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.” …
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.
Press release. Video published on 7 March 2019 by Kaiser Health News.
One day after my @KHNews report on more than a million medical device reports going into an internal database, notably surgical staplers, the #FDA announces a sweeping plan to review stapler safety — and the hidden reports: https://t.co/JgEwL7zzIc via
This number is staggering: more than 1.1 million incidents of medical device related injuries and malfunctions since 2016 have been kept hidden from public view in the FDA's "alternative summary reporting" database. Powerful investigation by @By_CJewetthttps://t.co/VZs1RQA1Zy
The #FDA warned of complications re: pelvic #mesh in 2011. Then FDA granted lawsuit 'exemptions' to 8 mesh makers to file summary reports. The 2017 total? 11,969 mesh injuries submitted via spreadsheet to FDA, bypassing the public and MDs – https://t.co/9K7nDwBITX via @KHNews
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.