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Amid continuing concerns about the risk of cancer from textured breast implants, new research suggests most cases of breast-implant associated anaplastic large cell lymphoma (BIA-ALCL) are effectively cured by removal and a partial capsulectomy.
In a study presented at the annual meeting of the American Society of Hematology, researchers at Memorial Sloan Kettering Cancer Center (MSKCC) in New York evaluated the effectiveness of treatment for rare cases of lymphoma which have developed in the tissue surrounding certain types of implants.
According to the findings, more than 90% of all cases of breast implant ALCL were linked to Allergan Biocell textured implants, which featured a macrotextured design recalled from the market in 2019.
Researchers followed up with women diagnosed with BIA-ALCL who underwent breast implant removal and capsulectomy, finding nearly 9 out of 10 women did not see the disease return or progress, and more than 90% survived for at least two years.
Since the Allergan breast implant recalls were first announced, hundreds of cases of BIA-ALCL have been identified nationwide, which are believed to be caused by chronic inflammation from the textured design. However, there has been little guidance for women who still have the breast implants in their body, or those diagnosed with the rare cancer.
The standard treatment has been to have the breast implants removed, as well as the removal of the capsule of fluid and tissue surrounding the implant. In this latest study, researchers conducted follow up on women who had undergone the procedure, looking for recurrence and survival rates.
Researchers retrospectively analyzed 18 cases of women undergoing the procedure at MSKCC from January 2011 through January 2020. The women were followed for a median of 26 months, with a clinical exam conducted every three to six months.
According to the findings, 17 of the 18 women diagnosed with breast implant lymphoma had Allergan’s Biocell textured breast implants. In the one remaining case, the source of the breast implant was unknown. Three of the 18 cases had higher stage cancer which required additional treatment beyond implant removal, such as chemotherapy.
None of the patients died of lymphoma progression and none had a recurrence, according to the findings. One woman died, but it was of conventional breast cancer and not BIA-ALCL, according to researchers. The overall survival rate was 94% at two years, and progression free survival was 89% at two years.
“Our data on this cohort of patients with BIA-ALCL surgically treated and followed at a single institution, confirm the importance of adequate surgery (bilateral implant removal and complete capsulectomy) in patients presenting with seroma-confirmed disease,” the researchers concluded. “This dataset reinforces the high rates of progression free and overall survival when diagnosis is identified and treatment performed in those with limited stage disease.”
The study comes as Allergan faces a growing number of breast implant lawsuits filed by women diagnosed with the rare cancer, as well as women who have required removal of the recalled implants due to concerns that they may develop the lymphoma in the future. The complaints all raise similar allegations that the manufacturer knew about problems associated with the textured design for years, yet failed to warn women, the medical community or federal regulators, continuing to promote the textured design as safe and effective.
There are currently at least 300 class action and product liability lawsuits filed throughout the federal court system, which have been consolidated for pretrial proceedings in New Jersey. However, as breast implant cancer lawyers continue to review and file claims in the coming weeks and months, the size and scope of the litigation is expected to continue to grow.