Allergan announced it is voluntarily recalling those textured breast implants under pressure from the U.S. Food and Drug Administration (FDA). Textured implants have been linked to a rare form of cancer known as breast implant–associated anaplastic large cell lymphoma (BIA-ALCL) and implicated in 33 deaths. Twelve out of the 13 deaths in which the specific manufacturer was known were in patients who had Allergan implants at the time they were diagnosed. The Allergan implants were banned in Canada in May and pulled from the European market in December 2018. Contact a Breast Implant Allergan Recall Lawyer at Shamis & Gentile, P.A. today if you believe you have a breast implant induced injury case.
The products included in the recall are:
- Natrelle Saline-Filled breast implants
- Natrelle Silicone-Filled breast implants
- Natrelle Inspira Silicone-Filled breast implants
- Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Filled breast implants
The recall also includes tissue expanders. These are balloon-like sacs that are slowly expanded with salt-water to stretch the skin so the permanent implant can be inserted later. They include:
- Natrelle 133 Plus Tissue Expander
- Natrelle 133 Tissue Expander with Suture Tabs
The Allergan recall does not mean all women with these implants should have them removed. The FDA says the surgery is not worth the risk unless a woman is having symptoms. Signs and symptoms of BIA-ALCL may include lumps, pain, swelling, and asymmetry (breasts look different from each other).
Understanding BIA-ALCL and Breast Implant Illness
BIA-ALCL is a cancer of the immune system, not a form of breast cancer, that develops in the scar tissue and fluid around a breast implant.
Silicone breast implants generally come in two categories: textured and smooth, which refers to differences in the shell surrounding the gel on the inside
The texturing on the shell of the implant interfaces with the surrounding breast tissue. It’s predicted that either a mechanical or a bacterial contamination of this textured cell stimulates tissue growth. Anytime there is tissue growth, there is also potential for abnormal tissue growth.
BIA-ALCL is different from “breast implant illness,” a broad umbrella term sometimes used to describe symptoms ranging from pain and fatigue to autoimmune complications. Right now, that is not a recognized medical diagnosis.
What Are Experts and the FDA Advising for Women With Textured Implants?
The implants will no longer be sold and healthcare providers should no longer use them, the FDA said in its announcement of the voluntary recall last week.
While evidence suggests that removing the implants leads to recovery in many, though not all, women who develop BIA-ALCL, the FDA is not currently recommending removal for women who do not have symptoms of the cancer, like pain and swelling around the implant site. According to the FDA, determining whether a woman has developed BIA-ALCL typically involves a physical examination, imaging, and testing the fluid or tissue around the implant.
Shamis & Gentile, P.A. Investigates Breast Implant Allergan Recall
Shamis & Gentile, P.A. is now investigating cases related to breast implant illness (BII) and women who have developed breast implant–associated anaplastic large cell lymphoma (BIA-ALCL). There has been a formal recall as it relates to individuals with implants made by Allergan, Inc. Any implants made by Allergan (or other “textured” models) will most likely immediately qualify for representation. This type of litigation will fall into the category of a “mass tort” and will require individuals seeking compensation to directly sign up with a Breast Implant Allergan Recall attorney. This is not a class action where a claim can be made after litigation has concluded. The type of compensation that might be available are medical bills, lost wages, and pain and suffering.
Contact a Breast Implant Allergan Recall Lawyer at Shamis & Gentile, P.A.
Contact a Breast Implant Allergan Recall Lawyer at Shamis & Gentile, P.A. today if you believe you have a breast implant induced injury case. If you or somebody you know has been diagnosed with side effects of silicone breast implants, you should contact our lawyers immediately for a free case consultation. Please fill out a form to contact our Defective Medical Device Litigation Group. Call us at 305-479-2299 or Text Us About It at 1-833-3-TEXT-ME (1-833-383-9863).