Allergan issued a voluntary recall of its Biocell Textured Breast Implants and Tissue Expanders following numerous reports of cancer linked to the use of certain implants and expanders. According to Allergan, the recall concerned the “uncommon incidence of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). The recall affects Biocell saline-filled and silicone-filled textured breast implants and tissue expanders, which will no longer be sold or distributed.
At Patterson Dahlberg, we have successfully represented clients who were harmed by medical device companies that were more concerned with profits than with safety. The risk of cancer is unacceptable in a breast enhancement or tissue expander device. Although the cancer is treatable if detected early enough, it can be life-threatening if not detected and still requires treatment.
Textured Breast Implant Recall
Allergan’s breast implant recall was announced in July after the US Food and Drug Administration (FDA) reported it was aware of an increased number of cases of breast-implant associated anaplastic large cell lymphoma. The cancer is incredibly rare but hundreds of thousands of patients have textured implants, and the risk associated with Allergan’s implants is six times higher than with other implants.
Breast-implant associated anaplastic large cell lymphoma typically arises 7 to 10 years after implantation surgery. Symptoms of the cancer include abnormal swelling—especially in one breast—pain, rash, itchiness, or changes in breast size, shape or firmness. These symptoms may indicate cancer or they could be a sign of a leaking implant. Patients who experience any of the symptoms should speak with a medical care professional.
When it issued its announcement about the recalled breast implants, the FDA noted that although the overall incidence of BIA-ALCL is currently relatively low, the agency took action because it appeared that one specific manufacturer was “directly linked to significant patient harm, including death.”
The FDA said it was aware of 573 cases worldwide of BIA-ALCL and 33 patient deaths, an increase of 116 new cases and 24 deaths over the agency’s previous update less than a year earlier. Of the cases, 481 have been linked to Allergan, while of the deaths, 12 of the 13 in which the implant manufacturer is known as Allergan. The FDA first became aware of a potential link between breast implants an breast implant-associated anaplastic large cell lymphoma in 2011.
BIA-ALCL is an immune system cancer, not a breast cancer even though it has been linked to breast implants. Patients who receive a diagnosis early enough can have their cancer cured by removing the implants and scar tissue surrounding the implant. Some patients may require chemotherapy and radiation. If the cancer is not detected quickly enough it can be fatal.
Recalled Breast Implants and Tissue Expanders
The recalled Allergan textured breast implants:
- Natrelle Saline-Filled breast implants: styles 163, 168, 363 and 468
- Natrelle Silicone-Filled breast implants: styles 110, 115, 120, TRL, TRLP, TRM, TRF, TRX, TCL, TCLP, TCM, TCF, TCX, TSL, TSLP, TSM, TSF and TSX
- Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Filled breast implants: styles 410FM, 410FF, 410MM, 410 MF, 410 FL, 410 ML, 410 LL, 410 LM, 410 LF, 410 FX, 410 MX, 410 LX
The recalled Allergan tissue expanders:
- Natrelle 133 Plus Tissue Expander
- Natrelle 133 Tissue Expander with Suture Tabs
Patients who are not sure about the manufacturer or model of the implants they received should speak with their surgeon or obtain medical records from the facility where the surgery was performed. Those who have the recalled implants are not advised to have them removed unless they show symptoms of cancer. Anyone who has concerns about leaving the implants in should speak with their doctor about their concerns and to determine a course of action.
Allergan Textured Breast Implants
The textured implants in question are designed with a rough shell that has a sandpaper-like surface. The purpose of the texture is to help the implant adhere to the soft tissue around it, keeping it in place and preventing distortion.
Textured breast implants are used less frequently in the US than around the world and Allergan’s macro-textured implants make up less than 5% of all breast implants used in the US. Canada, France, and Australia have all already taken action to recall or remove certain breast implants linked to BIA-ALCL.
Allergan Lawsuit News
Two Florida women have filed a $5 million lawsuit against the implant maker, alleging Allergan should pay for all surgical costs associated with removing the devices.
Join the Allergan Lawsuit
If you have received an Allergan breast implant and developed cancer as a result, you need a highly skilled personal injury attorney who has extensive experience advocating for patients harmed by the medical device industry.
At Patterson Dahlberg, we have decades of experience fighting against some of the biggest medical device manufacturers in the US to protect patients from harm caused by corporate greed. We believe it is critical to hold medical device makers like Allergan accountable for the dangerous products they put on the market.
Contact us today to speak with one of our attorneys about your situation. We are available to answer your questions and advise you of your rights. We will conduct a no-obligation review of your claim.