Breast augmentation is the most popular type of plastic surgery for women in the United States, with more than 300,000 operations performed each year. An additional 100,000 women undergo breast reconstruction each year following a mastectomy for breast cancer. While textured implants are only used in about 5% of these operations, women should be aware that Allergan textured breast implants have been linked to an increased risk of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL)—a rare type of non-Hodgkin's lymphoma.
Why Did the FDA Recall Allergan Breast Implants?
In July 2019, the Food and Drug Administration (FDA) asked the Irish pharmaceutical company Allergan to recall its textured breast implants due to the link between the devices and an increase in BIA-ALCL. More than two dozen counties, including Canada, France, and Australia, have already recalled the implants.
At the time the Allergan recall was announced, there were 573 cases of this type of rare cancer identified by the FDA, with 481 attributed to Allergan breast implants. Implant manufacturers could only be identified in 13 of the 33 confirmed deaths, but 12 of the women who died from BIA-ALCL had Allergan implants.
The link between textured breast implants and BIA-ALCL was first established in 2011. However, doctors have been unable to determine why this type of cancer is affected by the textured surface of the Allergan implants. It could be the body’s inflammatory reaction to the surface of the breast implant, which causes immune cells to become cancerous. Another hypothesis is that the immune system is overreacting to the bacterial “biofilm” coating the surface of the implant. Genetics are also suspected to play a role in determining who develops the condition.
What Is BIA-ALCL?
BIA-ALCL should not be confused with breast cancer. It is a rare type of non-Hodgkin’s lymphoma that affects the immune system and is most often found in the scar tissue or fluid near the implant. In some cases, BIA-ALCL can spread throughout the body.
Most cases of BIA-ALCL do not appear until several years after the implant surgery. Symptoms can include:
- Changes in breast size, firmness, or symmetry
- Persistent swelling of the breast
- Redness in the breast and surrounding area
- Pain near the implant
- Night sweats
- Swollen lymph nodes
BIA-ALCL is typically diagnosed with a physical exam, imaging tests, and examination of the fluid or tissue around the patient’s breast implants.
For most patients, treatment of BIA-ALCL involves surgery to remove the breast implant and the scar tissue surrounding the implant. Chemotherapy and/or radiation therapy may also be required, depending upon how far the disease has progressed. Early diagnosis of BIA-ALCL is associated with the best treatment outcomes.
What Types of Breast Implants Have Been Recalled?
Allergan BIOCELL textured breast implant products affected by the recall include:
- Natrelle Saline-Filled breast implants
- Natrelle Silicone-Filled breast implants
- Natrelle Inspira Silicone-Filled breast implants
- Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Filled breast implants
The recall also includes two types of tissue expanders used by patients prior to breast augmentation or reconstruction:
- Natrelle 133 Plus Tissue Expander
- Natrelle 133 Tissue Expander with Suture Tabs
Women with breast implants should have received a patient device card from their surgeon containing the device manufacturer, unique device identifier, and implant model name. If you do not have this information, you can request a copy of your surgery notes from the facility where the procedure was performed.
What Should Women Who’ve Received Allergan Breast Implants Do?
The FDA does not recommend women who have Allergan implants have them surgically removed if they are not experiencing symptoms linked to BIA-ALCL. The overall risk of developing BIA-ALCL is still low, and surgical removal of the implants carries its own risk. The safest approach is to remain alert for changes in the breast area and report any concerns to your doctor promptly.
If you have received textured breast implants from Allergan, Mentor, or another manufacturer and been diagnosed with BIA-ALCL, you should speak with an attorney who can advise you of your legal right to compensation. Women with BIA-ALCL can incur significant medical bills as well as lost wages and pain and suffering. Taking civil action holds the company accountable for the harm their implants have caused.
The dedicated legal team at Gray and White Law has extensive experience representing individuals who’ve been harmed by dangerous drugs or defective medical devices. We represent women in Kentucky, California, and across the United States who have been diagnosed with BIA-ALCL due to textured breast implants. We will advocate for you and your family to receive the maximum compensation allowed under the law. Call today to schedule a free, no-obligation consultation.