Allergan Breast Implants Cancer: Allergan Breast Implant Recall

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

What are the Issues with Allergan Breast Implants? Allergan textured breast implants have been linked to breast implant-associated anaplastic large cell lymphoma—a type of large t-cell lymphoma. BIA-ALCL attacks the immune system and is normally not diagnosed for a number of years following implantation. While it is not completely clear why textured implants can result in this type of cancer, it is theorized that the texture of the shell surrounding the implant could cause the lymphoma response in the capsule tissues which surround the implant.

While the FDA believes the lymphoma cancer is largely limited to the fluids and scar tissue surrounding the implant, it can spread to the lymph nodes—and throughout the body. A diagnosis of BIA-ALCL is serious; many patients will require chemotherapy and/or radiation, and the diagnosis can potentially lead to death. In fact, the FDA claims that the risk of getting BIA-ALCL from an Allergan textured breast implant is six times the risk of getting the same cancer from a similar product sold by other manufacturers. (Allergan is, however, the only manufacturer who markets a textured breast implant like the ones being recalled).

Most women who are undergoing cosmetic surgery will receive a smooth breast implant, while the textured implants were largely used for those undergoing reconstructive surgery. Anaplastic large cell lymphoma symptoms include pain around the implant, swelling around the implant, lumps in the armpit and lumps in the breast. Symptoms of ALCL typically occur between three to fourteen years following the placement of the implant.

Allergan Breast Implants Cancer and the FDA - The FDA first identified a possible association between breast implants and the development of ALCL in 2011. At that specific time, there were few cases of BIA-ALCL, which is a form of non-Hodgkin’s lymphoma. Because there were so few cases, it was impossible at that time to determine the actual risk to women with breast implants. Five years later, the World Health Organization designated breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) as a t-cell lymphoma.

This t-cell lymphoma can develop following the implantation of breast implant devices, however noted it was difficult to secure an exact number of the cases because of a lack of global breast implant sales data, as well as certain limitations regarding world-wide reporting. Since 2016, the FDA has taken steps (including an in-depth review of post-approval study data for the breast implants in question, certain medical device reports, public discussions, breast implant registries and scientific literature) to accurately determine the potential dangers of textured breast implants.

In a March 2019 meeting held by the FDA, many important textured breast implant concerns were discussed in a public advisory committee meeting. At that time, the FDA determined there was not sufficient evidence heard at the meeting to ask for a recall of the textured breast implants manufactured by Allergan (BIOCELL and Natrelle). Since that time, more data has been gathered by the FDA, leading to the agency to ask Allergan to recall the textured breast implants in question.  

A July 24, 2019 FDA Safety Communication stated that physicians should immediately cease implanting these specific breast implants and tissue expanders, working with Allergan to return any existing inventory. At that time the FDA stated they were not recommending the routine removal of these breast implants among patients with no symptoms, but that patients with the listed textured implants and tissue expanders should be informed of the potential risks—including the development of BIA-ALCL. On February 12, 2019, Health Canada announced an external link disclaimer stating it would be updating its safety review of breast implants. 

On April 4, 2019, the French National Agency for Medicines and Health Products Safety announced its decision to withdraw textured breast implants marketed in France. On July 11, 2019, The Australian Therapeutic Goods Administration proposed regulatory actions regarding textured breast implants.  As of August 2019, the FDA asked Allergan to recall certain Allergan textured breast implants, including Natrelle and BIOCELL (full list below). Allergan issued the recall only after the FDA published its report on the potential dangers of the Allergan textured breast implants.

The BIOCELL and Natrelle textured saline-filled and silicone-filled textured breast implants and textured expanders will no longer be distributed or sold in any market where they are currently available. This recall means no textured Allergan implants listed on the recall should be implanted, and all current stock of these implants should immediately be returned to Allergan. According to the FDA, these textured-surface Allergan breast implants are potentially tied to 481 cases of BIA-ALCL—a type of non-Hodgkin’s lymphoma. Across the world, there have been 573 cases of ALCL potentially tied to breast implants, including 12 deaths directly associated with Allergan textured breast implants.

Getting Help from Experienced Breast Implant Lawyers for an Allergan Breast Implant Lawsuit - If you have an Allergan Natrelle or BIOCELL textured breast implant and have experienced issued related to these textured breast implants, you may consider breast implant litigation. A class action lawsuit against Allergan has already been filed by two women, and many more are expected to join in this lawsuit as well as individual breast implant lawsuits in the coming months. Because the Allergan textured breast implants have been recalled, the door has been opened to Allergan breast implant lawsuits.

If you have one of the Allergan breast implants listed below, it could be extremely beneficial for you to speak to the experienced breast implant lawyers at the Houston law firm of Sullo & Sullo. We can help you determine whether an Allergan breast implant lawsuit is in your best interests. In the event there is a breast implant lawsuit settlement, we can ensure you are part of that settlement. Contact the knowledgeable breast implant lawyers at Sullo & Sullo today.

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)
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