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The FDA Takes Action to Protect Patients from Risk of Certain Textured Breast Implants

On Behalf of | Jul 30, 2019 | FDA Alerts

In response to the risk of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) linked to Allergan BIOCELL textured breast implants, the Food and Drug Administration (FDA) has requested that Allergan voluntarily recall select breast implants and tissue expanders. As a result of the request for recall, Allergan has agreed to take its products associated with increased lymphoma risks off the market. Here, the Baltimore medical device liability attorneys at The Law Offices of Peter Angelos discuss the details surrounding the risks associated with Allergan BIOCELL textured breast implants and how the FDA is taking measures to protect patients who may be affected.

BIA-ALCL is a Rare but Serious Form of Non-Hodgkin’s Lymphoma

BIA-ALCL is a form of non-Hodgkin’s lymphoma associated with receiving breast implants and most often occurs in the scar tissue and fluid near the implant. In serious cases, the cancer can spread throughout the body and lead to death if not detected or treated immediately. Unlike breast cancer, BIA-ALCL is a cancer of the immune system that can be treated with the removal of the implant and surrounding scar tissue if diagnosed in its early stages. While a rare form of cancer, BIA-ALCL should be taken as a serious concern when receiving textured breast implants.

A Large Number of Reported BIA-ALCL Cases Occurred in Individuals with Allergan Breast Implants

Out of a recent global reported total of 573 cases of BIA-ALCL, 481 patients reported to have Allergan BIOCELL breast implants. Based on this information, the FDA has concluded that Allergan BIOCELL breast implants increase the risk of developing BIA-ALCL by six times compared to breast implants from other manufacturers. Out the 13 reported BIA-ALCL-related deaths where the breast implant manufacturer was known, 12 of the reported deaths occurred in patients with Allergan breast implants.

Allergan Has Agreed to Remove BIOCELL Products From the Market

As a result of recent Medical Device Reports (MDRs) and the FDA’s analysis of the link between BIA-ALCL-related deaths and Allergan BIOCELL products, Allergan has informed the FDA that it will recall its BIOCELL products including BIOCELL textured breast implants and tissue expanders from the global market. It is imperative that patients who have undergone surgery to receive Allergan BIOCELL textured breast implants or tissue expanders stay cognizant of the increased risks of developing BIA-ALCL. If you experience any symptoms of BIA-ALCL, including swelling or pain in the area near your breast implants, contact your primary health care professional immediately.

Consult the Team of Medical Device Liability Attorneys at The Law Offices of Peter Angelos Today

The dedicated team of Baltimore medical device liability attorneys at The Law Offices of Peter Angelos urge you to be aware of the unsettling link between Allergan BIOCELL products and BIA-ALCL and seek medical attention if you notice signs and symptoms of this rare but life-threatening form of non-Hodgkin’s lymphoma. At the Law Offices of Peter Angelos, our attorneys strive to provide victims of medical device liability with the legal counsel they need and deserve. If you or a loved one was diagnosed with BIA-ALCL after receiving Allergan BIOCELL textured breast implants or tissue expanders and wish to pursue legal action, contact The Law Offices of Peter Angelos today.