Smooth or Textured: A Lesson in Biocompatibility
The objective of the textured surface is to limit movement and reduce the formation of overly tight scar tissue. It is noteworthy here that the function of the textured surface depends on its ability to alter tissue response. Yet this can lead to inconsistent thinking in which positive effects of surface changes are touted while negative effects are denied.
Unfortunately, textured surfaces on breast implants have also been linked to the development of Anaplastic Large Cell Lymphoma (ALCL), an adverse effect beyond any associated just with the long-term presence of silicone. FDA has noted that factors influencing ALCL inclu...
Source: MDDI - April 17, 2019 Category: Medical Devices Authors: William A. Hyman Tags: Materials Source Type: news
Purified Fat Could Be an Alternative to Breast Implants
There has been intense discussion lately about the risks associated with breast implants. France has gone so far as to ban the use of textured breast implants – an act that occurred earlier this month.
Solana Beach, CA-based Puregraft has developed an option other than an implant - a technology that would use a patient’s own fat, for breast augmentation, or restructuring.
“Fat transfer, believe it or not, is the most popular procedure that you’ve never heard of,†Brad Conlan, Puregraft CEO, told MD+DI. “The first fat...
Source: MDDI - April 12, 2019 Category: Medical Devices Authors: Omar Ford Tags: Business Source Type: news
Mother, 28, reveals she nearly died after TWO botched breast implants advertised on Instagram
Holly McCulloch, 28, of Greasby, Wirral, always felt down about her B-cup chest, particularly as she got older. She therefore booked herself into a clinic that charged £2,700 for a five-day, all-inclusive stay. (Source: the Mail online | Health)
Source: the Mail online | Health - April 11, 2019 Category: Consumer Health News Source Type: news
Australia ’s TGA considering, but not yet implementing, textured breast implant ban
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 and ...
Source: Mass Device - April 10, 2019 Category: Medical Devices Authors: Fink Densford Tags: Cosmetic/Aesthetic Oncology Regulatory/Compliance Women's Health Source Type: news
France Bans Textured Breast Implants
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 - April 8, 2019 Category: Medical Devices Authors: Amanda Pedersen Tags: Implants Regulatory and Compliance Source Type: news
Health Canada Plans to Suspend Allergan's Breast Implant License Health Canada Plans to Suspend Allergan's Breast Implant License
Health Canada said on Thursday it was advising Allergan Plc of the regulator ' s plans to suspend the license for the Botox-maker ' s Biocell breast implants, after a review regarding the risk of a rare cancer linked to breast implants.Reuters Health Information (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - April 5, 2019 Category: Consumer Health News Tags: Hematology-Oncology News Source Type: news
Health Canada notifies Allergan on intent to suspend Biocell breast implant license
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 BIA-ALCL, add...
Source: Mass Device - April 5, 2019 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Cosmetic/Aesthetic Regulatory/Compliance Women's Health Allergan Source Type: news
Report: France to ban textured breast implants
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 individuals with b...
Source: Mass Device - April 5, 2019 Category: Medical Devices Authors: Fink Densford Tags: Cosmetic/Aesthetic Featured Regulatory/Compliance Women's Health Source Type: news
France Is First to Ban Breast Implants Linked to Rare Cancer
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)
Source: NYT Health - April 5, 2019 Category: Consumer Health News Authors: CONSTANT MEHEUT Tags: Implants Breasts Plastic Surgery Accidents and Safety Allergan Inc France anaplastic large-cell lymphoma Source Type: news
Biocell textured breast implants could soon be pulled from the market: Health Canada
Sales of Biocell textured breast implants, which had been flagged for safety issues in a CBC News investigation, could soon be suspended, Health Canada says. (Source: CBC | Health)
Source: CBC | Health - April 4, 2019 Category: Consumer Health News Tags: News/Health Source Type: news
FDA Eyes Tailored Approach to Regulating AI-Based Medical Devices
FDA Commissioner Scott Gottlieb is making the most of his final week at the agency.
In the month that has passed since Gottlieb rattled the medical device industry with news of his impending resignation, the commissioner has issued 18 public statements pertaining to nearly all corners of the agency's realm, from food, tobacco, and cosmetics to drugs and devices. Friday is Gottlieb's last day on the job.
On Tuesday, Gottlieb said the agency will consider a new regulatory framework for reviewing medical devices that use advanced artificial intelligence algorithms. AI has been making headlines in medtech for a whi...
Source: MDDI - April 3, 2019 Category: Medical Devices Authors: Amanda Pedersen Tags: Regulatory and Compliance Software Source Type: news
Mother, 29, claims her breast implants almost KILLED her
Gabrielle Case, of North Carolina, was fit and healthy until a year after having implants in 2015. She ended up bed-bound and struggling to breathe by December 2018. (Source: the Mail online | Health)
Source: the Mail online | Health - April 2, 2019 Category: Consumer Health News Source Type: news
More Info on Risks of Breast Implants Needed, Says FDA Panel More Info on Risks of Breast Implants Needed, Says FDA Panel
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)
Source: Medscape Hematology-Oncology Headlines - March 27, 2019 Category: Cancer & Oncology Tags: Hematology-Oncology News Source Type: news
Women raise concerns about breast implant safety
Panel members in a two-day public hearing held by the US Food and Drug Administration this week agreed that efforts should be made to better inform patients about the risks and benefits of breast implants. (Source: CNN.com - Health)
Source: CNN.com - Health - March 26, 2019 Category: Consumer Health News Source Type: news
Women need better information on breast implants, panel says
Members of a Food and Drug Administration advisory committee scrutinizing the safety of breast implants urged the agency on Tuesday to take steps to ensure that patients have a clearer understanding o... (Source: Washington Post: To Your Health)
Source: Washington Post: To Your Health - March 26, 2019 Category: Consumer Health News Authors: Laurie McGinley Source Type: news
