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Amid increasing concerns about the risk of cancer from breast implants, a new study reveals that every confirmed case of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) was linked to products with textured surfaces, suggesting that the rare cancer may be caused either by the implant’s interaction with the immune system or due to allergic reactions.
Researchers with the University of Southern California published a review of all known breast implant cancer data in the Journal of Surgical Oncology on August 1, looking at all available literature, including 85 case reports, and provides a summary of the known data.
The findings indicate that knowledge of breast implant lymphoma risk has greatly increased since the first reports in 2011, but research still has a number of unanswered questions. While it has been generally concluded that BIA-ALCL is caused by breast implants, the researchers note that no causal link has been identified.
Researchers looked at 391 scientific articles, including 85 case results. They found that the average age of patients was 53.6 years, and women had the implants in for an average of 9.9 years before being diagnosed with BIA-ALCL. Most cases presented as breast swelling, tenderness, skin manifestations, fevers, chills, weight loss and night sweats.
Finding a cause for the problem has been difficult. According to their study, there is some evidence that some women are more genetically susceptible, but it has not been proven.
“There is no consensus on the pathogenesis of BIA-ALCL, although many theories have been proposed. Chronic but mild stimulation of the immune system due to the implant or bacteria around the implant are the most commonly proposed etiologies,” the researchers wrote. “Allergic reaction to the implant has also been proposed as a possible etiology due to the presence of interleukin-13, a cytokine associated with allergic inflammation.”
Researchers determined that all confirmed cases of BIA-ALCL have involved textured breast implants. While there have been reports of the condition arising in patients with smooth implants, mainly through the FDA’s Medical Device Reports, none of those cases has been confirmed. The true incidence rate of BIA-ALCL is still unknown, but believed to be extremely rare, the researchers concluded.
However, questions remain regarding what to tell patients, and on whether patients who have had their breast implants removed, as this has repeatedly been shown to be the best way to treat BIA-ALCL, should risk undergoing breast reconstruction again.
“The most important aspect of analysis of BIA-ALCL is informing the patients who will ultimately undergo breast augmentation or reconstruction of what their eventual risk may be,” the researchers determined. “The cost to patients, both in terms of anxiety over the possibility of disease and the avoidance of interventions that can improve quality of life, must be considered as part of the ongoing investigation of BIA-ALCL.”
Breast Implant Recall
The report came shortly after the FDA announced that Allergan had agreed to issue a worldwide breast implant recall for all of its Biocell microtextured products, which have been linked to the rare form of lymphoma that is known to develop in the tissue surrounding certain textured breast implants.
The FDA indicates there are at least 573 known cases of breast implant ALCL diagnosed worldwide, including at least 33 deaths. Of those, 481 have been linked to Allergan breast implants, which have also been linked to at least 12 of the 13 deaths where the manufacturer of the breast implant was known.
For women who have the recalled Allergan breast implants, the FDA is not recommending removal of the device if they are not showing symptoms. Instead, the regulators recommend recipients of these implants become familiar with the symptoms of ALCL, including persistent swelling or pain near the implant, and talk to their health care provider for further information. Those diagnosed with ALCL should undergo breast implant removal and removal of the surrounding scar capsule, according to the latest recommendations from health regulators.
The FDA also recommends those who receive breast implants keep a record of the device manufacturer, unique device identifier and implant model name, which may have been provided on a patient device card from the surgeon.
Those with questions regarding the safety communication can email the Division of Industry and Consumer Education (DICE) at DICE@FDA.HHS.GOV or by calling 800-638-2041 or 301-796-7100.
There are a growing number of breast implant cancer lawsuits being pursued against Allergan by women throughout the United States, including several class action lawsuits seeking money for medical monitoring.