A recent Health Canada safety advisory comes following an updated safety review of breast implants and the associated risk of BIA-ALCL. According to the April 6, 2022 Health Canada advisory "Advisory - Updated safety review of breast implants underscores the continuing importance of monitoring for cancer; increased risk with highly textured … [Read more...]
FDA Sets New Regulations for Breast Implant Manufacturers
An October 2021 article, "FDA sets stronger safety warnings for breast implants", addresses the Food and Drug Administration's (FDA) new requirements for breast implant manufacturers. The new regulations will require patients receive detailed information about the potential risks and complications of implants prior to receiving surgery. However, … [Read more...]
Philips Ventilators Recall: What The Company Knew and When, What It Did or Did Not Do, and More FDA Findings Released November 2021
This is an important update about the June 2021 Philips ventilators recall using some remarkable findings set forth in an FDA Form 483 issued to Philips Respironics on November 9, 2021. First, from a November 16, 2021 article, "FDA inspection turns up more problems for Philips Respironics", published on the Regulatory Affairs Professionals … [Read more...]
Philips Bi-Level PAP, CPAP, and Mechanical Ventilators Part of Products Recall in June 2021
In connection with a June 2021 Philips products recall, our law firm is investigating possible lawsuits against Philips for patients who have developed cancer or experienced organ failure following toxic exposures from the polyester-based polyurethane (PE-PUR) sound abatement foam component in these recalled Philips products: Philips … [Read more...]
BIA-ALCL Current Recommendations and Potential Future FDA Guidance Changes
History of BIA-ALCL In 2011, the Food and Drug Administration (FDA) reported 34 cases worldwide of Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL), bringing this unique disease into the public eye for the first time. Since then, BIA-ALCL has been recognized internationally as a distinct type of cancer, and prompted the 2019 … [Read more...]
BIA-ALCL Case Studies Confirm Importance of Proper Treatment
Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) is a rare cancer of the immune system. BIA-ALCL has been closely linked with textured surface breast implants. What Causes BIA-ALCL? While BIA-ALCL is rare, it is very serious and potentially fatal if not treated properly. According to this December 2020 article, "Etiology of … [Read more...]
Black Box Warning Label Change for Breast Implants Finalized by the FDA
Since our previous article, “New BIA-ALCL Cases Identified in Updated FDA Report“, the FDA has finalized labeling guidance for breast implant manufacturers. The FDA label change is now requiring a black box label warning for the breast implant devices. In recent years, many textured breast implants have been linked to BIA-ALCL (breast … [Read more...]
New BIA-ALCL Cases Identified in Updated FDA Report
Since our previous article, "Most American Women Are Unaware of BIA-ALCL", the FDA has released an update on reports of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). The update includes new BIA-ALCL case reports through January 5, 2020. What's New in BIA-ALCL Cases? Currently, the FDA analysis of global medical device … [Read more...]
Most American Women Are Unaware of BIA-ALCL
Since our previous article, Allergan Aesthetics Launches Tracking Campaign for U.S. Breast Implant Patients, recent news articles report the majority of American women are unaware of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). Studies on BIA-ALCL Knowledge According to a July 2020 Practice Update article, 500 women … [Read more...]
Allergan Aesthetics Launches Tracking Campaign for U.S. Breast Implant Patients
Since the July 2019 voluntary recall of textured breast implant Biocell, pharmaceutical company Allergan has been under fire. The recall came after research linked the implant with cases of breast implant associated anaplastic large cell lymphoma (BIA-ALCL). Allergan plans to launch a tracking campaign for U.S. breast implant patients in the near … [Read more...]
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