Certain breast implants, primarily the Biocell textured breast implants, and tissue expanders, manufactured by Allergan, have been recalled as of July 2019 for posing health and safety risks.
The implants are linked to breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), a non-Hodgkin’s lymphoma.
Allergan Breast Implant Recall
In July 2019, due to a rise in cases of BIA-ALCL, the U.S. Food and Drug Administration (FDA) requested the maker of the textured breast implant to recall them in the U.
S. market. After the FDA’s request, Allergan initiated a voluntary recall in 38 countries globally due to the possible link between breast implants and lymphoma. When the FDA requested the recall, the agency confirmed reports of 573 cases of BIA-ALCL worldwide, with 33 resulting in death. Of the 573 cases, 481 were linked to Allergan implants.
Although the FDA acknowledged a link between BIA-ALCL and textured implants in 2011, there was no recall since there were only 34 cases of BIA-ALCL from 1997 to 2010 worldwide. It was determined that there were too few cases to act. The FDA decided to make public and share the information on textured implants, stating in their 2011 FDA Update on the Safety of Silicone Gel-Filled Breast Implants that “Women with breast implants may be more likely to be diagnosed with anaplastic large cell lymphoma (BIA-ALCL).”
In May 2020, after the FDA recall, the FDA issued a warning to the manufacturer regarding its failure to complete post-market safety studies. When the FDA approved the breast implants, there was a stipulation for the manufacturer to collect data from patients for a safety study, which they failed to do.
What is BIA-ALCL?
Breast Implant-Associated Lymphoma (BIA_ALCL) is a rare form of cancer caused by textured implants. It is not breast cancer, instead, it is a type of non-Hodgkin’s lymphoma which means it is a type of immune system cancer. It occurs in the fluid and scar tissue around the implant, and in some advanced cases, it may spread to other parts of the body. BIA-ALCL tends to grow slowly; healthcare providers usually treat it surgically by removing the breast implant and surrounding capsule. In rare cases, it can be fatal.
The most common symptoms of BIA-ALCL are swelling, changes in the size or shape of your breasts, and pain in the breast implant. These symptoms can appear as early as one year after you receive the implant or many years later. On average, symptoms start eight years after implant surgery. Symptoms of BIA-ALCL include:
- Hardening of your breasts
- Enlargement or swelling of the breasts
- Lumps in your breast or armpit
- Redness or skin rash on or around the breast area (rare symptom)
Only Certain Batches of Implants Were Affected
Not all the breast implants manufactured by Allergan have been recalled. Some of the breast implants manufactured by Allergan are not associated with any cancer risk. According to the U.S. FDA, 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 risk developing BIA-ALCL. If symptoms are present, always consult a medical professional.
The symptoms of BIA-ALCL do not always occur immediately and may not happen for years after the implant surgery. If any symptoms are present, removing the breast implants may be medically necessary.
What to Do If Your Implants Are on the List
According to the U.S. FDA, if you have Allergan recalled breast implants, they do not need to be removed if you do not have symptoms of BIA-ALCL or other issues. However, you should discuss the issue with your health care provider, particularly if you experienced any issues with your implants.
If you have Allergan BIOCELL implants, you should understand that textured surface implants are associated with a low, but real risk of BIA-ALCL, a cancer of the lymphatic system. You should know the signs and symptoms of the disease. If you have your breast implant(s), you should monitor your breast area for any changes.
Contact an Attorney for Legal Guidance Following a Breast Implant Recall
Suits against Allergan are growing, with cases being coordinated in both New Jersey State Court and New Jersey Federal Court. If you or a loved one suffered an injury from textured breast implants, including a diagnosis of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) after implant surgery, contact our medical device attorneys for a free case evaluation.
At Charles Boyk Law, we have expertise with representing patients in medical devices litigation and have medical specialists on staff to assist in reviewing these complex cases. We aim to ensure you get the best legal team possible and recover maximum compensation for your pain and suffering and the expenses you have suffered due to your defective implant. Contact our office today so we can review the circumstances of your case, answer your questions, and review all available options.