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Search Results for '
breast implant
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GC Aesthetics Gains EU Nod for LUNA xt Breast Implant, First Under MDR
The new product is a response to surgeon and patient needs in breast reconstructive procedures.
Sam Brusco, Associate Editor
10.04.22
New Breast Implant Surgery Guidelines to Enhance Patient Safety
Australian doctors must now follow certain standards of care during the procedure and afterwards.
Michael Barbella, Managing Editor
05.27.22
Surgical
FDA Approves J&J's MENTOR MemoryGel BOOST Breast Implant
Implant provides natural feel patients desire with increased form stability.
Sam Brusco, Associate Editor
01.13.22
Surgical
FDA Strengthens Breast Implant Safety Requirements, Updates Study Results
Agency adds restrictions and approves new labeling for all approved breast implants.
U.S. Food and Drug Administration
10.27.21
Surgical
FDA Issues Warning Letters to Two Breast Implant Makers
Allergan and Ideal Implant Inc. failed to comply with various regulatory requirements.
U.S. Food and Drug Administration
05.15.20
Materials
|
Surgical
Evonik and BellaSeno Partner on 3D Printed Breast Implants
Technology designed to improve quality of life for patients after breast reconstruction and augmentation.
PR Newswire
11.13.19
Surgical
FDA Releases Draft Guidance to Enhance Breast Implant Safety Information
FDA recommends including a boxed warning and other elements in breast implant labeling.
U.S. Food and Drug Administration
10.28.19
Allergan Recalls BIOCELL Textured Breast Implants and Tissue Expanders
The global action follows the notification of updated safety information from the FDA.
PR Newswire
07.24.19
Surgical
FDA Offers Update on Efforts to Ensure Breast Implant Safety
FDA hopes to ensure that women have the most complete information available to make important breast implant decisions.
Amy Abernethy, M.D., Ph.D., FDA Principal Deputy Commissioner; Jeff Shuren, M.D., J.D., CDRH Director
05.06.19
Surgical
FDA Warns J&J and Sientra for Breast Implant Compliance Failure
The two breast implant manufacturers failed to comply with post-approval study requirements.
U.S. Food and Drug Administration
03.20.19
Surgical
FDA's Update on Efforts to Educate Patients on Known Breast Implant Lymphoma Risk
As of September 2018, the agency has received a total of 660 total medical device reports regarding lymphoma cases.
U.S. Food and Drug Administration
02.11.19
Surgical
Lawsuit Alleges J&J Breast Implants Caused Lymphoma in Ohio Woman
Renee Cashen had surgery to remove J&J subsidiary Mentor Worldwide's MemoryGel SILTEX implants, and six infected lymph nodes.
PR Newswire
05.01.18
Ten-Year Clinical Study Data Highlight Safety of MENTOR MemoryShape Gel Breast Implants
Latest data show product safety and effectiveness in primary and revision augmentation and reconstruction patients.
Johnson & Johnson
03.12.18
Surgical
New Breast Implant for Patients Undergoing Breast Reconstruction, Augmentation, or Revision Surgery
MENTOR announces U.S. availability for MemoryGel Xtra Breast Implants.
PR Newswire
10.05.17
Electronics
|
R&D & Design
VeriTeQ Partner Receives Additional CE Mark Approvals to Market Breast Implants
Approvals permit sale of Motiva implants with safety technology to 28 countries.
05.12.14
Materials
|
Testing
AMSilk Advances Silicone Breast Implant Coating
Company publishes preclinical trial results of silicone implants made with recombinant spider silk.
04.10.14
R&D & Design
New Breast Implant Passes Muster at FDA
Allergan will be required to perform long-term post-op studies to ensure safety.
Niki Arrowsmith
02.27.13
J & J to Acquire Breast Implant Company
Deal worth $1.1 billion
Editor
12.08.08
J & J to Acquire Breast Implant Company
Deal worth $1.1 billion
Editor
12.08.08
Ban on Silicone Breast Implants Lifted
...
Ed Kensik
11.17.06
Ban on Silicone Breast Implants Lifted
...
Ed Kensik
11.17.06
Breaking News
MPO's Most-Read Stories This Week—April 20
Afon Technology Wins Junkosha Technology Innovator of the Year Award
Portal Enables Public to Report Anticompetitive Practices in Healthcare
FDA OKs Lowering Age for Osia Cochlear Implant to 5 Years Old
Clinical Consultants to Provide Regulatory, Development Help to Futura Surgicare
View Breaking News >
CURRENT ISSUE
April 2024
Medical Tubing & Extrusion Experts Offer Perspectives on Industry
Creating Sustainable Surfaces in Med Device Coating and Finishing
Man & Machine: Artificial Intelligence's Impact on Medtech
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