A U.S. Food & Drug Administration (FDA)-prompted Class 1 recall one year ago led an Ireland-based company to stop manufacturing and marketing its cancer-causing, textured breast implants and tissue expanders. The recall, the most serious type issued by the agency, followed an FDA analysis that concluded the implants made by Allergan increase the risk of a patient contracting a rare disease called breast implant associated anaplastic large cell lymphoma (BIA-ALCL).
“Based on the currently available information, the FDA’s analysis demonstrated 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 textured breast implants would likely cause serious, adverse health consequences, including death, from BIA-ALCL,” states a Sept. 12, 2019, notice on the FDA’s Web site titled “Allergan Recalls Natrelle Biocell Textured Breast Implants Due to Risk of BIA-ALCL Cancer.”
“Of the 573 worldwide reported total cases of BIA-ALCL, 481 patients are reported to have Allergan breast implants at the time of diagnosis. Of those cases, 12 deaths occurred in patients implanted with an Allergan breast implant at the time of their BIA-ALCL diagnosis.” In all, 33 patients have died from BIA-ALCL; the manufacturer / manufacturers of the textured implants that caused the other 21 deaths is / are unknown. And now there are 900-plus incidents of BIA-ALCL that have been documented.
“The FDA will continue to evaluate any new information and may, as a result, take action regarding other breast implants, if warranted,” the agency states a safety communication titled “The FDA Requests Allergan Voluntarily Recall Natrelle BIOCELL Textured Breast Implants and Tissue Expanders from the Market to Protect Patients: FDA Safety Communication.” “Although most cases of BIA-ALCL are associated with the use of textured breast implants, particularly macro-textured implants – such as those made by Allergan, we are continuing our assessment to determine whether the risk of developing BIA-ALCL is limited to specific models of textured, or all textured breast implants. Therefore, at the present time, we believe all individuals who are considering a breast implant of any type be informed of the risk of developing BIA-ALCL.”
What Is BIA-ALCL?
BIA-ALCL is not breast cancer. Instead, it is a form of lymphoma – specifically nonHodgkin’s lymphoma – an immune system cancer. The FDA explains in the safety communication that the rare disease has a low development rate but is extremely dangerous if and when it is contracted.
“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,” according to the FDA. “At this time, the overall incidence of developing BIA-ALCL is considered to be low; however, a BIA-ALCL diagnosis is serious and can lead to death, especially if not diagnosed early or promptly treated. In most patients, BIA-ALCL is treated successfully with surgery to remove the implant and the scar tissue surrounding the implant; however, some patients may require treatment with chemotherapy and / or radiation therapy.”
What Are the Symptoms?
The symptoms most commonly associated with BIA-ALCL are breast pain and swelling, the accumulation of excess fluid near the implant, skin rashes and a lump or a mass surrounding the implant. The American Board of Cosmetic Surgery published a blog addressing the potentially life-threatening issue. “Here at the American Board of Cosmetic Surgery, our primary objective is patient safety,” states the blog, titled “An Update on BIA-ALCL: What Patients Should Know About Allergan’s Recall of Textured Breast Implants.” “To that end, we’ve answered many common questions about Allergan’s recall and provided our recommendations for patients based on the currently known facts.”
The plastic surgery medical organization further advised breast implant patients – “Currently, we are not advising patients with textured breast implants who are not experiencing symptoms to have their breast implants removed prophylactically,” the blog continues. “The FDA seconds this recommendation, largely because the risk of developing BIA-ALCL is very small. Additionally, an unnecessary breast implant removal procedure can potentially be traumatic to your body and may leave you feeling unhappy with the appearance of your breasts. For these reasons, if you are happy with your augmented breasts and have not noticed any unusual symptoms or experienced any discomfort, it is advisable to keep your implants.”
It is important for patients who are experiencing symptoms to see their doctors – as these same symptoms (breast pain, swelling, and the presence of fluid or a mass around the implant) could also be signs of a silent rupture of the breast implant, capsular contracture of the scar tissue around the implant, or a breast infection and would require a different course of treatment.
The American Board of Cosmetic Surgery noted – “Your physician will begin by performing a physical examination, potentially followed by an ultrasound or MRI to determine if there is any fluid build-up or lumps around the breast implant or in the lymph nodes,” according to the blog. “If fluid or a mass has been discovered, a needle biopsy will be ordered to test for CD30 immune staining to rule in or out BIA-ALCL. If pathology comes back positive, complete surgical excision of the breast implant and the surrounding capsule of scar tissue will be performed by a surgical team that includes your cosmetic surgeon, oncologists, and pathologists, per BIA-ALCL treatment recommendations from the National Comprehensive Cancer Network (NCCN).”
Allergan Cancer Lawsuits
Lawsuits stemming from the defective Allergan BIOCELL textured devices are moving forward, with the consolidation of what is expected to be more than 100 cases in multicounty litigation (MCL) in New Jersey Superior Court and multidistrict litigation (MDL No. 2921) in federal court. This litigation effort is separate from the tens of thousands of coordinated breast implant lawsuits that were filed in the early 1990s against various manufacturers of gel-filled and saline breast implants including Bristol Myers, Dow Corning, 3M, McGhan Medical, Mentor, and Baxter Healthcare. Those lawsuits were litigated as individual and class action lawsuits through an MDL in Birmingham, Alabama and through various coordinated state court venues years ago. The original breast implant lawsuits were focused primarily on claims that the implants ruptured and caused various autoimmune diseases, although there were a small number of lawsuits litigated more than 20 years ago involving patients who developed immune-mediated cancers, such as multiple myeloma, that were believed to be caused by the silicone present in the implants.
Discovery efforts are current underway in the Allergan state and federal court breast implant cancer litigation, and the judges overseeing the cases are expected to focus in the future on pretrial motions and preparation for the first “bellwether” trials in the coordinated proceedings.
Is Allergen Negligent?
On May 14, the FDA wrote Allergan a warning letter, blasting the company for its failure to comply with the requirement of conducting a study that would have assessed the long-term risks of its recalled implants. Allergen basically blew off the patient-follow-up step. A few days after the letter went public, Fortune Magazine posted an excoriating expose titled “‘They killed her’: Why are breast implants still putting millions of women at risk?”
“More than 903 women have now been diagnosed with that once-rare lymphoma, and more than 33 have died,” the article states. “Hundreds of thousands of others are estimated to be at risk of developing the disease, which can take decades to surface and has been linked to textured implants in academic studies. Cases of the lymphoma have been reported in women with implants from various manufacturers, including Johnson & Johnson and Sientra. But Allergan’s Biocell implants have by far the worst record of affected patients. By the end of 2018, European regulators stopped Allergan from selling textured implants. The FDA was slower to respond, but in July 2019 it finally asked Allergan to recall those devices from the market, citing BIA-ALCL. The company complied and suspended future sales.” These latest litigation efforts will no doubt be looking back to the science developed more than 20 years indicating the possibility that breast implants could cause immune-mediated cancers in support of patients’ claims that the products are defective, that warnings accompanying the products should have been stronger, that more safety studies should have been properly completed, and/or that the products should not have been sold at all as the were unreasonably dangerous to patients.
Searcy Denney Scarola Barnhart & Shipley has been involved in representing patients injured by defective breast implants for more than 25 years. For more information, please contact our office for a free legal consultation.