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BIA-ALCL Current Recommendations and Potential Future FDA Guidance Changes

April 21, 2021 By Law Offices of Thomas J. Lamb, P.A.

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...]

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 cancers, breast implants lawsuits, breast implants lymphoma cancers, breast implants side effects, FDA, textured breast implants

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

FDA Recalls Allergan Textured Implants

July 26, 2019 By Law Offices of Thomas J. Lamb, P.A.

We have consistently provided updates on the situation of Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) in relation to textured implants.  Every article prior to this one has discussed how other countries have banned textured breast implants or how the FDA has been monitoring the issue.  As of July 24, 2019 the FDA has finally … [Read more...]

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

Allergan Textured Breast Implants Recalled In Europe Due To BIA-ALCL

January 7, 2019 By Law Offices of Thomas J. Lamb, P.A.

In December 2018 France’s National Agency for the Safety of Medicines and Health Products (ANSM) announced that Allergan textured breast implants can no longer be marketed in France and elsewhere in Europe. As regards what the FDA is doing on this developing medical device safety issue, we turn to this NBC News piece, “Allergan’s textured breast … [Read more...]

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

Several 2018 Breast Implant Lymphoma Cancer Lawsuits Already Filed

May 3, 2018 By Law Offices of Thomas J. Lamb, P.A.

Background Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) is a type of non-Hodgkin's lymphoma, which is a cancer of the cells of the immune system.  This rare T-cell lymphoma can develop as a result of breast implants, though the mechanism of injury is not fully understood at this time.  However, based on current data from the … [Read more...]

Filed Under: Unsafe Medical Devices Tagged With: allergan breast implants, BIA-ALCL, breast implant-associated anaplastic large cell lymphoma, breast implants BIA-ALCL, breast implants cancers, breast implants lawsuits, breast implants lymphoma cancers, mentor breast implants

FDA Provides Updated Number of Breast Implants Lymphoma Cancers

March 21, 2018 By Law Offices of Thomas J. Lamb, P.A.

About BIA-ALCL The U.S. Food and Drug Administration (FDA) has been aware of the possible connection between breast implants and breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) since 2011. This condition is a rare type of non-Hodgkin’s lymphoma, which is a cancer of the immune system, rather than a cancer of the breast … [Read more...]

Filed Under: Unsafe Medical Devices Tagged With: allergan breast implants, BIA-ALCL, breast implant-associated anaplastic large cell lymphoma, breast implants BIA-ALCL, breast implants cancers, breast implants lawsuits, breast implants lymphoma cancers, mentor breast implants

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