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Allergan Breast Implants and Cancer BIA-ALCL

Medical Malpractice

Allergan Breast Implants and Cancer BIA-ALCL

Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) is a rare type of T-cell lymphoma (cancer of the immune system) that can develop in the scar tissue capsule and fluid surrounding a breast implant. In some cases, it can spread throughout the body.

BIA-ALCL is curable in most patients if it’s diagnosed early and treated appropriately, but a small number have died from the illness.

BIA-ALCL is not breast cancer. It can occur around saline-filled or silicone gel-filled implants that have been placed for breast reconstruction after mastectomy or cosmetic breast enlargement. BIA-ALCL seems to only develop in women who have implants with a textured surface (shell) or had them in the past.

All patients have rights and need to be educated and forewarned about the risks associated with implanting anything in their bodies. Accountability on behalf of the manufacturing companies needs to be addressed so they can be held responsible.

Summary

Often occurring eight to 10 years after surgery, symptoms of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) include pain and swelling near the implant. Women with textured breast implants (as opposed to smooth) are at an increased risk of developing BIA-ALCL.

What does the FDA know about Breast Implant Associated Lymphoma?

The FDA first identified a possible association between breast implants and the development of ALCL in 2011. At that time, the FDA knew of so few cases of this disease that it was not possible to determine what factors increased the risk. In a report summarizing the Agency’s findings, we emphasized the need to gather additional information to better characterize ALCL in individuals with breast implants. In 2016, the World Health OrganizationExternal Link Disclaimer designated breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) as a T-cell lymphoma that can develop following breast implants and noted that the exact number of cases remained difficult to determine due to significant limitations in world-wide reporting and lack of global breast implant sales data.

Since that time, the FDA has undertaken several steps to better understand this issue, including an in-depth review of post-approval study data, medical device reports, scientific literature and breast implant-specific registries, and public discussions. We have regularly communicated about the risks associated with breast implants and heard from patients who are concerned about their implants being connected to various health conditions. In March 2019, we discussed many important breast implants concerns in a public advisory committee meeting.

This is why you need representation from a PROFESSIONAL MEDICAL MALPRACTICE Lawyer.

Were you implanted with Allergan BIOCELL or Natrelle textured breast implants?

BIAALCL has occurred in at least four transgender women who had textured breast implants. The number of BIAALCL cases reported in July 2019 led to a global recall of Biocell textured breast implants and tissue expanders manufactured by Allergan.

Allergan Breast Implant Recalls

In July 2019, Allergan recalled its Biocell textured breast implants after the FDA had linked them to a rare cancer called breast implant-associated anaplastic large cell lymphoma, or BIA-ALCL. Most of Allergan’s recalled textured breast implants were sold under the Natrelle brand. The FDA advises women with BIA-ALCL to have their implants removed.

Allergan’s July 2019 Biocell textured breast implant recall doesn’t include its smooth or Microcell breast implants or tissue expanders, which have a much smaller risk of BIA-ALCL. The recalled breast implants represent less than 5 percent of implants sold in the United States. The FDA has not released the exact number of implants affected.

But since then, the number of confirmed cases of BIAALCL has grown.Feb. 25, 2020

What Is BIA-ALCL? – Breastcancer.org

You may be at risk for developing cancer, the textured surface of implants can trigger an increase response from immune cells over time.

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