The U.S. Food and Drug Administration identified a possible association between breast implants and a type of rare cancer called anaplastic large cell lymphoma in 2011. Since then, scientists have conducted studies and analyzed data trying to determine the issue. While the cause is not yet identified, research shows that women who receive breast implants have an increased risk of developing a particular type of cancer called breast-implant associated anaplastic large cell lymphoma – BIA-ALCL.
This cancer strikes the immune system, not the breast, so even though the cancer is found in breast tissue, it is not breast cancer. Though scientists have not yet determined how the implants are causing this lymphoma, they believe it could be from bacterial contamination, genetics, or an inflammatory response. It’s important to understand that even though most cases involve women, there have been three reported cases of BIA-ALCL in transgender (male to female) patients.
How Many People Get BIA-ALCL
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For as long as women have gotten breast implants, it wasn’t until 2011 that the FDA reported on BIA-ALCL after becoming aware of about 60 cases of this cancer around the world. However, by 2017 the FDA had received reports of at least 414 cases of BIA-ALCL including nine deaths. Not all of the reports included specific information about the implant. Of those that did, 30 were smooth, and 242 were textured, and 179 were filled with saline and 234 were silicone gel.
A study published in the medical journal JAMA Oncology in March 2018 suggested that patients who are diagnosed with ALCL were over 421-times more likely to have breast implants than women who were diagnosed with other types of breast lymphoma. Researchers identified the absolute risk of developing BIA-ALCL. According to their data, about one person for every 6,920 who get breast implants will develop BIA-ALCL before age 75.
Symptoms of BIA-ALCL
Any person who receives breast implants should be aware of the symptoms of BIA-ALCL. According to the FDA, if you have breast implants, you should see your doctor if you notice:
- persistent fluid build-up (seroma) around the implant
- the area around the implant feels hard and firm
- any lumps or masses around the implant
- swelling
- pain
- lopsided breasts
Patients who are diagnosed with BIA-ALCL are urged to learn more about their rights and to contact us now to see if they are eligible to seek compensation for their injuries.
Investigations Continue
At least nine deaths in the U.S. have been attributed to BIA-ALCL spurring scientists and regulatory agencies to further investigate BIA-ALCL and determine more thorough cause and outcome data. At least 46 cases and three deaths in Australia have been associated with BIA-ALCL, and officials in France ordered textured breast implant manufacturers to analyze and determine the reaction of live tissue to the implants and report their findings to the National Agency for Medicines and Health Products Safety. The Plastic Surgery Foundation and The National Comprehensive Cancer Network are working to develop data to help physicians understand the disease and improve diagnosis and treatments.
Treatment for BIA-ALCL
If you have breast implants, you should perform self-examinations regularly, paying particular attention to the areas around the implant. If you notice changes in the shape of the breast, or if you feel pain or notice lumps, swelling, fluid buildup, or hardness, speak with your physician as soon as you can. The FDA also recommends that you speak to your doctors about ensuring your images are screened by a technician who has special training in reading the mammograms of patients with implants. If you have silicone gel implants, you should have an MRI performed every two years. This test can help doctors identify possible ruptures in the implant membrane.
The majority of BIA-ALCL patients who are diagnosed early are treated through surgical removal of the implants. However, if the cancer cells have invaded local tissue or spread to somewhere else in the body, patients may need to have chemotherapy and radiation treatments.
Be aware: BIA-ALCL typically presents years after implantation so it is very important that patients who have implants monitor their breasts regularly with self-checks and medical exams so that this lymphoma can be diagnosed and treated early.
How We Can Help
As investigations into BIA-ALCL continue, patients who developed this cancer are questioning why BIA-ALCL was not investigated before the devices were sold on the market. Patients who developed the lymphoma and the families of those who died from the disease are filing lawsuits against the makers of these breast implants demanding to know when the makers knew or should have known their products increased the risks of BIA-ALCL.
Patients also want to know why warnings about the increased risks of BIA-ALCL weren’t provided early and why the warnings aren’t stronger. They are questioning why potential live tissue reactions were not investigated and why the products were not recalled from the market after the increased risk of BIA-ALCL was discovered.
If you or a breast implant recipient you love was diagnosed with BIA-ALCL is it important to know that you have rights and for decades we have fought to protect the rights of patients harmed by medical products that are supposed to be safe. We stand ready to fight for you now. Contact us to learn more about patient rights, defective products, and whether you are eligible to seek financial compensation for your BIA-ALCL.
Key Concepts You Should Know
If you have smooth or textured saline or silicone gel breast implants, you have an increased risk of developing a type of lymphoma that starts in the breast but isn’t breast cancer. It’s called breast implant-associated anaplastic large cell lymphoma or BIA-ALCL. If you have implants, there are some key facts you need to be aware of.
Is BIA-ALCL the Same as Breast Cancer?
No, even though the cancer starts in the breast, it is actually a cancer of the immune system. Scientists are studying the connection between implants and this type of lymphoma and believe it could be caused by an inflammatory response, genetic predisposition, or bacterial contamination. In short, they just haven’t figured it out yet. However, research continues, and cases are being monitored. Interestingly, some geographic areas report more cases than others. But data is being collected across the globe to help scientists determine the possible root cause.
How Serious is the Problem?
It’s important to understand that BIA-ALCL affects both women and transgender men who have breast implants though researchers do not know how many people have been affected. According to the food and Drug Administration, at least 414 cases had been reported by 2017. Research is showing that for every 6,920 people who get implants, at least one person will develop BIA-ALCL during their lifetime.
Symptoms You Should Know
If you have implants, you should perform a self-breast exam regularly. Some check them every time they take a shower. Look and feel for hardness, lumps, fluid or swelling. As you check, take note of any pain you may experience. Look at your breasts in the mirror to see if they are becoming uneven or lopsided. If you notice any issues, talk to your doctor as soon as possible. Breast implant recipients need to be aware that the symptoms of BIA-ALCL may not appear for years after implantation.
Do You Have a Lawsuit?
If you have breast implants and were diagnosed with BIA-ALCL, you may be entitled to seek compensation from the manufacturer. People who have already filed lawsuits seeking compensation for their injuries are accusing the manufacturer of failing to warn of the increased risks of a particular type of cancer. They want to know why the manufacturers did not conduct live tissue studies, and why the makers didn’t pull the implants from the market once the association between breast implants and cancer was discovered.
Understanding Damages
When patients are implanted with medical devices that cause injury, they may incur medical costs and expenses related to the injury. They may have to miss work and wages, and they may suffer pain, disfigurement, and permanent scarring. Though the cancer is usually treated with implant removal, some patients may have to undergo chemotherapy and radiation treatments and incur additional medical costs and missed wages.
The law allows patients harmed by a medical device to seek damages or compensation for their injuries and losses. These damages may be determined by the amount of costs and expenses incurred, and the amount of wages of you lost by missing work. A monetary amount is often determined for non-tangible injuries such as pain and suffering. These damages are awarded to make the patient financially whole again, such as by compensating them for the money they have lost and the pain they have endured.
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