Safety review of breast implants re-opened after Implant Files stories

Health Canada is re-opening its safety review of breast implants after more Canadian women were identified with symptoms of a rare cancer. The department has received reports of 22 confirmed cases and another 22 suspected cases of breast implant-associated anaplastic large cell lymphoma.
Source: CBC | Health - Category: Consumer Health News Tags: News/Health Source Type: news

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Conclusions Epidemiological studies have repeatedly helped identify definitive triggers for several diseases. As highlighted in this perspective report, previous studies strongly argue for the interplay between intrinsic factors and putative preventable extrinsic triggers/promoters for CTCL. Given the evidence of geographical regional clustering of CTCL patients, CTCL occurrence in unrelated family members and recent evidence implicating S. aureus in the pathogenesis/progression of CTCL, more research is needed to decipher the precise mechanism by which specific environmental exposures may be driving the pathogenesis of t...
Source: Frontiers in Oncology - Category: Cancer & Oncology Source Type: research
Australia’s TGA said yesterday that it is seeking new data from suppliers of textured breast implants, which have been linked to a rare immune-system cancer, before making a decision on whether or not to suspend or cancel those products from its Register of Therapeutic Goods. The regulatory body gave suppliers of the devices 10 working days to respond to the requests for more information, including dates they began to supply the devices and samples of the implants, according to a TGA release. The decision comes after the convening of a breast implant expert panel on April 8, following recent decisions made in Canada ...
Source: Mass Device - Category: Medical Devices Authors: Tags: Cosmetic/Aesthetic Oncology Regulatory/Compliance Women's Health Source Type: news
France has banned several types of textured breast implants that have been linked to a rare form of cancer, and more countries appear to be following suit, including Canada and the Netherlands. For years researchers have raised concern about the potential association between breast implants and anaplastic large cell lymphoma (ALCL), a very rare form of cancer, but France is the first country to ban the devices. The ban took effect on Friday and covers macro-textured implants and implants with a polyurethane coating. The National Agency for Safety of Medicines and Health Products (ANSM) in France notified manufa...
Source: MDDI - Category: Medical Devices Authors: Tags: Implants Regulatory and Compliance Source Type: news
AbstractImplant-associated breast cancer is a well-described pathologic process that occurs in patients with breast implants. Anaplastic large cell lymphoma (ALCL), the most prominent malignancy associated with breast implants, has been extensively described, while literature regarding non-ALCL implant-associated cancers is limited. Here, we present a rare case of a 55-year-old female with squamous cell carcinoma (SCC) of the breast and chest following multiple breast revision surgeries who underwent tumor resection with a unique soft tissue reconstruction utilizing two anterolateral thigh (ALT) flaps in a flow-through manner.
Source: European Journal of Plastic Surgery - Category: Cosmetic Surgery Source Type: research
Health Canada said yesterday that it plans to suspend Allergan‘s (NYSE: AGN) licenses to sell its Biocell breast implants in the region due to a possible association with a rare immune system-cancer. The move follows the agency’s completion of a scientific assessment of macro-textured implants, which it said is part of a larger safety review of breast implants and their association with breast implant-associated anapestic large cell lymphoma (BIA-ALCL), a type of non-Hodgkin’s lymphoma. Health Canada said it launched the review last November due to an increase in Canadian and international cases of B...
Source: Mass Device - Category: Medical Devices Authors: Tags: Business/Financial News Cosmetic/Aesthetic Regulatory/Compliance Women's Health Allergan Source Type: news
France is planning to ban textured breast implants, which have been linked a rare immune-system cancer, according to a report from France24. France’s National Agency for Medicines and Health Products began informing manufacturers on April 2 of its plans to ban manufacturing, distribution, importing, exporting, promotion and wearing of textured breast implants and polyurethane breast implants, according to the report. The soon-to-be-banned implants have been linked to breast implant-associated anapestic large cell lymphoma (BIA-ALCL), a type of non-Hodgkin’s lymphoma. France’s ANSM has been tracking indivi...
Source: Mass Device - Category: Medical Devices Authors: Tags: Cosmetic/Aesthetic Featured Regulatory/Compliance Women's Health Source Type: news
The ban covers textured breast implants, which are suspected of being linked to anaplastic large-cell lymphoma. Regulators in other countries are following suit.
Source: NYT Health - Category: Consumer Health News Authors: Tags: Implants Breasts Plastic Surgery Accidents and Safety Allergan Inc France anaplastic large-cell lymphoma Source Type: news
A 2-day meeting highlighted the risk for a rare lymphoma, described as a'man-made cancer,'and heard calls for a ban on certain products, but advisers also highlighted lack of data.Medscape Medical News
Source: Medscape Hematology-Oncology Headlines - Category: Cancer & Oncology Tags: Hematology-Oncology News Source Type: news
A panel of experts convened by the FDA yesterday said that there’s not enough data to pull textured breast implants from the market over concerns that they may be linked to a type of immune system cancer, according to an AP News report. The recommendation comes from the first day of a two-day panel meeting discussing the risks associated with breast implant devices, reviewing current study data and exploring how to best track and treat the cancer, and other issues, the devices have been tied to. The FDA only began reporting on the cancer, known as breast implant-associated anaplastic large cell lymphoma, and its link...
Source: Mass Device - Category: Medical Devices Authors: Tags: Cosmetic/Aesthetic Food & Drug Administration (FDA) Oncology Women's Health Source Type: news
(CNN) — Many women have breast implants with no serious complications, but there have been cases where women suffer pain and fatigue, among other health problems. Now, the US Food and Drug Administration plans to hold a meeting to take a closer look at such cases and put breast implant safety under a microscope. The FDA will convene a meeting of the Medical Devices Advisory Committee’s General and Plastic Surgery Devices Panel on Monday and Tuesday to discuss and make recommendations relating to the risks and benefits of breast implants. The meeting, which will be open to the public, comes just days after the F...
Source: WBZ-TV - Breaking News, Weather and Sports for Boston, Worcester and New Hampshire - Category: Consumer Health News Authors: Tags: Health News CNN Source Type: news
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