The agency also announces the qualification of a tool for development of medical devices to help in the evaluation of efficiency of the devices used in breast reconstruction
Today, the Food and Drug Administration of the USA (FDA, for its acronym in English) is providing an update on the adverse events that have been reported to the Agency associated with breast implants, including anaplastic large cell lymphoma associated with breast implants (BIA-ALCL), and the signs and symptoms of systemic patients call disease of the breast implant (BII, for its acronym in English), some patients report after receiving breast implants. The FDA is also evaluating the Module of Reconstruction BREAST-Q as a tool for development of medical devices (MDDT, for its acronym in English) to assist in the evaluation of certain devices such as breast implants. The qualification of the Module of Reconstruction BREAST-Q included the dimensions of physical well-being (chest), psychosocial well-being, sexual well-being and Satisfaction with breasts. A MDDT is validated scientifically, and you can be qualified for use in the evaluation of devices and to support decision making by regulatory. Examples of MDDT are assessments of clinical outcomes, assessments of biological markers, and the methods or models of assessment non-clinical. The use of a MDDT qualified by the sponsor of a product is voluntary.
“The FDA has been monitored diligently adverse events associated with breast implants for decades and has been working to better understand the quality of life and satisfaction that a patient of breast reconstruction can experience to be able to refine our assessment of the benefits and risks of breast implants. Our qualification Module Reconstruction BREAST-Q as a validated tool to assess the results of surgery for breast reconstruction in terms of quality of life and satisfaction help to achieve this,” said Dr. Binita Ashar, director of the Office of Surgical Devices and Infection Control in the Center for Devices and Radiological Health. “In addition, we continued to increase our scientific knowledge with regard to the BIA-ALCL and systemic symptoms known as BII, and we remain committed to keeping the public informed.”
Reports of medical devices on BIA-ALCL
The analysis of the FDA's report global medical devices on BIA-ALCL covers the reports received up to January 5, 2020. Updated to the latest report made public by the FDA with new information on 7 July 2019 to 5 January 2020. Today, the FDA updated the box on the web site (in English) of BIA-ALCL of the agency to include a total of 733 unique cases and 36 deaths of patients at the global level, which reflects an increase of 160 new cases and 3 deaths from the update from the beginning of July 2019.
Specifically, a total of 733 unique cases of BIA-ALCL reported to the FDA, 620 cases were reported for implants, Allergan, and 47 cases involving implants with an unknown manufacturer. With respect to the surface of the implant of the 733 unique cases of BIA-ALCL, 496 cases were reported to have textured implants, and 209 cases did not specify the surface of the implant. Of the total of 36 deaths of patients reported to the FDA, 15 of the 16 patients with implants manufactured by a well-known manufacturer, were reported to have an implant that Allergan at the time they received their diagnosis of BIA-ALCL. In terms of the surface of the implant, between the 36 reported cases of deaths of patients, 16 cases were reported to have textured implants, and 19 cases did not specify the surface of the implant.
BIA-ALCL is not breast cancer; it is a type of non-hodgkin 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. At this time, the overall impact of developing BIA-ALCL is low; however, a diagnosis of BIA-ALCL is serious and can result in death, especially if not diagnosed and treated early. In the majority of patients, BIA-ALCL is treated successfully with surgery to remove the implant and the scar tissue surrounding the implant; however, some patients may require treatment with chemotherapy and/or radiation therapy.
Reports of medical devices of the systemic symptoms called BII
In addition to the update on BIA-ALCL, the FDA is updating the data in reports of medical devices received with respect to the signs and symptoms of systemic patients call BII. A new painting in the FDA's web site summarizes the report's unique medical devices BII of the U.S. and around the world that the FDA has received between 1 January 2008 and 31 October 2019. The data show that the FDA has received 2,497 reports of medical devices that included symptoms consistent with BII from November 2018 to October 2019. The data of the FDA from January 2008 to October 2018 showed 1,080 reports that included these symptoms. More patients and providers are reporting these conditions, likely due to the increase in awareness on the part of the press, social media, and the meeting (in English) of the Consultative Committee of devices, plastic surgery and general of the FDA, which took place in march of 2019.
Although there is limited use for the term “disease of the breast implant” in the medical literature, the symptoms such as tiredness, memory loss, skin rash, confusion, and pain in the joints may be associated with breast implants, and some patients and doctors use the term “disease of the breast implant” to describe these symptoms, or used this term to report them to the FDA. The 10 most common symptoms reported to the database of reports of medical devices the FDA for patients with breast implants include fatigue (49 percent), confusion (25 percent), joint pain (25 percent), anxiety (24%), hair loss (21 percent), depression (19%), rash (18%), autoimmune diseases (18 percent), inflammation (18 percent) and/or weight issues (18 percent). Researchers are studying these symptoms to better understand their origins and their connection to breast implants.
Although the FDA doesn't have definitive evidence demonstrating breast implants cause these symptoms, the current evidence supports that some patients experience systemic symptoms that may vanish altogether when to remove breast implants. The FDA is committed to sharing the information the agency receives on the systemic symptoms reported by patients with breast implants.
Qualification of the Module of Reconstruction BREAST-Q as a tool for development of medical devices
The FDA also announced today (in English) the qualification of a validated questionnaire that is self-managed, the Module of Reconstruction BREAST-Q (in English) by using the program MDDT of the agency.
The versions in paper and electronic self-administered in the dimensions of physical well-being (chest), psychosocial well-being, sexual well-being and Satisfaction with the breast Module of Reconstruction BREAST-Q was used to quantify the different aspects of quality of life and satisfaction with breast reconstruction surgery of a woman. These dimensions can be used by the sponsors of medical devices and sponsors-researchers in feasibility studies, central-and post-approval to support the effectiveness of medical devices in the breast reconstruction, such as an implant or fabric, appropriate for clinical importance of the dimension to support the proposed indication.
The FDA remains committed to dialogue, thoughtful, scientific and transparent with the public with respect to the safety and effectiveness of breast implants. The health care professionals and consumers should report any adverse event related to the breast implants to the Program notification of adverse events (in English) of the FDA. The FDA monitors these reports and takes appropriate action necessary to help ensure the safety of products provider in the market.
Finally, today the FDA released a video about seven things that patients should know about breast implants, including the risks, complications, and information about BIA-ALCL and systemic symptoms.
The FDA will continue to analyze all the information available about the risks associated with breast implants, updating usually the analysis of BIA-ALCL and BII published on our website, and taking additional measures where and when necessary.
The FDA, an agency that is part of the Department of Health and Human Services of the united States, protects the public health by assuring the safety, effectiveness and protection of human and veterinary medicinal products, vaccines and other biological products for human use, and medical devices. The agency is also responsible for the safety of the food supply, cosmetics, dietary supplements, and products that emit radiation electronics of our nation, and for regulating tobacco products.
The agency also announces the qualification of a medical device development tool to assist in the evaluation of the efficacy of devices used in breast reconstruction.
Today, the U.S. Food and Drug Administration (FDA) is providing an update on adverse events that have been reported to the Agency related to breast implants, including breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), and systemic signs and symptoms called breast implant illness (BII), which some patients report after receiving breast implants. The FDA is also qualifying the BREAST-Q Reconstruction Module as a medical device development tool (MDDT) to aid in the evaluation of certain devices such as breast implants. The BREAST-Q Reconstruction Module qualification included the dimensions of Physical Well-Being (Breast), Psychosocial Well-Being, Sexual Well-Being, and Breast Satisfaction. A MDDT is scientifically validated and may be qualified for use in device evaluation and to support regulatory decision-making. Examples of MDDTs include clinical outcome assessments, biological marker assessments, and nonclinical evaluation methods or models. Use of a qualified MDDT by a product sponsor is voluntary.
“The FDA has been diligently monitoring adverse events associated with breast implants for decades and has been working to better understand the quality of life and satisfaction a breast reconstruction patient may experience so we can refine our assessment of the benefits and risks of breast implants. Our qualification of the BREAST-Q Reconstruction Module as a validated tool to assess breast reconstruction surgery outcomes in terms of quality of life and satisfaction helps accomplish this,” said Binita Ashar, MD, director of the Office of Surgical Devices and Infection Control in the Center for Devices and Radiological Health. “In addition, we continue to increase our scientific knowledge regarding BIA-ALCL and the systemic symptoms known as BII, and we remain committed to keeping the public informed.”
Medical Device Reports on BIA-ALCL
FDA’s analysis of global medical device reports on BIA-ALCL covers reports received through January 5, 2020. It updates FDA’s last publicly available report with new information from July 7, 2019, to January 5, 2020. Today, FDA updated the table on the agency’s BIA-ALCL website to include a total of 733 unique cases and 36 patient deaths globally, reflecting an increase of 160 new cases and 3 deaths since the early July 2019 update.
Specifically, of the 733 total unique cases of BIA-ALCL reported to the FDA, 620 cases were reported for Allergan implants, and 47 cases involved implants from an unknown manufacturer. Regarding implant surface of the 733 unique cases of BIA-ALCL, 496 cases reported having textured implants, and 209 cases did not specify the implant surface. Of the 36 total patient deaths reported to the FDA, 15 of the 16 patients with implants manufactured by a known manufacturer reported having an Allergan implant at the time they received their BIA-ALCL diagnosis. Regarding implant surface, among the 36 reported cases of patient deaths, 16 cases reported having textured implants, and 19 cases did not specify the implant surface.
BIA-ALCL is not breast cancer; it is a type of non-Hodgkin 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. At this time, the overall incidence of developing BIA-ALCL is low; however, a diagnosis of BIA-ALCL is serious and can result in death, especially if it is not diagnosed or treated early. In most patients, BIA-ALCL is successfully treated with surgery to remove the implant and scar tissue surrounding the implant; however, some patients may require treatment with chemotherapy and/or radiation therapy.
Medical device reports of systemic symptoms called BII
In addition to the update on BIA-ALCL, the FDA is updating data on medical device reports received regarding systemic signs and symptoms that patients call BII. A new chart on the FDA website summarizes unique U.S. and global medical device BII reports that the FDA has received between January 1, 2008, and October 31, 2019. The data shows that the FDA received 2,497 medical device reports that included symptoms consistent with BII from November 2018 through October 2019. FDA data from January 2008 through October 2018 showed 1,080 reports that included these symptoms. More patients and providers are reporting these conditions, likely due to increased awareness from the press, social media, and the FDA General and Plastic Surgery Devices Advisory Committee meeting held in March 2019.
Although there is limited use of the term “breast implant illness” in the medical literature, symptoms such as fatigue, memory loss, rash, confusion, and joint pain can be associated with breast implants, and some patients and physicians use the term “breast implant illness” to describe these symptoms or use this term when reporting them to the FDA. The 10 most common symptoms reported to the FDA’s medical device reporting database from patients with breast implants include fatigue (49 percent), confusion (25 percent), joint pain (25 percent), anxiety (24 percent), hair loss (21 percent), depression (19 percent), rash (18 percent), autoimmune disease (18 percent), inflammation (18 percent), and/or weight problems (18 percent). Researchers are studying these symptoms to better understand their origins and connection to breast implants.
Although the FDA does not have definitive evidence showing that breast implants cause these symptoms, current evidence supports that some patients experience systemic symptoms that may resolve when breast implants are removed. The FDA is committed to sharing information the agency receives about systemic symptoms reported by patients with breast implants.
Qualification of the BREAST-Q Reconstruction Module as a Medical Device Development Tool
The FDA also announced today the qualification of a validated, self-administered questionnaire, the BREAST-Q Reconstruction Module , through the agency’s MDDT program.
The self-administered paper and electronic versions of the Physical Well-Being (Breast), Psychosocial Well-Being, Sexual Well-Being, and Breast Satisfaction dimensions of the BREAST-Q Reconstruction Module are used to quantify different aspects of a woman’s quality of life and satisfaction with breast reconstruction surgery. These dimensions may be used by medical device sponsors and sponsor-investigators in feasibility, core, and post-approval studies to support the efficacy of medical devices in breast reconstruction, such as an implant or fabric, appropriate to the clinical importance of the dimension to support the proposed indication.
The FDA remains committed to a thoughtful, scientific, and transparent dialogue with the public regarding the safety and effectiveness of breast implants. Health care professionals and consumers should report any adverse events related to breast implants to the FDA’s Adverse Event Reporting Program . The FDA monitors these reports and takes appropriate action as necessary to help ensure the safety of medical products on the market.
Finally, today the FDA released a video on seven things patients should know about breast implants, including risks, complications, and information about BIA-ALCL and systemic symptoms.
The FDA will continue to review all available information on the risks associated with breast implants, regularly update the BIA-ALCL and BII analyses posted on our website, and take additional actions when and where appropriate.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency is also responsible for the security of our nation’s food supply, cosmetics, dietary supplements, and products that emit electronic radiation, and for regulating tobacco products.
Escrito por FDA News Release | Revisado por Gloria Sánchez Contreras
August 20, 2020
Original Source: https://www.fda.gov/news-events/press-announcements/la-fda-actualiza-analisis-de-informes-de-dispositivos-medicos-sobre-la-enfermedad-del-implante
