Biocell Breast Implant Lawsuit

If you or someone you love have textured breast implants and experienced unusual side effects, you may be at risk of Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL). Read more to find out about recent breast implant recalls and why you should consider filing a breast implant lawsuit.

Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) is a serious but rare form of non-Hodgkins lymphoma. This kind of cancer affects the immune system and originates in the lymph nodes. It’s important to note, BIA-ALCL is not breast cancer.

BIA-ALCL can appear between the capsule and the implant, in the fluid surrounding the implant. The symptoms include swelling years after the surgery, of which a healthy implant should never swell. It’s imperative you speak with your plastic surgeon or healthcare provider if you experience any unusual symptoms of breast swelling.

National Comprehensive Cancer Network is recognized for its sound research by the Food and Drug Administration, as well as a handful of other research cancer societies. In a recent study, the most common demonstration of BIA-ALCL was built-up fluid around the breast implant (also known as a large spontaneous periprosthetic fluid).

In the report issued by the NCCN, the symptoms occurred anywhere from one, to an average of seven to ten years following cosmetic or reconstructive implantation.

The FDA has issued safety warnings about the unusual cancer that’s popping up both in the United States, and around the globe. As of July 6, 2019, the FDA received 573 medical device reports (MDR) of BIA-ALCL worldwide. Of that total, there have been 33 deaths. 

Additionally, 481 out of 573 reports indicated they had Allergan breast implants at the time of their diagnosis – and 12 out of 13 deaths (where the manufacturer was known) included Allergan breast implants. The other 20 deaths did not indicate who the manufacturer was.

“In most cases, BIA-ALCL is found in the scar tissue and fluid near the implant, but in some cases, it can spread throughout the body,” the FDA announcement said.

Cases reported in the United States showed no difference in likelihood for BIA-ALCL to occur for those with reconstructive surgery or those who had cosmetic breast enhancement. Of those diagnosed with BIA-ALCL, 56% had them implanted for cosmetic purposed, and 44% had them implanted for reconstructive purposes.

FDA Biocell Breast Implant Update

Health Canada initially issued a recall in May 2019 of Allergan textured breast implants from the Canadian market due to the high incidence of lymphoma. The specific textured implant was once again reported in a high incidence of BIA-ALCL diagnoses.

The Health Canada statement read: “..because the potential risks associated with the implants outweigh their benefits, including the rare but serious risk of BIA-ALCL, Health Canada has suspended the licenses for Allergan’s Biocell breast implants (the only macro-textured implants available in Canada).”

In 2019, at the request of the FDA, the major breast implant manufacturer recalled its entire line of textured breast implants and tissue expanders from the US and worldwide markets. In a press release from July, Allergan announced its textured implants and tissue expanders would no longer be distributed or sold in any market where they’re currently available.

Additionally, healthcare providers should no longer be performing cosmetic or reconstructive surgery with the Biocell saline-filled and silicone-filled textured implants and tissue expanders.

“..at the present time, we believe all individuals who are considering a breast implant of any type be informed of the risk of developing BIA-ALCL.” 

-FDA update, 07/25/19

Post-BIA-ALCL Diagnosis

Textured breast implants only account for roughly 10% of implants in the United States. However, the numbers indicate there is a high risk of developing BIA-ALCL. 

One of the tests for BIA-ALCL is checking for a fluid collected around the breast implant called CD30. It is a type of protein in cell membranes that abnormally shows up in cases of the lymphoma. If the patient tests positive for CD30, they will need to undergo surgery to remove the ‘capsule’ (or scar tissue) around the implant, as well as the implant itself.

According to the FDA, this is a more extensive and time-consuming operation than a standard implant removal.

As with any cancer or serious ailment, the earlier the better when it comes to treating BIA-ALCL – but this also means coming up with the funds for surgery. Many people have to contend with their insurance companies to cover breast implant removal surgery, even when they are diagnosed with BIA-ALCL.

According to the American Society of Plastic Surgeons, the average out-of-pocket cost of breast removal is $2,566. This does not include anesthesia, operating room facilities, x-rays and medical tests, prescriptions for medication, and other expenses.

When filing a breast implant lawsuit, your attorney will take this into consideration for holding the manufacturer accountable for your BIA-ALCL diagnosis.

The following is a list of the Allergan breast implants and tissue expanders that have been recalled from the market.

Allergan Natrelle Saline-Filled Breast Implants (formerly McGhan RTV Saline-Filled Mammary Implant). Approved under P990074.

• 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)

Filing a Biocell Breast Implant Lawsuit

Any adverse health conditions or complications can be incredibly nerve-wracking. It’s important you find a lawyer who is skilled in compassion for your situation. When filing a Biocell breast implant lawsuit, your attorney will not only hold the manufacturer accountable for a defective and dangerous product– they will look for ways to win financial compensation for the emotional labor behind a BIA-ALCL diagnosis. This includes time spent away from work and family before, during, and after surgery, medical costs incurred, etc.