Tag: medical devices

FDA requests Allergan to recall certain breast implants and tissue expanders from market

Allergan Voluntarily Recalls BIOCELL® Textured Breast Implants and Tissue Expanders, 07.24.2019

“The U.S. Food and Drug Administration today took significant action to protect women from breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) by requesting that Allergan, the manufacturer of a specific type of textured implant, recall specific models of its textured breast implants from the U.S. market due to the risk of BIA-ALCL. Following the agency’s request, Allergan has notified the FDA that it is moving forward with a worldwide recall of their BIOCELL textured breast implant products, including: Natrelle Saline-Filled breast implants, Natrelle Silicone-Filled breast implants, Natrelle Inspira Silicone-Filled breast implants, and Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Filled breast implants. The recall also includes tissue expanders used by patients prior to breast augmentation or reconstruction, including Natrelle 133 Plus Tissue Expander and Natrelle 133 Tissue Expander with Suture Tabs. The recall helps ensure that unused products are removed from suppliers and doctors’ offices. The agency also issued a safety communication today for patients with breast implants, patients considering breast implants and their health care professionals outlining the known risks and what steps patients should consider when monitoring for symptoms of BIA-ALCL, including swelling and pain in their breasts. The safety communication also lists information about all models and style numbers included in the recall.” …

… continue reading The FDA Takes Action to Protect Patients from Risk of Certain Textured Breast Implants; Requests Allergan Voluntarily Recall Certain Breast Implants and Tissue Expanders from the Market: FDA Safety Communication, 25/07/2019.

Hidden FDA Reports Detail Harm Caused By Scores Of Medical Devices

The Food and Drug Administration has let medical device companies file reports of injuries and malfunctions outside a widely scrutinized public database, which leave doctors and medical sleuths in the dark

Kaiser Health News senior correspondent Christina Jewett explains how she investigated a Food and Drug Administration database where medical device makers report malfunctions and patient injuries, skirting the public record. Because the cache of information is buried deep within the agency, it’s often hard for physicians, researchers and patient safety advocates to access the information.

What inspired ICIJ investigation into the medical device industry ?

Implant Files, video published by ICIJ, 8 March 2019

ICIJ year-long investigation into the medical device industry started with one reporter — Jet Schouten — and her very original use of a mandarin orange net.

ICIJ “fights corruption with the world’s best cross-border watchdog journalism by over 160 investigative reporters in 60+ countries. The home of Offshore Leaks.”

How to use the International Medical Device Database

Implant Files, video published by ICIJ, 27 February 2019

ICIJ show you how to navigate their public medical device database, now containing 90,000+ records from 18 countries. There you can find safety alerts and recalls for thousands of medical devices.

ICIJ “fights corruption with the world’s best cross-border watchdog journalism by over 160 investigative reporters in 60+ countries. The home of Offshore Leaks.”

Laura’s breast implant story

Implant Files, video published by ICIJ, 26 November 2018

“Thank you for watching! So thankful to have support. It is a journey I never thought I would have to take, but I hope that my voice is making a difference”.

Laura McCandliss, January 2019.

Read more about ICIJ implant files investigation.

ICIJ “fights corruption with the world’s best cross-border watchdog journalism by over 160 investigative reporters in 60+ countries. The home of Offshore Leaks.”

Meet the people who lived with defective devices

Implant Files, video published by ICIJ, 25 November 2018

ICIJ listened to hundreds of stories from patients with poorly-functioning medical devices. Here are just five of their testimonies.

Read more about ICIJ implant files investigation.

ICIJ “fights corruption with the world’s best cross-border watchdog journalism by over 160 investigative reporters in 60+ countries. The home of Offshore Leaks.”

Why join the Implant Files investigation ?

Implant Files, video published by ICIJ, 25 November 2018

Journalists explain why they decided to investigate medical device harm with ICIJ reporters.

Read more about ICIJ implant files investigation.

ICIJ “fights corruption with the world’s best cross-border watchdog journalism by over 160 investigative reporters in 60+ countries. The home of Offshore Leaks.”

A global investigation into medical device harm

Implant Files, video published by ICIJ, 24 November 2018

Patients around the world have become unwitting test subjects for new medical technology. Often following the trusted advice of their doctors, they have been injured, maimed and killed by poorly-tested implants.

Read more about the their implant files investigation.

ICIJ “fights corruption with the world’s best cross-border watchdog journalism by over 160 investigative reporters in 60+ countries. The home of Offshore Leaks”.