The FDA reports this week a rise in the number of cases of BIA-ALCL, anaplastic large cell lymphoma by 9%.
On their website they report the following:
After a thorough data analysis, we are reporting that, as of September 2018, the agency has received a total of 660 total medical device reports regarding BIA-ALCL cases in the U.S. since 2010. Of the 660 MDRs, our in-depth analysis suggests that there are 457 unique cases of BIA-ALCL, including 9 patient deaths.
Last year the FDA reported 9 women had died from anaplastic large cell lymphoma (BIA-ALCL) possibly associated with their breast implant use. At the time, the FDA received 359 reports of BIA-ALCL, a rare type of non-Hodgkins lymphoma, 9 of whom died as of February 1, 2017. This year the FDA reported 457 cases, up from 415 cases last year.
In 2017 a study from the Pennsylvania State University College of Medicine linked textured breast implants to this malignant cancer.
Although a rare cancer. researchers believe the lifetime risk is 1 out of every 30,000 women with breast implants and if the numbers are underreported, could be as common as 1 out of every 4000 women with implants.
Although the implants are used to augment breast tissue, the malignancy is not a breast cancer but rather a lymphoma.
Lymphomas make up the most common of the blood cancers. The cancer begins in the lymphocytes, cells crucial for maintaining one’s immune system. Two main types of lymphoma are Hodgkin’s and Non Hodgkins. Non Hodgkins is more common, and anaplastic large cell lymphoma is a subset if it.
ANAPLASTIC LARGE CELL LYMPHOMA/PATHPEDIA.COM
According to the American Society of Plastic Surgeons , there were currently 195 cases in the US and a total of 521 worldwide as of March 21, 2018. Updated numbers are not available.
This is not the first time a link has been suggested. 6 years ago the World Health Organization suggested a link. Then in 2011, the FDA identified a possible association between the two. In 2016, the Australian Therapeutic Goods Administration reported 46 confirmed cases with 3 deaths relating to breast implants.
The report last spring suggested that BIA-ALCL affected both smooth and textured implants. According to the FDA report, 231 of the 359 cancer cases provided information on implant type. 203 were reported to be textured implants and 28 reported to be smooth implants. When it came to silicone vs. saline implants, the FDA said 312 of the 359 reports provided these specifics and of those 186 reported implants filled with silicone gel and 126 reported implants filled with saline.
So neither implant type appeared immune to the risk of BIA-ALCL but it appears the silicone, textured implants carried the most risk.
Now the cancer occurred within the breast and the FDA advises physicians to consider the possibility of BIA-ALCL if there appears to be a seroma (fluid filled cavity around the implant) or a contracture (pulling of the skin and tissue) near the implant.
In most cases the cancer is treatable, with removal of the implant and the surrounding tissue curative. In some cases however, radiation of the area or chemotherapy is required.
Although 50,000 cases of non-Hodgkins lymphoma occurs annually in the US, it is unknown how many cases of BIA-ALCL occur each year. Moreover, many countries may not have avid reporting systems of breast implant related cancers as we do. According to the American College of Plastic Surgeons, close to 300,000 women receive breast implants each year, some of which for breast reconstruction after mastectomy for breast cancer.
The FDA reminds us that BIA-ALCL is rare and prophylactic breast implant removal is NOT recommended. However we need to be aware and evaluate if one develops swelling, pain, new lumps or asymmetry in the breasts….just as we do for those without implants.
For healthcare providers, they recommend the following:
Prior to implantation, provide all patients with the breast implant manufacturer’s labeling, including the patient-specific labeling, as well as other educational material prior, and make sure they are aware of the benefits and risks of the different types of implants. Most confirmed cases of BIA-ALCL have occurred in patients with textured surface implants, although there are known cases in patients with only smooth-surface breast implants.
Consider the possibility of BIA-ALCL when treating a patient with late onset, peri-implant seroma. In some cases, patients presented with a mass or masses adjacent to the breast implant. If you have a patient with suspected BIA-ALCL, refer the individual’s case to a multidisciplinary team for evaluation.
Collect fresh seroma fluid and representative portions of the capsule and send for pathology tests to rule out BIA-ALCL. Diagnostic evaluation should include cytological evaluation of seroma fluid or mass with Wright Giemsa stained smears and cell block immunohistochemistry/flow cytometry testing for cluster of differentiation (CD30) and Anaplastic Lymphoma Kinase (ALK) markers.
Develop an individualized treatment plan in coordination with the patient’s multi-disciplinary care team. Consider current clinical practice guidelines, such as those from the Plastic Surgery Foundation or the National Comprehensive Cancer Network (NCCN) when choosing your treatment approach.
Report all confirmed cases of BIA-ALCL in individuals with breast implants to MedWatch, the FDA Safety Information and Adverse Event Reporting program.
Health care personnel employed by facilities that are subject to FDA’s user facility reporting requirements should follow the reporting procedures established by their facilities. Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices. In some cases, the FDA may contact you for additional information. The FDA will keep the identities of the reporter and the patient confidential.
Submit case reports of BIA-ALCL to the Patient Registry and Outcomes For breast Implants and anaplastic large cell Lymphoma etiology and Epidemiology (PROFILE) Registry to contribute to a better understanding of the causes and treatments of BIA-ALCL.