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FDA Issues New “Black Box” Warning for Breast Implants

According to a news article posted on mskcc.org, textured implants have been linked to a rare type of cancer called Breast Implant Associated-Anaplastic Large Cell Lymphoma (BIA-ALCL).  The U.S. Food and Drug Administration (FDA) published new safety requirements for breast implants on October 27, 2021.  The FDA placed a “black box” warning on all types […]

Fda issues new “black box” warning for breast implants

Textured Breast Implant Cancer Lawsuits

According to a news article posted on mskcc.org, textured implants have been linked to a rare type of cancer called Breast Implant Associated-Anaplastic Large Cell Lymphoma (BIA-ALCL).  The U.S. Food and Drug Administration (FDA) published new safety requirements for breast implants on October 27, 2021.  The FDA placed a “black box” warning on all types of breast implants in order to notify patients of the potential risks, including Breast Implant-Associated Anaplastic Large Cell Lymphoma, and other symptoms, including joint pain, fatigue, brain fog, memory loss, and tiredness.

The news report states that the FDA’s new safety rules now require manufacturers to sell their breast implants only to medical professionals who review a Patient Decision Checklist of possible risks with their patients prior to breast surgery.

According to reconstructive breast surgeon Dr. Colleen McCarthy, it is crucial that patients understand the risks apply to breast cancer patients.  She stated that patients might have concerns and questions regarding the new guidance.

The goal of the new FDA guidance is to empower patients with facts about breast implant surgery.  The new FDA regulations aren’t based on additional studies but answer the concerns of patients who are planning on breast reconstruction and augmentation surgery utilizing implants.  Patients should be aware that the FDA’s goal is to help patients understand all of the benefits and risks of the surgical procedures and use of breast implants.

Patients who are contemplating breast reconstructive surgery using implants should also be shown with other options such as breast reconstruction using their own tissues or external prosthesis.

The FDA issued warnings against implant use in patients who:

  • Are pregnant or nursing their child;
  • Have an active infection; or
  • Have existing precancer or cancer of the breast tissue;

Textured breast implants have been connected with BIA-ALCL, a rare form of immune system cancer. According to the FDA, the risk is between 1 in 3,000 to 1 in 30,000 patients and the report believes there estimates could be too high.

In 2019, the FDA announced the recall of textured breast implants and expanders manufactured by Allergan.  In its announcement, the FDA affirmed that no implant removal was necessary and that symptoms such as a lump in the breast or armpit, rash, breast swelling, persistent breast pain, or any difference in the implants should be examined by your surgeon. However, these symptoms do not mean the patient has BIA-ALCL.  Some of these symptoms may be the result of trauma to the breast area or a leaking implant.

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If this or any other recalled product has harmed you or a member of your family, contact Parker Waichman LLP to discuss your potential case.  Parker Waichman LLP helps families recover monetary compensation for harm caused by dangerous products. For your free consultation, contact our law firm today by using our live chat or calling 1-800-YOUR-LAWYER (1-800-968-7529).

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