UPDATE: July 24, 2019 – Allergan announced it will recall its BIOCELL textured breast implants due to their association with about six times the risk of developing breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) compared to other textured implants. The announcement comes after the FDA requested they issue the recall, noting that 481 out of 573 reported BIA-ALCL cases involved Allergan implants, and that 12 out of 13 deaths in patients with known implant manufacturers involved Allergan implants. BIA-ALCL is a deadly form of non-Hodgkin’s lymphoma and the FDA notes a total of 33 patient deaths associated with the cancer.
The Breast Implant Lawsuit Attorneys of Nadrich & Cohen, LLP respond to the recent 2017 FDA Alert regarding the lymphoma risk associated with certain types of breast implants. This is not the first FDA warning regarding this risk. The Lawyers of Nadrich & Cohen, LLP are currently investigating Dangerous Breast Implant claims for victims in California and throughout North America.
2011 FDA Anaplastic Large Cell Lymphoma Alert
In 2011, the Food and Drug Administration (FDA) become aware of a link between anaplastic large cell lymphoma and breast implants. However, at that time, there were so few cases that it was impossible to find out what caused the link.
Since then, the FDA has done extensive research to learn more about the link. Medical literature, product and labeling information, data from patient registries and medical device reports assisted the FDA with this process.
As of February 2017, the FDA had compiled 359 medical device reports. Nine reports detailed deaths caused by anaplastic large cell lymphoma. More than 200 reports were associated with implants that had textured surfaces. In addition, 312 reports had information about the material type. Of those, 1126 had saline and 186 had silicone gel.
From these reports, the agency recently learned that anaplastic large cell lymphoma is a rare T-cell lymphoma that women can develop after having breast implant surgery. In addition, those with textured surfaces are more likely to cause lymphoma.
The FDA has also been made aware of cases of anaplastic large cell lymphoma outside of the United States. There have been 46 cases in Australia, along with three deaths. All of the cases involved textured implants.
In France, manufacturers of textured implants have been tasked with determining how textured implants react to living tissues. They have one year to report their findings.
I Have Breast Implants, Am I At Risk For Developing Anaplastic Large Cell Lymphoma?
While the most recent FDA alert is concerning to breast implant patients, the risk of developing Anaplastic Large Cell Lymphoma is very low.
The medical community is not presently recommending that women have their breast implants removed based on this warning. Instead, physicians are advising breast implant patients to regularly visit their doctor for preventative care and monitoring.
What Are The Symptoms of Anaplastic Large Cell Lymphoma?
Patients should be aware of signs of anaplastic large cell lymphoma. These include swelling, lumps, asymmetry and pain. They should be aware of any changes in shape and texture and have mammograms done regularly.
What Are The Available Treatments for Anaplastic Large Cell Lymphoma?
Patients who are diagnosed with anaplastic large cell lymphoma may be able to have their cancer treated by removing the implants and capsule surrounding the implants. Radiation and chemotherapy are also possible forms of treatment.
How Do I Find Out If I Have A Claim?
If you or a loved one had a breast implant procedure and were subsequently diagnosed with Anaplastic Large Cell Lymphoma, immediately contact our office for a free consultation. Our Breast Implant Lawsuit Attorneys have successfully handled many defective product claims against some of the world’s largest medical device manufacturers and pharmaceutical companies.