Andrew Sullo is a Top 100 National Trial Lawyer (as named by the National Trial Lawyers 2013-2019).
The Issue with Allergan Breast Implants - Very recently the U.S. Food and Drug Administration issued a recall of breast implants which were produced by the pharmaceutical company, Allergan. The recall was issued because of an increased risk of cancer among women with certain Allergan implants. The FDA found that women with the Allergan BIOCELL textured breast implants had an increased risk of developing a type of breast cancer known as anaplastic large cell lymphoma (BIA-ALCL).
According to FDA Principal Deputy Commissioner Amy Abernethy, “Once the evidence indicated that Allergan’s product appeared to be directly linked to significant patient harm…the FDA took action to alert the firm…that the recall is warranted.” Allergan voluntarily agreed to comply with the recall order from the FDA, stopping the sale of BIOCELL implants (both saline-filled, as well as silicone-filled) across the globe.
Allergan is now facing lawsuits from consumers who claim the corporation knew of the link between the breast implants and BIA-ALCL as early as the 1990s, however, continued selling and promoting the implants without warning the public of potential health risks.
Have the Allergan Breast Implants Been Recalled? Yes, certain Allergan breast implants have been recalled (complete list below). The implants were voluntarily recalled by Allergan—but only after the FDA published its report on the potential dangers of the Allergan breast implants. Allergan noted they were taking the action recommended by the FDA as a “precaution following notification of recently updated global safety information concerning the uncommon incidence of breast implant-associated BIA-ALCL…”
The BIOCELL saline-filled and silicone-filled textured breast implants and tissue expanders will no longer be distributed or sold in any market where they are currently available. The recall means that no new Allergan BIOCELL implants should be implanted, and that all current stock of these implants should be returned to Allergan. Allergan, a global pharmaceutical leader, is headquartered in Dublin, Ireland, marketing a wide variety of leading brands and products, primarily focused on “medical aesthetics, eye care, central nervous system and gastroenterology.” Allergan currently has commercial operations in 100 countries.
What are the Dangers of Allergan Breast Implants? According to the FDA, the textured surface—unique to Allergan breast implants—are tied to 481 cases of BIA-ALCL (Breast implant-associated anaplastic large cell lymphoma), which is a type of non-Hodgkin’s lymphoma. Across the globe, there have been 573 cases of BIA-ALCL, including 33 deaths. In thirteen of those cases, where a patient died—and the breast implant manufacturer was known—twelve involved an Allergan textured breast implant. BIA-ALCL attacks the immune system and is typically not diagnosed for years following the original implantation.
One plastic surgeon with the 740 Park Plastic Surgery in NYC, Daniel Maman, says it remains unclear why these particular textured implants could cause this type of cancer. Maman went on to say that the texture of the shell surrounding the implant could be causing the lymphoma response in the “capsule” tissues surrounding the implant. The FDA believes that, in most cases, the lymphoma cancer is limited to the fluids and scar tissue near the implant, but it can spread throughout the body. A diagnosis of BIA-ALCL is extremely serious and can lead to death, with some patients requiring chemotherapy and/or radiation. The FDA claims 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. About ten percent of all breast implants sold in the United States are textured.
What are the Different Types of Allergan Breast Implant Cancer? Textured breast implants cancer centers around anaplastic large cell lymphoma, also known as anaplastic large t-cell lymphoma and anaplastic t-cell lymphoma. BIA-ALCL lymphoma symptoms include excessive buildup of fluid around the breast implant. Further anaplastic large cell lymphoma symptoms are pain around the implant, swelling, lumps in the breast and lumps in the armpit. These symptoms of ALCL with breast implants typically occur between three to fourteen years following implant placement.
The FDA believes that women who are having no current symptoms of BIA-ALCL should not necessarily be alarmed, or rush to have the textured implant removed. The FDA also notes that while 28 of the 359 people who developed BIA-ALCL had smooth-surfaced implants, those women had textured surface implants or textured surface tissue expanders prior to the smooth-walled implants, likely contributing to the inflammation and subsequent development of BIA-ALCL.
Women who have experienced any BIA-ALCL lymphoma symptoms, should definitely see their doctor to determine whether they have developed Allergan breast implants cancer. Textured breast implants can lead to a diagnosis of Anaplastic large cell lymphoma, and if a woman receives this diagnosis, while treatment should be of paramount importance, it is also very important to speak to an experienced breast cancer lawyer as quickly as possible.
Typically, smooth-surface implants are more likely to be used for cosmetic breast surgery, while textured surface implants are more likely to be used during reconstructive procedures (but can also be used for cosmetic purposes). It is estimated that as many as 550,000 breast implant devices are currently implanted in women across the United States, however 13 percent or less of these devices are textured-surface breast implants.
How Can Breast Implant Lawyers Help? The Allergan breast implants, like other breast implants, may be associated with several serious health issues. While silicone fluid implants have been linked to leakage, polyurethane-covered implants have been linked to breast cancer. There are nine common injuries associated with breast plants in general, including: calcification, fibrous capsular contracture, infection, degradation, interference with mammograms, immune disorders, fetal injuries, an increased risk of breast cancer and other types of cancer, and immune disorders.
A breast implant could be deemed defective due to a manufacturing defect (a defect which occurred during assembly or production), a design defect (an error in the design of the implant, including materials used), or a warning defect (the company was aware of the issues surrounding the breast implant, yet failed to notify consumers and physicians). It appears the Allergan textured breast implant recall involves at least two of these issues—design problems and a failure to warn. If you have one of the Allergan textured breast implants listed below, you will want to speak to your physician and attend to your health, first and foremost. Next, you should consider speaking to experienced Sullo & Sullo breast implant lawyers.
Your breast implant lawyers may counsel you to consider a textured breast implant lawsuit. Entering into breast implant litigation can be a daunting step to take. We will answer all your questions regarding a breast implant cancer lawsuit, then help you determine whether an Allergan breast implant lawsuit is the right thing for you. There is currently at least one breast implant class action lawsuit, and it is expected that following the Allergan breast implant recall there will be considerably more breast implant litigation. Don’t face this issue on your own—speak to knowledgeable Sullo & Sullo breast implant lawyers as quickly as possible.
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)