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.
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.
In September 2011, the FDA decided against issuing a breast implant recall. The government agency is asking the main breast implant manufacturers for more studies. Allergan and Mentor, a Johnson & Johnson subsidiary, control half of the breast implant market. Breast implants are almost 10% of Allergan’s $4.5 billion yearly earnings. If the studies show anything significant, the FDA could change breast implant labeling requirements.
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.
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, 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 877-513-9517.