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Black Box Warning Label Change for Breast Implants Finalized by the FDA

October 23, 2020 By Law Offices of Thomas J. Lamb, P.A.

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...]

Filed Under: Unsafe Medical Devices Tagged With: allergan breast implants, breast implant-associated anaplastic large cell lymphoma, breast implants, breast implants BIA-ALCL, breast implants lymphoma cancers, medical devices adverse effects, textured breast implants

New BIA-ALCL Cases Identified in Updated FDA Report

August 28, 2020 By Law Offices of Thomas J. Lamb, P.A.

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...]

Filed Under: Unsafe Medical Devices Tagged With: allergan breast implants, breast implant-associated anaplastic large cell lymphoma, breast implants, breast implants BIA-ALCL, breast implants lymphoma cancers, medical devices adverse effects, textured breast implants

Most American Women Are Unaware of BIA-ALCL

July 22, 2020 By Law Offices of Thomas J. Lamb, P.A.

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 … [Read more...]

Filed Under: Unsafe Medical Devices Tagged With: allergan breast implants, breast implant-associated anaplastic large cell lymphoma, breast implants, breast implants BIA-ALCL, breast implants lymphoma cancers, medical devices adverse effects, textured breast implants

Allergan Aesthetics Launches Tracking Campaign for U.S. Breast Implant Patients

June 24, 2020 By Law Offices of Thomas J. Lamb, P.A.

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...]

Filed Under: Unsafe Medical Devices Tagged With: allergan breast implants, breast implant-associated anaplastic large cell lymphoma, breast implants, breast implants cancers, medical devices adverse effects, textured breast implants

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