Andrew Sullo is a Top 100 National Trial Lawyer (as named by the National Trial Lawyers 2013-2019).
In July, the FDA asked Allergan to recall its BIOCELL and Natrelle Inspira BIOCELL textured breast implants and tissue expanders. Allergan complied with the request, voluntarily recalling the BIOCELL and Natrelle Inspira BIOCELL textured breast implants on July 24, 2019. According to the FDA, the requested recall was issued as a means of protecting consumers from the increased risk of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). The requested recall was instigated after newly submitted Medical Device Reports showed cases across the globe of BIA-ALCL and BIA-ALCL-related deaths.
The Allergan BIOCELL and Natrelle Inspira BIOCELL breast implants in question have a textured surface, or shell, which is unique, and only used by this particular manufacturer. In fact, as many as 481 BIA-ALCL cases, including 12 deaths, are attributed to the Allergan breast implants. Considering the currently available information, the analysis done by the FDA shows that the risk of BIA-ALCL for those women with BIOCELL and Natrelle Inspira BIOCELL textured implants, is as high as six times the risk of the disease with textured implants from other U.S. breast implant manufacturers.
What is BIA-ALCL? BIA-ALCL is a type of non-Hodgkin’s lymphoma (large cell lymphoma), which is cancer of the immune system. Scar tissue and fluid near the textured breast implants is typically where the BIA-ALCL is found, although in some instances, it can spread throughout the body. A diagnosis of BIA-ALCL is quite serious, and can, for some women, lead to death. Death is more likely when the disease is not diagnosed and treated early on. For many women with textured breast implants who develop BIA-ALCL, the disease can potentially be treated with surgery. Surgery for these patients removes the implant as well as the scar tissue surrounding the implant. Some patients will additionally require radiation and/or chemotherapy.
Symptoms of BIA-ALCL - According to UT Southwestern Medical Center, about one in 30,000 women with a textured-surface breast implant will develop BIA-ALCL. As of February1, 2017, 359 cases of the disease were reported in the United States with nine women dying from the disease. The FDA is not saying that all breast implants are unsafe, only that the recalled Allergan textured breast implants bring a risk of BIA-ALCL to women with those implants. The most common ALCL symptoms include:
- Excessive fluid buildup around the implant;
- Pain surrounding the implant;
- Swelling surrounding the implant;
- Breast enlargement;
- Overlying skin rash;
- Hardening of the breast;
- Lumps in the breast, or
- Lumps in the armpit.
Typically, these symptoms will occur between three and fourteen years following the implantation.
Differences Between Smooth Surface Breast Implants and Textured Surface Breast Implants - Smooth surface implants are most typically used during cosmetic breast surgery, while textured surface implants are more often used during a reconstructive procedure—although the textured surface implants can be used for cosmetic procedures as well. The FDA reports that the ASAPS (American Society for Aesthetic Plastic Surgery, Inc.) estimates at least 550,000 breast implants are placed into women every year. Of this total, only about 13 percent are textured surface implants. Researchers currently believe that the tissue surrounding the breast implant becomes inflamed, the fluid build-up increases, cells are damaged, and cancer develops in the fluid.
Diagnosing BIA-ALCL - As BIA-ALCL progresses, the cancer cells will enter the capsule—a natural covering that the body builds around any foreign object, to protect the surrounding tissue. Once the cancerous cells enter the capsule, they can invade other tissues, including the lymph nodes. Women with breast implants should have annual breast wellness checks, having the fluid surrounding the implant checked. A sample of this fluid will be drawn, then sent to a laboratory to test from CD30, a specific marker which indicates lymphoma.
Remember—it is not all that uncommon for fluid to accumulate around breast implants, and in and of itself, fluid surrounding the implant does not mean you have BIA-ALCL. After three years of removing the textured implant and, in some cases, undergoing cancer treatment, approximately 93 percent of women diagnosed with implant-related BIA-ALCL are disease free (assuming the condition was detected early and treated early).
Disease Reoccurrence Rare Following Removal and Treatment - Breast cancer patients who are considering implant reconstruction should discuss the benefits and risks of the different types of implants with their own physician. There are a great many breast implant options, including smooth or textured, shaped, saline, liquid silicone, and solid silicone. So far, there have been no cases of BIA-ALCL among women with smooth breast implants, only textured implants. Following removal of the textured implant and disease treatment, most patients are closely followed for two years, with PET/CT scans every three-to-six-months. Disease reoccurrence is relatively rare following removal and treatment.
It is extremely important to remember that the FDA is not currently recommending the removal of these Allergan textured implants—or any other breast implants—unless symptoms are present. This is due to the fact that the risk of developing BIA-ALCL is considered to be relatively low. The FDA also asks that women who currently have recalled Allergan textured breast implants speak to their physicians regarding their specific risk of developing BIA-ALCL.
The FDA and the Recalled Allergan Breast Implants - The FDA continues to collect and evaluate information related to Allergan textured breast implants, and the subsequent development of BIA-ALCL. The agency will continue to receive and review medical device reports related to the recalled Allergan breast implants, as well as any other breast implants which could potentially be causing harm or injury. The FDA also reviews data from the Patient Registry and Outcomes for Breast Implants and Anaplastic Large Cell Lymphoma (ALCL). The FDA will also review information from breast implant manufacturers regarding BIA-ALCL and will review information provided from ongoing post-market studies. Those who experience an issue with their Allergan textured implant should use the MedWatch Voluntary Reporting Form to report the issue.
Allergan Textured Breast Implant Lawsuits - According to insider.com, two women filed a class-action lawsuit against Allergan on August 16, 2019. Allergan is a major manufacturer of breast implants. The Allergan breast implant lawsuit follows Allergan’s BIOCELL breast implants being linked to a relatively rare form of cancer, known as breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). The women who filed the class action lawsuit against Allergan stated that if they had been made aware of the potential cancer risk from the Biocell textured implants, they would have chosen a different type of implant, or would have foregone the implants altogether. The women who filed the breast implant class action lawsuit have said that it initially cost them tens of thousands of dollars to get the implants, then they were forced to remove them due to fear of developing BIA-ALCL.
The women involved in the textured breast implant lawsuit are seeking monetary damages for themselves and other women with the implants, on the theory they “will be forced to expend substantial sums for the removal of the recalled implants, surgical and diagnostic fees, and/or medical monitoring and invasive diagnostic procedures required as a result of their exposure to the risk of contracting BIA-ALCL.” Allergan has stated it will cover the costs of new implants for women who received BIOCELL textured implants and want to have them replaced with a smooth implant. Allergan will not, however, pay for surgery costs. This particular program will run from now until July 24, 2021. The textured breast implant lawsuit seeks to cover the costs associated with removing the recalled breast implants, replacing them with a safer alternative.
Allergan Breast Implants Cancer Recall List
At this point, the breast implants which have been recalled include:
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
- 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
Natrelle 410 Highly Cohesive Anatomically Shaped Silicone Filled Breast Implants approved under P040046. The following are the textured styles:
- 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
Allergan tissue expanders for the breast that have BIOCELL texturing originally cleared as:
- Natrelle 133 Plus Tissue Expander (K143354)
- Natrelle 133 Tissue Expander with Suture Tabs (K102806)
Allergan Breast Implants Cancer—Legal Help - If you have experienced problems with your textured breast implants manufactured by Allergan, it could be beneficial to speak to experienced breast implant lawyers who can review the facts of your potential claim, including whether your Allergan implants have caused you to develop large cell lymphoma, ALCL cancer. Whether you have yet experienced ALCL symptoms or not, the Natrelle implants and BIOCELL textured implants which have been recalled could potentially cause you to develop Allergan breast implants cancer. You deserve help during this difficult time, and a qualified breast implant lawyer can answer all your questions regarding whether a textured breast implant lawsuit is right for you.