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Capsule


As of March 22, 2023, health care providers can submit case reports of SCC, various lymphomas, and any other cancers in the capsule around breast implants to the Patient Registry and Outcomes for Breast Implants and Anaplastic Large Cell Lymphoma (ALCL) Etiology and Epidemiology (PROFILE) Registry, a collaborative effort between the American Society of Plastic Surgeons (ASPS), the Plastic Surgery Foundation (PSF), and FDA. Health care providers can continue to submit case reports of Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) to PROFILE as well.




Capsule


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The FDA reviews data from the PROFILE registry on an ongoing basis to gather all available information on cancers in the capsule around breast implants, and will keep the public informed on significant findings as new information becomes available.


The U.S. Food and Drug Administration (FDA) is providing an update on reports of squamous cell carcinoma (SCC) in the scar tissue (capsule) that forms around breast implants. Previously, on September 8, 2022, the FDA released a safety communication informing the public of reports of cancers, including SCC and various lymphomas, in the capsule that forms around breast implants. The various lymphomas are not the same as the lymphomas described previously by the FDA as Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL).


In general, the diagnosis was established by pathology examination of the capsule tissue. Imaging studies were often used in the diagnostic workup such as computed tomography (CT) of the chest, or magnetic resonance imaging (MRI) of the breast, or CT in combination with positron emission tomography (PET) as a PET-CT. The diagnosis of SCC in the capsule around the breast implant occurred approximately 7 to 42 years (when data was available) after initial implant placement. SCC was located in the capsule around the breast implant often in the posterior aspect (behind the implant) without being present in the breast tissue. Three reports of death due to the disease were reported in the literature.


In summary, there have been reports in the literature of SCC in the capsule around the breast implant for both textured and smooth breast implants, and for both saline and silicone breast implants, when implant information was available. In most cases, people were diagnosed years after initial implant placement.


As of January 15, 2023, the FDA has received 24 medical device reports (MDRs) about SCC related to breast implants. The FDA recognizes the limitations of MDR data, including duplicate reporting of cases within the MDRs, and between the MDRs and the literature. Therefore, MDRs do not necessarily represent unique cases. In addition, the incidence of SCC in the capsule around breast implants cannot be determined from this reporting system alone due to potential under-reporting, duplicate reporting of events, and the lack of information about the total number of patients who have breast implants. Based on review of the MDRs, the information described about SCC related to breast implants is similar to information from the literature for patient age, implant type, reason for implant, time to diagnoses, and clinical presentation.


The FDA continues to collect and evaluate all available information about SCC, lymphomas, and any other cancers in the capsule around the breast implant. We are collaborating with other regulatory authorities, clinical and scientific experts, professional societies, manufacturers, and breast implant registries, to increase awareness of SCC in the capsule around the breast implant. In addition, the FDA is working with breast implant manufacturers to help ensure that patients receive and understand information about this emerging issue. The FDA continues our collaborative efforts with the American Society of Plastic Surgeons (ASPS) and the Plastic Surgery Foundation (PSF) to better characterize these cancers in people with breast implants.


The internal capsule (IC) is a subcortical white matter structure situated in the inferomedial portion of each cerebral hemisphere. It is composed of myelinated ascending and descending fiber tracts that course past the basal ganglia to connect the cerebral hemispheres with subcortical structures, the brainstem, and the spinal cord. As it traverses the basal ganglia structures, it divides the caudate nucleus and thalamus from the putamen and globus pallidus. Anatomically, the internal capsule can be divided into the anterior limb, genu, posterior limb, retrolenticular segment, and sublenticular segment.[1][2][3]


The various portions of the internal capsule primarily receive their vascular supply from perforating arteries that arise from the anterior cerebral artery, middle cerebral artery, anterior choroidal artery, and the internal carotid artery. These perforating arteries are prone to lipohyalinosis leading to ischemic damage of areas of the internal capsule resulting in clinically significant motor and sensory deficits.[4]


The internal capsule is a two-way tract for the transmission of information to and from the cerebral cortex. It lies in the inferomedial portion of each cerebral hemisphere. On transverse sections of the brain, the internal capsule is a V-shaped structure with the apex pointing medially. The lentiform nucleus forms the lateral bounds of the internal capsule, while the thalamus and caudate form the medial bounds. Above the superior border of the lentiform nucleus, the fibers of the internal capsule arrange in a radiating pattern known as the corona radiata.[2]


Fibers of the corona radiata travel caudally and become densely packed to form the internal capsule. The fibers become even more densely packed as they continue past the basal ganglia, forming the basis pedunculi at the midbrain. As the axons from the internal capsule travel down the brain, their numbers decrease as many descending axonal tracts terminate in the thalamus and various other nuclei in the brainstem. The internal capsule subdivides into the anterior limb, genu, posterior limb, retrolenticular segment, and sublenticular segment. Each portion of the internal capsule carries distinct ascending and descending axonal tracts that each have critical functions.[1][2]


The internal capsule's anterior limb is bounded by the head of the caudate nucleus medially and the lentiform nucleus laterally. The anterior limb contains fibers of the anterior thalamic radiation and frontopontine fibers.[1] Anterior thalamic radiation fibers connect the anterior and medial thalamus with the prefrontal cortex and the cingulate gyrus.[5] Frontopontine fibers originate from the frontal lobe and terminate in pontine nuclei.[6] The anterior limb also contains fiber tracts that travel transversely between the caudate nucleus and the putamen. Fiber tracts in the anterior limb are associated with processing emotion, cognition, decision making, and motivation.[7] Abnormalities in the white matter of the anterior limb are seen to be abnormal in psychiatric illnesses such as schizophrenia, bipolar disorder, and obsessive-compulsive disorder.[7]


The internal capsule's posterior limb is bounded by the thalamus medially and the lentiform nucleus laterally. The posterior limb contains fibers of the posterior thalamic radiation, corticospinal tract, corticorubral tract, and corticopontine tract.[1] The anterior half of the posterior limb contains the corticospinal tract, corticorubral tract, and corticopontine tract. The corticospinal tract originates from the primary motor cortex and premotor areas. Fibers from the premotor areas are situated rostrally to fibers from the primary motor cortex.[8]


The dentatothalamic tract from the dentate nucleus end by synapsing with cells in the contralateral ventrolateral nucleus of the thalamus. The axons of the thalamic neurons ascend through the internal capsule to terminate in the primary motor area of the cerebral cortex. Through this pathway, the dentate influences motor activity on the same side of the body by acting on the motor neurons of the opposite cerebral cortex.[2] Furthermore, these descending fibers from the cerebral cortex converge in the corona radiata and pass through the posterior limb of the internal capsule. At this level, the fibers closest to the genu correlate with the cervical portions of the body, while those situated more posteriorly correlate with the lower extremity. As the tract courses through the midbrain, it constitutes the middle three-fifths of the basis pedunculi. Here, the fibers are arranged with the cervical portions of the body situated medially, and fibers representing the lower extremity are placed laterally.[2][3]


The location of the genu of the internal capsule is at the apex of the pallidal part of the lentiform nucleus. The anterior and posterior limbs join at a right angle in this region to form the genu.[1]. Tracts that course through the genu include superior thalamic radiation fibers and corticobulbar tract fibers. Corticobulbar tract fibers originate from the primary motor cortex, premotor cortex, and supplementary motor areas. They course through the genu and terminate at the appropriate cranial nerve nuclei within the brainstem. The corticobulbar tract controls the muscles of the face and neck. This tract is necessary for the movement of facial musculature, mastication, and swallowing. The superior thalamic radiation fibers connect ventral nuclear group thalamic nuclei with the postcentral gyrus and appear to carry somaesthetic sensations that pass through the thalamus.[12]


The location of the sublenticular segment of the internal capsule is below the lentiform nucleus. This area contains auditory radiation fibers which course from the medial geniculate body and terminate in the transverse temporal gyri of Heschl. The retrolenticular segment of the internal capsule is around the posterior edge of the lentiform nucleus. It contains fibers of the optic radiation which connect the lateral geniculate nucleus to the calcarine fissure (a.k.a geniculocalcarine radiations). Parts of the optic radiation also course through the sublenticular segment of the internal capsule. The optic radiation transmits visual information from the retina to the visual cortex.[2] 041b061a72


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