You never want to see the words “breast implant” and “cancer” next to each other in a headline. But such news stories have been circulating recently after the Food and Drug Administration (FDA) requested that a manufacturer voluntarily recall certain kinds of textured breast implants connected to a rare kind of cancer. “The U.S. Food and Drug Administration today took significant action to protect women from breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) by requesting that Allergan, the manufacturer of a specific type of textured implant, recall specific models of its textured breast implants from the U.S. market due to the risk of BIA-ALCL,” the FDA’s July 24 release reads. Contact a textured breast implants lawsuit Allergan Recall Lawyer today at Shamis & Gentile, P.A.
What exactly was recalled?
The idea of breast implants potentially causing cancer is genuinely scary, even more so for anyone who has them (or is thinking about getting them). Here’s everything you need to know about the recall, including the kind of cancer it’s been connected to and what to do if you have breast implants.
This recall applies to BIOCELL textured breast implants and tissue expanders (devices used to stretch a person’s skin before breast augmentation or reconstruction after a mastectomy) from Allergan.
BIOCELL refers to a unique type of macro-textured surface that only Allergan uses in its products, the FDA explains. The recall covers all styles of Allergan’s BIOCELL textured breast implants, including both silicone and saline-filled ones. It also includes BIOCELL tissue expanders (which are also macro-textured), the FDA explains.
Affected Products
Allergan Natrelle Saline-Filled Breast Implants (formerly McGhan RTV Saline-Filled Mammary Implant) approved under P990074. The following are the textured styles:
- Style 163 – BIOCELL Textured Shaped Full Height, Full Projection Saline Breast Implants
- Style 168 – BIOCELL Textured Round Moderate Profile Saline Breast Implants, also referred to as 168MP (168 Moderate Profile)
- Style 363 – BIOCELL Textured Shaped Moderate Height, Full Projection Saline Breast Implants, Allergan catalog includes 363LF, or 363 Low Height Full Projection
- Style 468 – BIOCELL Textured Shaped Full Height Moderate Projection Saline Breast Implants
Allergan Natrelle Silicone-Filled Textured Breast Implants (formerly Inamed Silicone-Filled Breast Implants) approved under P020056. The following are the textured styles:
- Style 110 – BIOCELL Textured Round Moderate Projection Gel Filled Breast Implants
- Style 115 – BIOCELL Textured Round Midrange Projection Gel Filled Breast Implants
- Style 120 – BIOCELL Textured Round High Projection Gel Filled Breast Implants
- Style TRL – Natrelle Inspira BIOCELL Textured Responsive Silicone-Filled Breast Implants
- You can find a complete list of recalled products at the bottom of the FDA’s safety communication here.
What is the link between these implants and cancer?
The potential connection between breast implants and breast implant-associated anaplastic large cell lymphoma is not new.
The FDA first publicly noted the potential connection back in 2011 in a safety update on breast implants. But with only 60 reported cases worldwide, the agency didn’t have enough data to establish a link. Over the past eight years, the FDA has been monitoring the accumulating data and sharing updates. In February 2019, the FDA issued a statement with more information about BIA-ALCL but didn’t yet issue a request for a recall.
The tipping point that prompted them to do so was the 116 new unique cases and 24 deaths that have come to the agency’s attention since then. (A unique case means the cancer was in only one breast. In a couple of instances, patients had BIA-ALCL in both breasts, which counted as two cases.) In total, the agency now knows of 573 unique cases globally and 33 patient deaths from BIA-ALCL.
What is BIA-ALCL, exactly?
Since all of this is so unnerving, a disclaimer first: BIA-ALCL is a rare, slow-growing cancer that will never impact most people with breast implants.
As for BIA-ALCL characteristics, even though it occurs in the breast area, it isn’t actually breast cancer. Instead, it’s a type of non-Hodgkin’s lymphoma, or cancer of the immune system, the FDA explains, that begins around the implant. Usually, it occurs not within the actual tissue of the breast, but in that fibrous scar capsule we mentioned that forms around the implant, or in the fluids inside that capsule called the seroma. In some cases, if it becomes advanced, BIA-ALCL can spread to the lymph nodes nearby and, more rarely, throughout the body, according to the Cleveland Clinic.
Do I Have a Textured Breast Implants Lawsuit
Contact us for a free, no obligation legal consultation. If your case is not one that can be immediately signed up for representation we would still like to keep you involved and updated with any relevant new legal information that may be of your benefit in this very new area of litigation. It is our intention to investigate all legal remedies for all women suffering from Breast Implant Illness (BII), regardless of the model of implant, as more details emerge regarding the textured breast implants lawsuit for Allergan products.
Textured Breast Implants Lawsuit | Contact Shamis & Gentile, P.A.
Contact the Breast Implant Illness Lawyers 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 textured breast implants lawsuit 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).
