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by Dr. Gregory T. Lynam

Large Cell Lymphoma

can occur as a result of breast reconstruction after
a diagnosis of breast cancer or as a result of cosmetic
surgery using textured silicone implants.

What is Breast Implant Associated Anaplastic Large-Cell Lymphoma (BIA-ALCL)?

A rare subtype of ALCL has been identified in women who have textured silicone breast implants (protheses). This is known as breast implant associated anaplastic large cell lymphoma, or BIA-ALCL. It can occur as a result of breast reconstruction after a diagnosis of breast cancer or as a result of cosmetic surgery using textured silicone implants. BIA-ALCL initially occurs in the fluid contained within the scar capsule surrounding the implant, rather than the breast tissue itself.

In 2011, the FDA identified a possible association between breast implants and the development of anaplastic large cell lymphoma (ALCL).Although ALCL is extremely rare, the FDA believes that women with breast implants have a risk of developing breast implant-associated anaplastic large cell lymphoma, or BIA-ALCL. 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. According to the World Health Organization, BIA-ALCL is a T-cell lymphoma that can develop following breast implants. Anaplastic Large Cell Lymphoma is a type of non-Hodgkin’s lymphoma, a cancer of the cells of the immune system. It can occur in many different parts of the body, including the lymph nodes and skin. Even though BIA-ALCL is found in the breasts of some individuals (cis- and trans-gender women and men) with breast implants, it is not breast cancer.
http://wayback.archive-it.org/7993/20171115053750/https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/BreastImplants/ucm239996.htm

Prognosis

According to the American Society of Plastic Surgery:
Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) is a rare and highly treatable type of lymphoma that can develop around breast implants. BIA-ALCL occurs most frequently in patients who have breast implants with textured surfaces…Since the initial case report in 1996, ASPS now recognize approximately 265 cases in the US and a total of 673 worldwide as of January 25, 2019.

Most of the patients who have developed BIA-ALCL receive an excellent prognosis following surgical removal of the breast implants and the surrounding scar tissue capsule. Continued follow-up after any breast implant surgery is suggested and important for patient health, but patients who notice pain, lumps, swelling, fluid collections or unexpected changes in breast shape, including asymmetry, should contact their plastic surgeon. In most cases, women diagnosed with BIA-ALCL observed changes in the look or feel of the area surrounding the implant greater than one year after their initial surgical sites were fully healed, and on average eight to ten years after receiving textured implants.

Patients undergoing plastic surgery procedures, aesthetic or reconstructive, should be thoroughly informed of the potential risks and possible complications known to be associated with the procedure, and any device used in that procedure. In the very rare cases where a diagnosis of BIA-ALCL is made, surgical treatment is essential for the management of the disease. Some patients with more advanced disease may require further treatment such as chemotherapy.
https://www.plasticsurgery.org/for-medical-professionals/health-policy/bia-alcl-physician-resources

In 2017, the U.S. Food and Drug Administration (FDA) updated its 2011 warning about a link between breast implants and a very rare form of cancer: anaplastic large-cell lymphoma. Because the cancer is linked to breast implants, the FDA calls the cancer breast implant-associated anaplastic large-cell lymphoma (BIA-ALCL).If BIA-ALCL develops after a breast implant is placed, the lymphoma is almost always only in the capsule of scar tissue that forms around the implant. So, the BIA-ALCL usually can be successfully treated by removing the implant and the scar tissue capsule. Additional treatments such as radiation therapy and chemotherapy usually aren’t needed but may be recommended in some cases.While the exact number of cases of BIA-ALCL has been difficult to figure out because of limited worldwide reporting, the FDA did say that it had received 359 reports of the cancer and that nine women had died from the disease.

The risk of BIA-ALCL is higher in women who have textured implants, which have a bumpy surface, as opposed to smooth implants, according to the FDA.Doctors estimate that anaplastic large-cell lymphoma is diagnosed in one of every 500,000 women, making it very uncommon. Anaplastic large-cell lymphoma can develop in other places in the body besides the breast. A BIA-ALCL diagnosis is quite rare: out of 100 million women, it’s estimated that only 3 cases would be diagnosed in a year.Most of the women who were diagnosed went to their doctors and were diagnosed with BIA-ALCL because fluid had collected around the implant (called a seroma) YEARS after the implant was placed. In some cases, testing the seroma fluid led to the diagnosis. In other cases, BIA-ALCL was diagnosed after a mass was found in the breast or because the tissue capsule tightened (called capsular contracture) and caused discomfort or cosmetic problems.

If you have an implant, the FDA recommends:
• regular monitoring for symptoms of BIA-ALCL
• if you have no symptoms of BIA-ALCL, there is no need to remove the implant and no need to change your routine medical care and follow up
https://www.breastcancer.org/research-news/study-estimates-risk-of-rare-cancer-from-implants

Per the FDA, there is a possible association between breast implants and ALCL. Based on available data, the incidence of ALCL, even in breast implant patients, appears to be very low. However, despite the low total number of reported cases, certain factors suggest the occurrence of ALCL in patients with breast implants may not be coincidence. If ALCL in women with breast implants were due only to chance, one would expect for it to occur with similar frequency in all parts of the breast. Instead, ALCL is usually located in the region immediately surrounding the breast implant. Furthermore, the vast majority of primary breast lymphomas reported in patients without breast implants are of the B-cell phenotype. In contrast, ALCL is a T-cell lymphoma, suggesting the observation may be more than chance.
http://wayback.archive-it.org/7993/20171115053750/https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/BreastImplants/ucm239996.htm

Does the fill of the breast implant–silicone versus saline–increase an individual’s risk of developing BIA-ALCL?

The type of implant fill does not appear to be a risk factor for BIA-ALCL.
https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/BreastImplants/ucm241086.htm

Where in the breast is the ALCL usually located?

If BIA-ALCL develops after a breast implant is placed, the lymphoma is almost always only in the capsule of scar tissue that forms around the implant. So, the BIA-ALCL usually can be successfully treated by removing the implant and the scar tissue capsule. Additional treatments such as radiation therapy and chemotherapy usually aren’t needed but may be recommended in some cases. https://www.breastcancer.org/research-news/fda-updates-on-textured-implants-and-cancer

Where in the breast has BIA-ALCL been found?

BIA-ALCL is usually found near the breast implant, contained within the fibrous scar capsule, and not in the breast tissue itself. In most cases, the ALCL cells were found in the fluid surrounding the implant (seroma) or contained within the fibrous scar capsule.
https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/BreastImplants/ucm241086.htm

What are the symptoms of BIA-ALCL?

The main symptoms of BIA-ALCL are persistent swelling or pain in the vicinity of the breast implant. These symptoms may occur well after the surgical incision has healed, often years after implant placement. Upon evaluation by a health care provider, evidence of fluid collection around the breast implant (seroma) is often observed. Some patient reports indicated that a lump under the skin or capsular contracture (thick and noticeable scar capsule around the implant) were present.

What are the characteristics of BIA-ALCL?

ALCL is characterized by abnormal growth of T-lymphocytes (T-cells) and strong expression of a protein, cytokine receptor CD30. ALCL can involve many parts of the body, including the lymph nodes and skin. There are currently two major variants of ALCL recognized in the literature, one of which expresses the protein anaplastic lymphoma kinase (ALK-positive) and a second which does not (ALK-negative).

What are the risks of ALCL?

According to the FDA, precise risks are difficult to determine due to lack of information about how many patients have received breast implants in the US and worldwide.Over time, the FDA has strengthened their understanding of this condition. In 2016, the World Health Organization designated breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) as a T-cell lymphoma that can develop following breast implants. The exact number of cases remains difficult to determine due to significant limitations in world-wide reporting and lack of global breast implant sales data. At this time, most data suggest that BIA-ALCL occurs more frequently following implantation of breast implants with textured surfaces rather than those with smooth surfaces.

Diagnosis

The diagnosis of ALCL requires the examination by a pathologist of any enlarged lymph node, or any affected extranodal tissue where there the tumor is found, such as the intestine, the liver or bone in the case of systemic ALCL. For the case of cutaneous ALCL, a skin excision is recommended, and for the diagnosis of ALCL associated with breast implants, a cytologic specimen of the effusion around the breast implant or complete examination of the breast capsule surrounding the implant is required.

Am I at risk?

ALCL is rare…Most patients were diagnosed when they sought medical treatment for implant-related symptoms such as persistent seromas, capsular contractures, or peri-implant masses warranting breast implant revision operations. In each case, lymphoma cells were found in the effusion fluid (seroma) surrounding the implant, in the fibrous capsule, or within a peri-implant mass. Typically, there was no invasion beyond the fibrous capsule into the breast parenchyma. As of September 30, 2017, the FDA has received a total of 414 medical device reports (MDRs) of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), including 9 deaths1. BIA-ALCL are counted for those with a confirmed pathology test, or ALK or CD30 biomarkers, or reported by health care professionals. There are 272 reports with data on surface information at the time of reporting. Of these, 242 were on textured implants and 30 on smooth implants. There are 413 reports with data on implant fill type. Of these, 234 reported the use of silicone gel-filled implants, and 179 reported the use of saline-filled implants.
https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/BreastImplants/ucm481899.htm

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