The Spanish Agency for Medicines and Health Products (AEMPS) has received notification of 129 suspicions of cases anaplastic large cell lymphoma (ALCL) associated with breast implants in Spain until 2023 and since 2012, when the first incident was known. Of these suspicions, the agency dependent on the Ministry of Health reports, 94 cases have been confirmed. The community with the most notifications is Madrid, followed by Catalonia and the Valencian Community.
Anaplastic large cell lymphoma (also called ALCL, Anaplastic Large-Cell Lymphoma) is a rare type Non-Hodgkin lymphoma which affects a wide variety of tissues including the breast, describes the AEMPS. Currently, it is included within a category of lymphoproliferative disorders with a wide spectrum of clinical behaviors and in recent years the appearance of the disease associated with breast implants.
The disease associated with breast prostheses develops from the lymphocytes that participate in the formation of the fibrous capsule that forms around the implant.
The disease associated with breast prostheses develops from the lymphocytes that participate in the formation of the fibrous capsule. that forms around the implant, as a consequence of the body’s reaction to a foreign body. The AEMPS annually publishes a report that discloses the results obtained from the evaluation of the notifications received within the framework of the Health Products Surveillance System. The latest document was published this Monday.
Benign clinical course
Most cases associated with breast implants had a benign clinical course after the withdrawal of the periprosthetic capsule and prosthesesalthough, in some cases, the AEMPS points out, they needed treatment, which depended on the clinical stage. Even so, four cases of death have been reported since the beginning of follow-up.
The estimated number of women implanted in Spain since 2012, the date on which the first case was reported, is 581,000, so “the incidence of this disease is low”
To contextualize the notifications received of cases of lymphoma associated with breast implants, the AEMPS recalls that “it is important” to indicate that the estimated number of women implanted in Spain since 2012the date on which the first case was reported, is 581,000, so “the incidence of this disease is low.”
Madrid, at the head
The community with the most notifications at this time is Madrid, with 21 confirmed cases out of 32 notifications, followed by Catalonia and Valencian Community, both with 13 confirmed cases out of 18 reported; They are followed by Andalusia with 19 notifications and 12 confirmations; Murcia, with 6 notifications and six confirmations; canary with 5 confirmations; Basque Country with 4 confirmations and Balearic Islands with four and 3 confirmations.
Additionally, Castilla y León, with 3 confirmations; Aragón with 2 confirmations; Cantabria with two notifications and one confirmation; Asturias, Castilla-La Mancha and Navarra with one confirmation each; Galicia, with an unconfirmed notification. And of unknown origin, the AEMPS specifies, 11 notifications and 8 confirmations are recorded.
Reconstruction and aesthetics
Regarding the cases that have been confirmed, the indication for which the patients were carriers of breast implants, in 22 of the 94 confirmed cases, was due to the need for reconstruction after mastectomy; 40 They were for aesthetic reasons and in the rest of the cases, the Agency does not have information.
When the identification of the implant has been collected, it has been found that this lymphoma is more frequently associated with prostheses that have a textured cover vs. smooth cover. However, it must be taken into account that until a few years ago they were also the most used breast prostheses. Of the 94 confirmed cases, 77 referred to prostheses with a textured cover, 3 to polyurethane and In 14 of the cases the type of coverage is unknown.
Protocol for the study
In February 2019the Advisory Commission on Breast and Related Implants, together with experts in medical oncology and in hematology and hemotherapy, developed a protocol for detection and study These days it has just been updated taking into account the latest publications and advances regarding this disease.
The objectives of this clinical protocolthe Agency explains, are: detecting cases, establishing the steps to be followed by the health professional in the case of suspicion for correct diagnosis and identification and subsequent treatment, and gathering information that allows evaluating a possible association between this disease and the implantation of prostheses.
As established in national legislationhealth workers have the obligation to communicate serious incidents related to medical products of which they are aware, such as the case of ALCL associated with breast implants. Thus, of the 70 notifications by professionals, 63 cases have been confirmed.
The manufacturer It also has the obligation to notify the AEMPS of serious incidents that occur with its products and the results of their investigation. Of the 53 incidents that were reported, 27 cases were subsequently confirmed and 9 of these notifications corresponded to bibliographic cases.