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Breast Implant Manufacturers Get Labeling Guidance

Breast Implant Manufacturers Get Labeling Guidance News & Analysis News From the Food and Drug Administration Breast Implant Manufacturers Underastatementofintent,theFDAand Shiga toxin–producing Escherichia coli, Get Labeling Guidance 2 Mexican agencies—the Federal Commis- Vibrio,andYersiniaincreasedcomparedwith New final guidance from the FDA is meant sion for the Protection from Sanitary Risks those reported from 2016 through 2018. to ensure that patients have accurate, timely and the National Service of Agro-Alimentary However, Listeria, Salmonella, and Shigella information on the risks and benefits asso- Health, Safety and Quality—will work on infections remained unchanged from the 3 ciated with breast implants. adapting new technologies to prevent prior years. Stemming from discussions with its Gen- and trace foodborne illness outbreaks as Inall,theFoodborneDiseasesActiveSur- eral and Plastic Surgery Devices Advisory wellascollaboratewithotherentitiesinclud- veillance Network identified 25 866 infec- Panel in 2019, the FDA has recommended ing academia, consumer groups, and the pri- tions, 6164 hospitalizations, and 122 deaths thatmanufacturers’labelingincludeapromi- vate sector. from foodborne pathogens in 2019, accord- nent boxed warning and a standardized pa- ing to the CDC report. tient decision checklist that covers contra- indications, surgical risks, the risk of Warning Concerns Respirator developing breast implant–associated ana- Decontamination System plastic large cell lymphoma (BIA-ALCL), and The FDA has warned the Battelle Memorial Institute, a http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png JAMA American Medical Association

Breast Implant Manufacturers Get Labeling Guidance

Jaklevic, Mary Chris
JAMA , Volume 324 (19) – Nov 17, 2020
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Breast Implant Manufacturers Get Labeling Guidance

Abstract

News & Analysis News From the Food and Drug Administration Breast Implant Manufacturers Underastatementofintent,theFDAand Shiga toxin–producing Escherichia coli, Get Labeling Guidance 2 Mexican agencies—the Federal Commis- Vibrio,andYersiniaincreasedcomparedwith New final guidance from the FDA is meant sion for the Protection from Sanitary Risks those reported from 2016 through 2018. to ensure that patients have accurate, timely and the National Service of Agro-Alimentary...
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Publisher
American Medical Association
Copyright
Copyright 2020 American Medical Association. All Rights Reserved.
ISSN
0098-7484
eISSN
1538-3598
DOI
10.1001/jama.2020.22066
Publisher site
See Article on Publisher Site

Abstract

News & Analysis News From the Food and Drug Administration Breast Implant Manufacturers Underastatementofintent,theFDAand Shiga toxin–producing Escherichia coli, Get Labeling Guidance 2 Mexican agencies—the Federal Commis- Vibrio,andYersiniaincreasedcomparedwith New final guidance from the FDA is meant sion for the Protection from Sanitary Risks those reported from 2016 through 2018. to ensure that patients have accurate, timely and the National Service of Agro-Alimentary However, Listeria, Salmonella, and Shigella information on the risks and benefits asso- Health, Safety and Quality—will work on infections remained unchanged from the 3 ciated with breast implants. adapting new technologies to prevent prior years. Stemming from discussions with its Gen- and trace foodborne illness outbreaks as Inall,theFoodborneDiseasesActiveSur- eral and Plastic Surgery Devices Advisory wellascollaboratewithotherentitiesinclud- veillance Network identified 25 866 infec- Panel in 2019, the FDA has recommended ing academia, consumer groups, and the pri- tions, 6164 hospitalizations, and 122 deaths thatmanufacturers’labelingincludeapromi- vate sector. from foodborne pathogens in 2019, accord- nent boxed warning and a standardized pa- ing to the CDC report. tient decision checklist that covers contra- indications, surgical risks, the risk of Warning Concerns Respirator developing breast implant–associated ana- Decontamination System plastic large cell lymphoma (BIA-ALCL), and The FDA has warned the Battelle Memorial Institute, a

Journal

JAMA – American Medical Association

Published: Nov 17, 2020

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