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BREAST IMPLANT LINKED TO RARE FORM OF CANCER
On July 24, 2019, the FDA took a significant and somewhat rare step in requesting that Allergan, the manufacturer of textured breast implants, recall specific models from the US market due to a heightened risk of a rare form of cancer.
- 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
A complete list of the Affected Products can be found at the bottom of the article.
The recall also includes tissue expanders used by patients before breast implant surgery or reconstruction including:
- Natrelle 133 Plus Tissue Expander
- Natrelle 133 Tissue Expander with Suture Tabs
WHY WERE THE BREAST IMPLANTS RECALLED?The FDA requested that Allergan recall all textured breast implants and tissue expanders based on numerous reports showing cases of cancer called breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). A worldwide total of 573 BIA-ALCL cases also included 33 patient deaths. Of the 573 cases of BIA-ALCL, 481 were reported to have Allergan breast implants at the time of diagnosis (almost 84%). In addition, 12 of 13 deaths occurring in patients with BIA-ALCL where the manufacturer was known occurred in patients implanted with Allergan breast implants at the time of their diagnosis. The manufacturer on the other 20 deaths was unknown. Based on this information, the FDA’s analysis showed that the risk of BIA-ALCL with Allergan’s textured implants is approximately 6X the risk of BIA-ALCL with textured implants from other manufacturers.
WHAT IS BIA-ALCL?Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) is not breast cancer. It is a type of non-Hodgkin’s lymphoma (cancer of the immune system). In most cases, BIA-ALCL is found in the scar tissue and fluid near the implant, itself. In some cases, however, it can spread throughout the body. According to the FDA, the overall likelihood of actually getting BIA-ALCL is considered to be low, BUT, a BIA-ALCL diagnosis is very serious and can lead to death, especially if not diagnosed early or promptly treated. According to the FDA, in most patients, BIA-ALCL is treated successfully with surgery to remove the implant and scar tissue surrounding the implant. Some patients may require treatment with chemotherapy and/or radiation therapy.
WHAT SHOULD I DO?Women with breast implants that have been diagnosed with cancer – particularly BIA-ALCL – should contact a breast implant recall lawyer immediately to discuss their legal rights and options. Our team of experienced staff and attorneys have litigated thousands of cases against medical device and pharmaceutical manufacturers across the United States.
WHAT IF I DON’T HAVE CANCER, BUT AM STILL CONCERNED?Currently, the FDA stated that if you have no symptoms, the FDA is not recommending the removal of these or other types of breast implants. However, if you have questions, you should immediately talk to your health care provider.
WHAT ARE THE SIGNS AND SYMPTOMS OF BIA-ALCL?Persistent swelling or pain near the breast implant are the primary signs. The FDA recommends that you monitor the area around your breast implant for any changes. If you experience any of these symptoms or changes, you should immediately contact your health care provider regarding the need for further evaluation. Evaluation for BIA-ALCL typically involves a physical exam, imaging, and/or assessment of the fluid or tissue around the breast implant. It is important to undergo an evaluation to diagnose BIA-ALCL since a confirmed BIA-ALCL diagnosis may change the type of operation that is performed.
HOW DO I KNOW WHAT BRAND OR MODEL OF BREAST IMPLANT I HAVE?As with any implanted device, it is good to keep a record of the device manufacturer and implant model name. You should have received this information on a patient device card from your surgeon. If you don’t have the information readily available, your surgeon and the operative notes he or she took should contain this information. Our team of lawyers and staff are ready to assist any of our clients with finding this information.
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BREAST IMPLANT RECALL – AFFECTED PRODUCTSAllergan 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
- 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
- Style TRLP – Natrelle Inspira BIOCELL Textured Responsive Silicone-Filled Breast Implants
- Style TRM – Natrelle Inspira BIOCELL Textured Responsive Silicone-Filled Breast Implants
- Style TRF – Natrelle Inspira BIOCELL Textured Responsive Silicone-Filled Breast Implants
- Style TRX – Natrelle Inspira BIOCELL Textured Responsive Silicone-Filled Breast Implants
- Style TCL – Natrelle Inspira BIOCELL Textured Cohesive Silicone-Filled Breast Implants
- Style TCLP – Natrelle Inspira BIOCELL Textured Cohesive Silicone-Filled Breast Implants
- Style TCM – Natrelle Inspira BIOCELL Textured Cohesive Silicone-Filled Breast Implants
- Style TCF – Natrelle Inspira BIOCELL Textured Cohesive Silicone-Filled Breast Implants
- Style TCX – Natrelle Inspira BIOCELL Textured Cohesive Silicone-Filled Breast Implants
- Style TSL – Natrelle BIOCELL Textured Soft Touch Silicone-Filled Breast Implants
- Style TSLP – Natrelle BIOCELL Textured Soft Touch Silicone-Filled Breast Implants
- Style TSM – Natrelle BIOCELL Textured Soft Touch Silicone-Filled Breast Implants
- Style TSF – Natrelle BIOCELL Textured Soft Touch Silicone-Filled Breast Implants
- Style TSX – Natrelle BIOCELL Textured Soft Touch Silicone-Filled Breast Implants
- Style 410FM
- Style 410FF
- Style 410MM
- Style 410 MF
- Style 410 FL
- Style 410 ML
- Style 410 LL
- Style 410 LM
- Style 410 LF
- Style 410 FX
- Style 410 MX
- Style 410 LX
- Natrelle 133 Plus Tissue Expander (K143354)
- Natrelle 133 Tissue Expander with Suture Tabs (K102806)
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