Certain breast implants manufactured by the pharmaceutical company Allergan have been recalled for posing health and safety risks. The implants were recalled, in part, due to their link to breast implant-associated anaplastic large-cell lymphoma, or BIA-ALCL. Women who have had breast implant surgery with any of the recalled implants may have medical and legal options available.
Allergan Recall Overview
Allergan has issued an international recall of both BIOCELL® textured breast implants and tissue expanders.
The recall was requested by the U.S. Food and Drug Administration (FDA) after the agency found that the implants have been linked to a form of cancer called breast implant-associated anaplastic large-cell lymphoma (BIA-ALCL).
Women who have had breast implant surgery with one of the recalled implants may have options available for both medical and legal help. Women impacted by the recall should contact a medical professional immediately for a physical evaluation.
Why Were Allergan Implants Recalled?
The FDA requested that Allergan recall its BIOCELL textured implants due to various health risks, including BIA-ALCL, a rare but serious form of cancer.
Symptoms of BIA-ALCL include:
- Breast hardening
- Changes in appearance of breasts
- Enlargement of breasts
- Lumps in the breast or armpit
- Redness or rashes on the skin
- Unusual weight loss
The FDA has estimated that “hundreds of thousands of women” have breast implants manufactured by Allergan. The FDA also found that there have been over 500 cases of BIA-ALCL globally that are related to breast implants. The agency noted that 33 patients have died from the condition.
Allergan followed through with the FDA’s recall request to minimize the number of women who were adversely affected by the breast implants.
The FDA has said they currently do not recommend the removal of the Allergan breast implants unless symptoms are present. That is why it is important to check with your doctor and get a full physical evaluation.
If you have any of the symptoms of BIA-ALCL, you may need to have your breast implants removed and begin medical treatment.
Allergan Implant Recall List
Not all of the breast implants manufactured by Allergan have been recalled. Some of the breast implants manufactured by Allergan are not associated with any cancer risk.
The specific Allergan implants recalled are:
- Natrelle Saline-Filled Breast Implants (Styles 163, 168, 363, 468)
- Natrelle Silicone-Filled Textured Breast Implants (Styles 110, 115, 120, TRL, TRLP, TRM, TRF, TRX, TCL, TCLP, TCM, TCF, TCX, TSL, TSLP, TSM, TSF, TSX)
- Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants (Styles 410FM, 410FF, 410MM, 410MF, 410FL, 410ML, 410LL, 410LM, 410LF, 410FX, 410MX, 410LX)
- Tissue Expanders (Natrelle 133 Plus Tissue Expander, Natrelle 133 Tissue Expander with Suture Tabs)
Those with one of the recalled breast implant products listed above may be at risk of developing BIA-ALCL. Always consult a medical professional to better understand your risk and determine if you have shown any symptoms.
The symptoms of BIA-ALCL often do not occur right away and can manifest years after your surgery has taken place. If any symptoms are present, it may be medically necessary to remove the breast implants.
What to Do If You Have Recalled Allergan Implants
The FDA pushed Allergan to recall their textured breast implants because of the serious risk of cancer, among other health problems.
The agency has also announced that it will consider adding a boxed warning label to Allergan’s breast implant products in the near future, which would detail the risk of cancer to both patients and physicians.
If you or a loved one have recalled Allergan breast implants, you have options. The first thing you should do is consult with your doctor. A medical professional can provide you with an objective medical evaluation and help you to determine if you are suffering from the symptoms of BIA-ALCL. ‘
If you have BIA-ALCL symptoms and need further medical treatment, you may be eligible for financial compensation to help cover medical and legal expenses.
Reach out to the team at Breast Implant Cancer Advocates to learn more about your options. We will answer all of your questions and help you determine the best course of action for your individual case.