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FDA Warns of Mesh Use in Breast Surgery after BD Updates Labels

Currently, there are no surgical mesh products cleared or approved by FDA for use in breast surgery.

Katie Hobbins

November 14, 2023

1 Min Read
Surgical Mesh
PhotoGraphyKM / iStock via Getty Images

FDA last week released a statement informing healthcare providers about labeling updates for Becton, Dickinson and company (BD) mesh products, reminding individuals that the use of surgical mesh products in breast surgery has not been determined by the administration to be safe and effective.

The labels were updated on the following products:

  • Phasix Mesh

  • Phasix ST Mesh

  • Phasix Plug and Patch

  • Phasix ST Mesh with Open Positioning System (OPS)

  • Phasix ST Mesh with Echo 2 Positioning System, and

  • GalaFLEX Lite Scaffold

  • GalaFLEX Scaffold

  • GalaFLEX 3D Scaffold

  • GalaFLEX 3DR Scaffold

The products, which are cleared for the repair and reinforcement of soft tissue where weakness exists, saw updates to their warnings and precautions.

FDA said that it is aware of increased use of surgical mesh products in breast surgery but that “the safety and effectiveness of surgical mesh in breast surgery, including in augmentation or reconstruction, has not been determined,” according to the statement. Currently, there are no surgical mesh products cleared or approved by FDA for use in breast surgery.

The administrations stance affirms previously communicated recommendations from the General and Plastic Surgery Devices Panel held March 25-26, 2019. Of note, FDA is not recommending reoperation or removal of implanted surgical mesh in asymptomatic patients.

About the Author(s)

Katie Hobbins

Managing Editor, MD+DI

Katie Hobbins is managing editor for MD+DI and joined the team in July 2022. She boasts multiple previous editorial roles in print and multimedia medical journalism, including dermatology, medical aesthetics, and pediatric medicine. She graduated from Cleveland State University in 2018 with a bachelor's degree in journalism and promotional communications. She enjoys yoga, hand embroidery, and anything DIY. You can reach her at [email protected].

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