Breast Implant ALCL Injury
Across America, women are seeking justice against breast implant manufacturers after experiencing injuries related to their breast implants.
In 2011, the FDA set forth its findings and analyses, reporting that the scientific community suggested an association between anaplastic large cell lymphoma (ALCL) and breast implants. The FDA stated “[a]lthough ALCL is extremely rare, the FDA believes that women with breast implants may have a very small but increased risk of developing this disease in the scar capsule adjacent to the implant.”
Approximately 1 out of every 26 women in the United States have breast implants.
About Breast Implants
For over 10 years, breast augmentation surgery is the most common cosmetic procedure in the United States. According to the American Society of Plastic Surgeons, in the United States, breast augmentation continues to be the top cosmetic surgical procedure and has topped the list since 2006. In 2016, surgeons performed nearly 300,000 breast augmentations, which is an increase of 37% from the year 2000.
Women decide to receive breast implants for a number of reasons. However, many women do not know that having implants increases their risk of developing ALCL.
Recent studies have shown that patients with textured implants face a higher risk of a rare form of cancer called breast implant-associated anaplastic large cell lymphoma (BIA ALCL). BIA ALCL is not breast cancer but also cancer of the immune system. The FDA reviewed literature and identified 688 cases of ALCL in women with breast implants. As of January 2011, the FDA was aware of 60 reports worldwide of ALCL in women with breast implants. FDA estimates the risk of BIA ALCL among patients with textured implants as between 1 in 3,817.
Anaplastic large cell lymphoma (ALCL) is a rare type of non-Hodgkin lymphoma (NHL), which is a type of cancer involving the cells of the immune system. ALCL is characterized by abnormal growth of T-lymphocytes (T-cells) and strong expression of a protein, cytokine receptor CD30. The two main types of ALCL include that which expresses the protein anaplastic lymphoma kinase (ALK-positive) and a second which does not (ALK-negative). Reports suggest an association between ALK-negative ALCL and silicone and saline-filled breast implants.
Breast Implants and ALCL
ALCL is a rare type of non-Hodgkin’s lymphoma and can appear in lymph nodes, skin, bones, soft tissue, lungs, or the liver. ALCL has an average latency of 8 years from breast implant to diagnosis. A medical professional finds ALCL cells in the fluid (seroma) surrounding the breast implant. A doctor can treat breast implant ALCL the type of T-cell lymphoma that develops around breast implants. ALCL is not a cancer of the breast tissue itself.
The World Health Organization (WHO) has recognized that breast implant-associated ALCL (BIA-ALCL) can develop following breast implant placement.
As of February 1, 2017, the FDA received a total of 359 medical device reports (MDRs) of BIA-ALCL. The FDA reported “There are 231 reports that included information on the implant surface. Of these, 203 were reported to be textured implants and 28 reported to be smooth implants. Most of the reports contained no information about the surface textures of any previous implants. In addition, 312 of the 359 reports included information on implant fill types. Of these, 186 reported implants filled with silicone gel and 126 reported implants filled with saline.”
On March 21, 2017, the FDA issued a statement, noting that the “FDA has updated its understanding of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) to reflect the agency’s concurrence with the World Health Organization designation of BIA-ALCL as a rare T-cell lymphoma that can develop following breast implants. At this time, most data suggest that BIA-ALCL occurs more frequently following implantation of breast implants with textured surfaces rather than those with smooth surfaces.”
The FDA has received 9 death reports.
ALCL & Natrelle Implants
French regulators upon investigating an Allergan plant discovered multiple offenses in the production process. According to the FDA approved salt-loss process, the implants after being soaked in warm water workers should be manually scrubbing the implants. Brushes will remove all solid particles to reveal a textured surface without damaging the surface. However, the regulators discovered that the manual scrubbing is not happening. Instead, workers are using irregular brushing at different degrees of cleaning. This allows seeping from the implants to cause chronic inflammation and stimulation of T-cell production and malignant transformation of those cells to ALCL.
Breast Implant ALCL Symptoms
When a woman has ALCL from her breast implant, she can experience the following symptoms:
- Swelling of the breasts
- Collection of fluid (seromas)
- Asymmetric breast size
- Hardening of the breast area
- Masses surrounding the breast area
Breast Implant ALCL Detection
The main diagnostic test is when a doctor asperates the seroma fluid. Then, it is sent for CD30-positive and ALK-negative t-cell lymphocyte testing.
Breast Implant Recall
Researchers from the National Cancer Institute found that ALCL occurs in an estimated 1 in 500,000 women each year, however, breast implant ALCL could happen in 1 in 3,000 women. Yet, many fear this number is underreported for several reasons, including the latency period of receiving the implant to the time a patient is diagnosed. Plus, physicians do not routinely do aspirations of seroma fluid when presented with women’s complaints.
On July 24, 2019, the FDA issued a recall of Allergan BIOCELL textured breast implants and tissue expanders since the agency acknowledged the cases of BIA-ALCL and BIA-ALCL-related deaths associated with these devices. There are almost 600 BIA-ALCL cases with 33 deaths. Of the cases, 573 had Allergan breast implants at the time of diagnosis. Those with Allergan BIOCELL textured implants have 6 times the risk of developing BIA-ALCL than other textured implants.
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)
Fear of Cancer
There are more than 3.8 million breast cancer survivors in the United States, including women still being treated and those who have completed treatment. Last year, there were 2 million more diagnosed. Millions of breast cancer survivors received these implants during their reconstruction surgeries. However, upon hearing that the implant could cause cancer, these women wanted them removed. Yet, insurance companies would not cover it again. Therefore, women had to pay tens of thousands of dollars to have them removed on their own.
This isn’t just women who are concerned they may not get cancer. These are women who have found the odds and beat breast cancer. Statistically, 1 in 6 people develops another type of cancer.
Therefore, if you had breast cancer and removed these implants proactively, you could receive compensation.
We Want to Help Breast Implant ALCL Victims
Furthermore, it is your right for manufacturers to inform you about the long-term risks associated with the medical devices, and it is the responsibility of manufacturers to provide this information. If a doctor diagnosed you with ALCL and you have breast implants, you should demand accountability. Why did the manufacturer not tell you?
Of course, we want to help send a message that this is not acceptable. We are advocates for consumers who have been harmed by dangerous products, and likewise, we have the experience necessary to successfully litigate these cases. In fact, Michael Brady Lynch, the founder of the Michael Brady Lynch Firm has spoken numerous times about this issue.
Contact the Michael Brady Lynch Firm today for a free consultation to learn more about seeking justice. Compensation may be available for any medical expenses associated with this ordeal, as well as for your physical and emotional suffering. There is no obligation.
How We Can Help
When you experience side effects from a dangerous drug, it can have devastating effects on your entire life. A verdict or settlement could also provide compensation for your injuries and damages. The types of recoverable losses are:
If a person dies from complications from a drug, family members may be able to recover damages for the wrongful death of their loved one, including:
- Funeral expenses
- Medical expenses prior to death
- Loss of economic support; and
- Loss of companionship
If the conduct of a company is found to be highly reckless, punitive damages may be awarded to punish the company and deter similar conduct in the future. If a doctor diagnosed you with ALCL after breast implants or you had them removed due to fear of getting cancer again, please speak to us to learn more about your rights.
The Michael Brady Lynch Firm is currently accepting cases in all 50 states. Please use the form on this page or call toll-free 24 hours a day at (888) 585-5970.