Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL)
Anaplastic large cell lymphoma (ALCL) is a rare type of non-Hodgkin lymphoma. Non-Hodgkin lymphoma is a cancer that originates from lymphatic cells, which are part of your immune system (the system which fights infections). It is not a cancer of the breast tissue such as breast cancer. There have been case reports of women with breast implants developing breast implant-associated ALCL (BIA-ALCL) around the world. BIA-ALCL develops in the breast mostly as a seroma surrounding the implant and in the scar tissue, but typically contained within the fibrous capsule (if detected in the early stages), or more rarely as a solid mass that can become invasive infiltrating the chest wall and muscle, in some instances spreading to adjacent lymph nodes, in these cases having a far worse prognosis.
At this time, data suggest that BIA-ALCL occurs more frequently following implantation of breast implants with textured surfaces but also occurs in those with smooth surfaces. It is suspected the number of cases is underreported due to the lack of sufficient research and data related to breast implants overall.
The FDA confirms that both silicone gel and saline implants have been reported in cases of BIA-ALCL.
It is known that a large number of chemically active agents from metals to vinyl derivatives, and a number of aromatic hydrocarbons i.e. benzol and xylol, have been detected in implant gels and exudates, and it has been proven that the main components of the implants may leech or ooze from the implants into the surrounding tissue. In addition, the various detected metals may also directly induce oxidative stress and damage DNA which over a prolonged period may express several bio-transforming cytochrome P450 enzymes (CYP 1Aa/2 and 1B1), and ultimately may produce mutagenic reactive species from the aromatics.
Additional information
At this point, many governments are communicating that people with breast implants have a low but increased risk of developing BIA-ALCL. The exact incidence of BIA-ALCL is unknown and varies widely in the literature. Available data in Canada and internationally suggest that the risk of BIA-ALCL is higher with implants having a textured surface, especially those with a more highly textured surface rather than the one with a less textured or a smooth surface. To make matters more complicated overall, many of the reported cases to date indicate the type of implant was unknown, thus rendering interpretation of the data difficult.
The newest generation of implants most recently on the market have been designed to provide an anatomically pleasing shape with the overall intention of reducing the rate of capsular contracture and preventing rotation. These types of features have been provided by implants with textured surfaces, which are attributable to the large majority of BIA-ALCL cases (including global manufacturing breast implant companies such as Allergan).
Statistics show that approximately 1.7 million patients every year elect breast implant surgery with the assumption that with all the latest advancements in technology, the risks are lessening. However, it is quite the opposite. What we are beginning to reveal in 2019, is that the overall risks are significant and furthermore, highly under-reported. Failure to identify breast implant-related illnesses by patients, medical professionals, aesthetic medical device manufacturers, regulators, and more, makes it difficult to estimate the real numbers of associated risks and outcomes. As patients, we all need to be diligent and make informed decisions. If you have any doubts whatsoever, we need to unite as one and demand answers.
Allergan recalls
On December 19, 2018 Allergan sent out a notice to the European market informing of their sales suspension notice regarding their textured breast implants in the Ireland. Included in the original notice is a complete list of the textured breast implants & tissue expanders being recalled.
On May 27, 2019 following a safety review on BIA-ALCL, Health Canada suspended the licences for Allergan’s Biocell breast implants (the only macro-textured implants available in Canada) based on an unacceptable level of risk of BIA-ALCL with macro-textured breast implants.
On July 24, 2019 Allergan announced a voluntary worldwide recall of BIOCELL® textured breast implants and tissue expanders due to the increase in the number of BIA-ALCL cases related directly to their aesthetic medical devices.
Causes
The aetiology (the cause or set of causes) of BIA-ALCL is unclear, but the consistent association of breast implants with this distinct tumour entity lends some clues. In addition, the co-expression of CD30, a protein essential in the diagnosis of ALCL and normally found on activated T cells, further hints towards activated T cells being the origin of this disease.
Areas of ongoing medical research include:
surface texture
trauma to the breast
chronic inflammation
bacterial contamination
genetic predispositions
understanding the lack of reported cases in some populations (such as Asian women) and/or possible links to genetics
hardening of scar tissue that can form around breast implants
while breast surgery is considered a ‘clean contaminated site’, infection at the site of the implant may also be a contributing factor
a possible association with chronic infection as a contributing factor
further studies are required to determine whether BIA-ALCL is a new genetic subgroup of systemic ALCL
Symptoms
BIA-ALCL most often presents as a sudden swelling or enlargement of the breast, pain, and/or rash. This may develop many months or years following an initial breast implant procedure. It is called a delayed seroma. Key symptoms including capsule thickening and capsular contracture characteristically manifesting as unilateral breast enlargement. Enlarged lymph node excision biopsies followed by histopathological analyses can also aid in diagnosis.
Cases of BIA-ALCL may also present with these symptoms:
pain in or around the breast
a lump/mass in the breast or breast area and/or under the armpit
a change in breast shape or implant shape
an increase in breast size
the development of or an increase in breast asymmetry
a change in the way the breast feels such as an increase in firmness
capsular contracture
skin changes such as dermatitis and/or lesions of the breast or breast area
enlarged axillary lymph nodes
fever
chronic severe fatigue
nightsweats
MRI and/or ultrasound results displaying fluid around the breast implant and/or masses or areas of increased thickness of the scar tissue/capsule
other symptoms developing months to years following an initial implant surgery
Regularly examine your breast for changes
Patients with breast implants should regularly examine their breasts for changes. Patients with any signs or symptoms should discuss them with a health care provider immediately. Many plastic surgeons also recommend that patients receive MRI screening every 2 years after breast implants.
BIA-ALCL can be investigated with an ultrasound of the breasts, chest wall and regional lymph nodes. When an ultrasound is inconclusive, magnetic resonance imaging (MRI) or computed tomography scans may assist with the diagnosis of soft tissue masses. When fluid is detected within the capsule, ultrasound-guided aspiration of seroma fluid with subsequent cytology, flow cytometry and analysis of the cells, primarily for CD30 expression and negativity for ALK helps to establish the diagnosis.
Treatment
What is clear is that complete capsulectomy, complete implant and capsule removal including scar tissue around the implant, is required for treatment of BIA-ALCL, which for early-stage disease leads to cure. However, chemotherapy and/or radiation is needed for advanced-stage disease, whereby improved results have been reported with the use of brentuximab.
Unfortunately, deaths have also been reported including cases where the implant has been removed and the capsule was left behind. It is important to detect symptoms and diagnose BIA-ALCL as soon as possible in order to conduct treatment and not allow the cancer to metastasize to surrounding tissues, organs, bones, lymph nodes, etc.
Other Concerns About Risk
There is currently insufficient evidence/data to show that breast implants cause:
connective tissue disease; and/or
increased illness in children of women with breast implants.
There are still so many unknown risks clearly associated with all types of breast implants. What is clear to us is that ALL cases should be diligently reported to their respective authorities and all patients should be informed of the risks - no matter how small.
All posts are intended strictly for educational purposes. It is not intended to make any representations or warranties about the outcome of any procedure. It is not a substitute for a thorough in-person consultation with a medical professional. If you have questions about your personal medical situation, please call your healthcare provider.
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