

Nov 2, 2021

In 2019, women testified that their doctors didn’t properly warn them of the potential health risks of breast implants. This pushed the FDA to restrict the sale of breast implants to only providers who provide patients a standardized checklist outlining the potential complications. Now, two years later, a CNN article reported that the FDA has changed regulations on breast implants, and is requiring new labeling with a boxed warning.

Medical Device Innovations Report

Pharmaceutical Innovations Report

List: Digitalization Companies From PACK EXPO

Currently more than half of US drugs are manufactured overseas and only 11% of APIs are produced in the U.S.

FDA Launches PreCheck to Accelerate Domestic Drug Facility Approvals

The two-phase program is designed to expedite the approval of new pharmaceutical manufacturing facilities in the U.S. by providing enhanced regulatory guidance and communication to manufacturers.

Pharmaceutical Packaging Innovations Report Video Interview

Through the Line: Packaging and Processing

Through the Line Podcast: Improving DSCSA Data Exchange Accuracy

2025 Packaging State of the Industry: U.S. Expands, Canada Maintains

Ullrich Mayeski, director of customer success- healthcare GS1 US shares why supply chain visibility is more critical now than ever before.

Why Is Supply Chain Visibility and Transparency More Critical Now Than Ever Before?

Break out of the ordinary: see what’s new in life sciences packaging

At PACK EXPO Las Vegas, you’ll see machinery in action and new tech from 2,300 suppliers, collaborate with experts and explore transformative solutions. Join us this month to experience a breakthrough for life sciences products.

Medical Device Innovations Report

Cutting-edge packaging technologies are transforming the medical device sector in PMMI’s “Innovation in Medical Device” report, featuring advanced materials, smart solutions, and evolving regulations. Editors share insights from nearly 300 PACK EXPO booth visits—each product deemed new and truly innovative—alongside video demonstrations of the equipment and materials on display.

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