A recent recall requested by the FDA has put the spotlight on Allergen breast implants—specifically, their Biocell line of implants—and those unfortunate enough to have these implants. The recall announcement, released in July of 2019, states that those with Biocell implants face a disturbingly high risk of developing cancer due to the implants.
If you or someone you know has Biocell implants, you should be aware of the risks those implants may pose. You should also be aware of your legal options if your implants cause you to develop breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), or anaplastic large cell lymphoma (ALCL) as it is commonly referred to.
Rosenfeld Injury Lawyers LLC is actively investigating and prosecuting Allergen breast implant cases and stands ready to assist you and your family. As with all of our medical device cases, we work on a contingency fee basis where there is only a fee charged when we are successful on your behalf
Which Allergen Breast Implants Were Recalled?
The implants that the FDA requested that Allergen recall used a technology branded as Biocell. The Biocell implants featured a fine texture that helped them stay in place inside the body. The way the roughened surface of the implant interacted with the tissues in the breasts caused the implants to remain relatively stable and not move around in the body, as some other breast implants with smoother surfaces have been known to do.
Allergen’s Biocell implants are not the only type of textured breast implants—in fact, there are many implants featuring textured surfaces. Unfortunately, something about the way that the textured surface of Biocell implants interacted with body tissue led to a significantly higher rate of cancer development than with other textured breast implants.
What Type of Cancer do Biocell Implants Cause?
According to the FDA, “BIA-ALCL is not breast cancer - it is a type of non-Hodgkin’s lymphoma (cancer of the immune system). In most cases, BIA-ALCL is found in the scar tissue and fluid near the implant, but in some cases, it can spread throughout the body.”
However, just because the cancer is not the breast cancer most people are familiar with does not mean it is no cause for concern. A diagnosis of ALCA can lead to death in certain situations, such as if the cancer is not diagnosed early enough or the individual with cancer does not get appropriate treatment.
The treatment for ALCA in most patients involves surgery. The surgeon removes the implant as well as the scar tissue that surrounds the implant. It is important that the surgeon gets all the tissue that has developed tumors or other cancerous tissue, which means that the surgery can be quite invasive and hard on the patient.
What Reasons did the FDA Give for the Recall Request?
According to the FDA, “The FDA’s analysis was attributed to a new worldwide reported total of 573 unique BIA-ALCL cases including 33 patient deaths. Of the 573 cases of BIA-ALCL, 481 are reported to have Allergan breast implants at the time of diagnosis. In addition, 12 of 13 deaths occurring in patients with BIA-ALCL where the manufacturer was known occurred in patients implanted with an Allergan breast implant at the time of their BIA-ALCL diagnosis.”
As mentioned above, there are many other breast implants that feature a textured surface to help the implant remain in place. However, according to the FDA, “Based on the currently available information, including the newly submitted data, our analysis demonstrates 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.”
Did the FDA Wait too Long?
Concern about the Allergen Biocell implants has been building for some time—in fact, it can be argued that it peaked some time back and the FDA has gotten to the issue quite late. There were reports noting that Allergan textured breast implants were unsafe back in March of 2017. The implants the FDA are focusing on were removed from the market in 38 other countries before the FDA issued a recall request. With so many other countries deciding that the implants are unsafe, it is unfortunate that the FDA took so much time to make its decision on the dangers of the Biocell products.
What Should You do if You Have Allergen Biocell Implants?
What you should do if you have Allergen Biocell implants depends on your individual circumstances. The FDA recommends:
- Those without symptoms should not have the implants removed at this time. There are a number of different Allergen products included in the recall, but the overall risk of developing ALCL is low even with recalled products. That is why it is generally safer to keep breast implants—all breast implants—rather than go through surgery to have them removed if you have no symptoms and your doctor is not recommending their removal.
- Be aware of the symptoms of ALCL. If you experience any of the symptoms you should speak to your health care provider. You will likely need to go through an exam and other diagnostic tests to verify if you have ALCL.
- If you have ALCL caused by the Allergen Biocell implant, your health care provider will likely recommend that you have the implants removed as well as the scar capsule surrounding the implant.
What are Your Options for Taking Legal Action?
There are several reasons to consider taking legal action against Allergen if their implants caused you to develop ALCL. One of the most obvious benefits is that if your lawsuit is successful you can get compensation for your injuries, which you can use to pay for medical treatments and take care of you and your loved ones during and after recovery. However, legal action can also serve another purpose—to hold Allergen accountable for their actions. Although the company’s products were removed from the market in 38 countries, Allergen did not choose to remove its Biocell implants from the U.S. market until the FDA asked them to.
If you or a loved one has been diagnosed with ALCL caused by Allergen brand breast implants, we encourage you to contact our firm to discuss your legal options.
Breast Implant Cancer Resources
- The FDA Requests Allergan Voluntarily Recall Natrelle BIOCELL Textured Breast Implants and Tissue Expanders from the Market to Protect Patients: FDA Safety Communication
- Allergan Issues Worldwide Recall of Biocell Textured Breast Implants and Tissue Expanders
- Questions and Answers about Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL)