Allergan Breast Implant Recall
Allergan BIOCELL textured breast implants and tissue expanders have officially been recalled due to the increased risk of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). The FDA recall request was based on new Medical Device Reports (MDRs) showing a six fold increase in the risk of developing BIA-ALCL. Allergan, headquartered in Dublin, Ireland, has voluntarily agreed and is conducting a global recall of the defective breast implants.
The recall is specific to textured implants as opposed to smooth. Dr. Daniel Y. Maman, a New York plastic surgeon, stated in an NPR article that the surface of the textured implant can interact with surrounding scar tissue which prompts an immune response in the body. "It is this response that is responsible for the formation of the lymphoma."
According to the FDA, there have been approximately 573 reported cases of BIA-ALCL worldwide and 33 patient deaths. Of those 573 cases, 481 were reported to be manufactured by Allergan. Seven months before the FDA's recall, Allergan textured breast implants were recalled in Europe after only 6 cases of BIA-ALCL had been diagnosed. Four month's later, Canada followed suit and issued its own recall.
Based on the information currently available the FDA has released statistics which show that "the risk of BIA-ALCL with Allergan BIOCELL textured implants is approximately 6 times the risk of BIA-ALCL with textured implants from other manufacturers marketing in the U.S. and continued distribution of Allergan's Biocell BIOCELL textured breast implants would likely cause serious, adverse health consequences and potentially death from BIA-ALCL."
In spite of these statistics, the FDA is not presently recommending that women have the implant removed. Rather, it suggests that they monitor themselves for signs and symptoms of BIA-ALCL, and if they notice any, consult with their doctor. While this advice might make sense from a statistical standpoint, it is of little comfort to women who must live with the knowledge that they have a medical device in their body that is significantly increasing their risk of developing cancer.
List of Recalled Products
- some styles of Allergan Natrelle Saline-Filled Breast Implants (formerly McGhan RTV Saline-Filled Mammary Implant)
- some styles of Allergan Natrelle Silicone-Filled Textured Breast Implants (formerly Inamed Silicone-Filled Breast Implants)
- some styles of Natrelle 410 Highly Cohesive Anatomically Shaped Silicone Filled Breast Implants
- Natrelle 133 Plus Tissue Expander (K143354)
- Natrelle 133 Tissue Expander with Suture Tabs (K102806)
A complete list of recalled products can be found in the FDA's recall announcement.
About Breast Implant-Associated Anaplastic Large Cell Lymphoma
The cancer associated with textured breast implants, BIA-ALCL, is a form of non-Hodgkin's lymphoma. A common misconception is that the implants are linked to breast cancer, however they are not. BIA-ALCL is a type of immune cancer, which has a high survival rate and is often very treatable when caught early. BIA-ALCL usually forms around the scar tissue or fluid surrounding the implant, but does have potential risk to develop or spread elsewhere.
Symptoms and Warning Signs
Often times, the symptoms of BIA-ALCL present as other common postoperative complications such as mastitis, infection or shingles and can easily be misdiagnosed. Some symptoms to be aware of include but are not limited to the following-
- Swelling around lymph nodes in neck, armpit or groin
- Excessive swelling in the breasts, causing pain and redness
- Lumps in the breast or armpit
What Action Can You Take?
The lawyers at Sullivan & Brill, LLP are currently representing women that have been implanted with these recalled breast implants and are investigating the strength of their legal claims. A medical device manufacturer has a duty to ensure that the device is reasonably safe for its intended purpose and to warn consumers of the risks of which it is aware. If the medical device is not suited for its intended purpose or if the manufacture is aware of risks, but does not warn of these risks, the company can be held responsible for the harm the device causes. This can include medical costs associated with the removal of the device, the mental and emotional suffering caused by living with the defective device, any loss of earnings occasioned by a revision surgery or post-surgical complications and the pain and suffered associated with the removal of the defective device and any damage or complications that occur during a revision surgery.
For a free consultation on whether you have a viable claim, call 212-566-1000 or complete the form on the right and one of our attorneys will contact you.