Allergan Breast Implants Cancer: Breast Implant Recall Questions

Andrew Sullo is a Top 100 National Trial Lawyer (as named by the National Trial Lawyers 2013-2019).

What are the Injuries Caused by Allergan Breast Implants? It is now believed that Allergan textured breast implants have been linked to a rare, sometimes deadly form of cancer known as BIA-ALCL. This breast implant-associated anaplastic large cell lymphoma is a form of cancer associated with textured breast implants. Because BIA-ALCL can take many years to develop, women who have the disease may not yet be aware of it. The BIA-ALCL is found in the scar tissue and fluid around breast implants, and while it is not breast cancer, it does arise from breast tissue immune cells, specifically T-cells. To this date, every BIA-ALCL case reported has been in women who either have a textured breast implant or have had a textured implant in the past. As noted, BIA-ALCL is found near the breast implant, usually contained within the fibrous scar capsule, rather than in the breast tissues.

What are the Symptoms Associated with Allergan Large Cell Lymphoma? While BIA-ALCL is not breast cancer, it does develop around the breast and the textured implant and is considered a slow-growing type of non-Hodgkin’s lymphoma or a disorder of the immune system. The primary system associated with BIA-ALCL is painless swelling of the breast, however once the disease has progressed, a woman can experience pain surrounding the implant, lumps in the breast, lumps in the underarm, and swelling around the implant.

About half of all cases of BIA-ALCL have been diagnosed within seven to eight years following implantation of the Allergan textured breast implant. According to the American Society of Plastic Surgeons, however, symptoms can appear from two to 28 years following the procedure. Because breast swelling following an implant can also be caused by an infection or the rupture of the breast implant, it is important that you seek medical attention if you experience any changes at all.

The FDA believes that, in most cases, this type of lymphoma cancer is contained to the fluids and scar tissue near the implant, however BIA-ALCL can spread throughout the body. A diagnosis of BIA-ALCL can require chemotherapy and/or radiation, and, in rarer cases, can lead to death. Some women have also experienced gastrointestinal symptoms after having a textured breast implant device implanted, as well as infections in the area.

Did the FDA Order a Recall of the Allergan Textured Breast Implants? As far back as 2011, the FDA identified a potential association between breast implants and the development of ALCL. Five years later breast implant-associated anaplastic large cell lymphoma was designated as a t-cell lymphoma by the World Health Organization. This t-cell lymphoma can develop following implantation of a textured breast implant. Since that time, the FDA conducted an in-depth review of post-approval study data on the implants in question to determine the potential for danger among women with these textured breast implants. It was not until the end of July that the FDA asked Allergan to recall the Natrelle and BIOCELL textured breast implants and tissue expanders. Physicians were asked to stop implanting the Natrelle and BIOCELL textured implants, and to return any inventory of the recalled implants to Allergan. 

What Makes Textured Breast Implants Dangerous? There has been between 481 and 573 cases of BIA-ALCL, including 35 deaths. Twelve of those deaths were directly tied to Allergan textured breast implants. It is believed that the texture of the shell surrounding the implant is the culprit in these cases of BIA-ALCL. The textured-surface breast implants cause the body’s lymphoma response to kick in, resulting in inflammation surrounding the Allergan textured breast implant. BIA-ALCL attacks the immune system and may not be diagnosed for a number of years following implantation. The FDA has stated that women with a recalled textured Allergan breast implant has six times the risk of developing BIA-ALCL as they would if they had been implanted with a similar product sold by other manufacturers. It is believed that between ten to thirteen percent of all breast implants across the globe are the textured type. Smooth breast implants are usually used for cosmetic purposes, while textured breast implants are more often used in reconstructive breast surgeries.

Is BIA-ALCL the Only Cancer Associated with Textured Breast Implants? So far, BIA-ALCL is the only cancer associated with these recalled Allergan textured breast implants. BIA-ALCL is a form of non-Hodgkin’s lymphoma and is also known as anaplastic lymphoma, anaplastic large cell lymphoma, anaplastic t-cell lymphoma, ALCL lymphoma, and anaplastic large t-cell lymphoma. The lifetime risk of a woman with an Allergan textured breast implant developing this disease is between one in 3,817 and one in 30,000. While the FDA is not recommending having your textured breast implant removed unless you have BIA-ALCL lymphoma symptoms or have been diagnosed with the disease. Although textured implants are mostly used for reconstructive surgical purposes, in the United States, 56 percent of cases of BIA-ALCL patients had the textured implant for cosmetic reasons.

Should I Have My Allergan Textured Breast Implant Removed? As noted, the FDA does not necessarily recommend having your recalled textured breast implant removed unless and until you have issues related to the Allergan breast implant. That being said, this decision should be made based on a conversation between yourself and your physician. You should immediately let your physician know whether you have had any symptoms related to your Allergan textured breast implant. Your physician can perform certain tests to determine whether BIA-ALCL is present in your body. You may also want to have your Allergan textured breast implant removed simply because you do not want to wait and see if you develop the disease. In any case, this is a decision only you can make.

Has There Been a Breast Implant Class Action Lawsuit? In 2018, women filed a breast implant class action lawsuit against Allergan in New Jersey and in California. More recently, two women have filed a new breast implant class action lawsuit against Allergan, claiming the company’s textured breast implants gave them a rare form of cancer. One of the women claims she began having symptoms of BIA-ALCL in February 2019, while the other woman received BIOCELL textured implants in 2016 and has since been diagnosed with BIA-ALCL.

Are There Individual Textured Breast Implant Lawsuits? Lawyers across the country believe that since the Allergan breast implant recall was issued, there will be many individual textured breast implant lawsuits filed in the coming months. If you have been diagnosed with BIA-ALCL, or have symptoms of the disease after receiving a recalled Allergan textured breast implant, you may want to consider joining in an Allergan breast implant class action lawsuit or having breast implant lawyers file an Allergan textured breast implant lawsuit on your behalf.

Will There Be a Breast Implant Lawsuit Settlement? We are unlikely to hear of a breast implant lawsuit settlement for many months, or even years. Allergan will first wait to see how many textured breast implant lawsuits will be filed against the corporation, then will wait to see the results of the first few lawsuits heard. If the textured breast implant lawsuits which are heard are not decided in favor of Allergan, the company may decide to implement a breast implant lawsuit settlement.

How Can Breast Implant Lawyers Help Those Affected by the Recall? The knowledgeable breast implant lawyers at Sullo & Sullo can help you determine whether an Allergan breast implant lawsuit is in your best interests. It is likely you have many questions related to the Allergan textured breast implant recall. Call Sullo & Sullo today to have those questions answered, and to discuss your options.

Which Allergan Breast Implants are Involved in the Recall? 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)
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