Deep Blue Medical Advances Announces FDA Clearance and U.S. Clinical Launch of the T-Line Hernia Mesh
DURHAM, N.C., Aug. 11, 2020 -- (Healthcare Sales & Marketing Network) -- Deep Blue Medical Advances today announced it has received 510(k) Clearance from the U.S. Food and Drug Administration (FDA) for its T-Lin® Hernia Mesh with integrated suture-lik... Devices, Surgery, FDA, Product Launch Deep Blue Medical Advances, T-Line, Hernia Mesh, hernia (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - August 11, 2020 Category: Pharmaceuticals Source Type: news
Hernia mesh implants used 'with no clinical evidence'
The devices cut into tissue and nerves, leaving some unable to walk, work or care for their children. (Source: BBC News | Health | UK Edition)
Source: BBC News | Health | UK Edition - January 15, 2020 Category: Consumer Health News Source Type: news
Exogenesis Corporation Announces the Filing of a 510(k) Pre-Marketing Notification Application with the US Food and Drug Administration for Exogenesis Hernia Mesh
Exogenesis Hernia Mesh is the First Soft Tissue Repair Device with Nano-Modified Surface BILLERICA, Mass., July 24, 2019 -- (Healthcare Sales & Marketing Network) -- Exogenesis Corporation announced today that it has successfully completed filing of a ... Devices, Surgery, FDA Exogenesis, Hernia Mesh, Accelerated Neutral Atom Beam (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - July 24, 2019 Category: Pharmaceuticals Source Type: news
FDA Flips the Switch on Pelvic Mesh Manufacturers
After years of controversy surrounding the use of surgical mesh for transvaginal repair of pelvic organ prolapse (POP), FDA has ordered Boston Scientific and Coloplast to stop selling the mesh on the U.S. market immediately. The agency said the manufacturers have not demonstrated a reasonable assurance of safety and effectiveness for these devices, which is the premarket review standard that now applies to them since FDA decided they were high risk in 2016. âIn order for these mesh devices to stay on the market, we determined that we needed evidence that they worked better than surgery without the use of ...
Source: MDDI - April 17, 2019 Category: Medical Devices Authors: Amanda Pedersen Tags: Regulatory and Compliance Source Type: news
Hernia mesh complications affect up to 170,000 people in England
Between 12 and 30 per cent of the 570,000 people who have had the procedure over the past six years in England are left in such severe pain they are unable to walk or work. (Source: the Mail online | Health)
Source: the Mail online | Health - September 26, 2018 Category: Consumer Health News Source Type: news
Hernia mesh complications 'affect more than 100,000'
Jen Coles had to use a cane to walk following her mesh implant, which left her in chronic pain. (Source: BBC News | Health | UK Edition)
Source: BBC News | Health | UK Edition - September 26, 2018 Category: Consumer Health News Source Type: news
Hernia Mesh Labels Lack Key Info: General Surgery News Report
(MedPage Today) -- Also, ways to reduce gun violence (Source: MedPage Today Public Health)
Source: MedPage Today Public Health - April 19, 2018 Category: American Health Source Type: news
BD ’ s C.R. Bard must pay $4m in IVC bellwether
Becton Dickinson & Co.’s (NYSE:BDX) C.R. Bard (NYSE:BCR) is on the hook for $3.6 million in damages after a federal jury in Phoenix found Bard liable for damages caused by inferior vena cava filtering devices. The case is the first bellwether trial out of more than 3,000 suits which have been filed against Bard related to IVC filters. In the case, plaintiff Sherr-Una Booker claimed that the device, intended to prevent pulmonary emboli, broke apart during use, leaving pieces lodged in her cardiovascular system causing serious damage. Awarded damages include $2 million in compensatory damages and nearly $...
Source: Mass Device - April 3, 2018 Category: Medical Devices Authors: Fink Densford Tags: Blood Management Legal News Neurological bectondickinson crbard Source Type: news
BD Scores a Victory in Bard & #039;s Hernia Mesh Case
Becton Dickinson, which acquired C.R. Bard at the end of 2017, scored a victory in New Jersey Superior Court this week. The court's appellate division refused to reinstate a product liability lawsuit involving Bard's 3DMax polypropylene mesh, which is used for hernia repair. Plaintiff Kemuel Goodson was implanted with the product in 2006 and alleged that the mesh caused multiple complications that required extensive medical care, including several additional operations. Goodson claimed in his original complaint that defective design, negligence, and fraud and misrepresentation were to blame for the com...
Source: MDDI - March 21, 2018 Category: Medical Devices Authors: Amanda Pedersen Tags: Business Design Source Type: news
Bard wins 3DMax hernia mesh appeal
The New Jersey Superior Court’s Appellate Division this week tossed a win to Becton Dickinson & Co.‘s (NYSE:BDX) C.R. Bard (NYSE:BCR), refusing to reinstate a hernia mesh product liability suit on grounds that expert witnesses couldn’t prove the design of the product was defective or that significant negligence occurred. In the case, plaintiff Kemuel Goodson claims that implantation of Bard’s 3DMax polypropylene mesh during a laparoscopic bilateral inguinal hernia repair in 2006 caused a number of different complications, including remaining pain and the removal of a testicle, and requ...
Source: Mass Device - March 20, 2018 Category: Medical Devices Authors: Fink Densford Tags: Legal News Surgical bectondickinson crbard Source Type: news
Bard escapes hernia mesh lawsuit
Becton Dickinson & Co.‘s (NYSE:BDX) C.R. Bard (NYSE:BCR) and subsidiary Davol this week avoided a lawsuit over allegedly defective hernia meshes after an appellate panel reaffirmed a lower court’s dismissal. The lower court had dismissed the suit on the grounds that the operating physician in the case was informed of risks associated with the mesh, eliminating the plaintiff’s argument that the company did not appropriately warn physicians on the issue. The decision came from the US Court of Appeals for the Eleventh Circuit on Wednesday, with Judges Marcus, Anderson and Hull finding in their revie...
Source: Mass Device - February 9, 2018 Category: Medical Devices Authors: Fink Densford Tags: Legal News Surgical bectondickinson crbard Davol Inc. Source Type: news
Hernia mesh surgery leaves men in pain
A group of NI men say they have been left in chronic pain after having mesh inserted for hernias. (Source: BBC News | Health | UK Edition)
Source: BBC News | Health | UK Edition - September 20, 2017 Category: Consumer Health News Source Type: news
NHS hernia mesh repairs could leave thousands in agony
NHS England said mesh implants are the 'recommended method' for treating a hernia, which occurs when an organ or fatty tissue protrudes through an area of weak muscle in the body. (Source: the Mail online | Health)
Source: the Mail online | Health - June 26, 2017 Category: Consumer Health News Source Type: news
NHS hernia mesh repairs 'leaving patients in chronic pain'
The mesh left one woman "screaming on all fours from the agonising pain". (Source: BBC News | Health | UK Edition)
Source: BBC News | Health | UK Edition - June 26, 2017 Category: Consumer Health News Source Type: news
NHS hernia mesh felt like 'scratching from inside'
Surgeons have warned the repair technique is leaving many patients in chronic pain. (Source: BBC News | Health | UK Edition)
Source: BBC News | Health | UK Edition - June 26, 2017 Category: Consumer Health News Source Type: news
Best of 2016: The 10 most-read stories of the year
Each year, the editor’s of MassDevice write roughly 2,500 stories about the medical technology industry. These articles touch on the wins, the losses, the extraordinary and, sometimes, mundane machinations of this incredible industry. Our most popular stories this year hit some of the industry’s hot-button issues, including the M&A blockbuster of the year, Abbott’s $25 billion buyout of St. Jude Medical; Johnson & Johnson’s plan to slash 3,000 jobs from its medtech division; Google- and J&J-backed Verb Surgical’s play in robot-assisted surgery; and the global mockery around the reb...
Source: Mass Device - December 15, 2016 Category: Medical Equipment Authors: MassDevice Tags: News Well Source Type: news
Dongguan Kewei's Polypropylene Hernia Mesh Granted CFDA Approval
(Source: Microport News Release)
Source: Microport News Release - July 11, 2016 Category: Medical Equipment Source Type: news
J&J’s Ethicon recalls Physiomesh flexible composite hernia mesh
Johnson & Johnson (NYSE:JNJ) subsidiary Ethicon last month recalled 1 of its surgical mesh products after studies showed higher revision rates after a type of minimally invasive hernia repair using its Physiomesh flexible composite mesh. In a May 25 letter to healthcare providers, Ethicon said it’s pulling the mesh after a review of unpublished data from a pair of European registries revealed the discrepancy between Physiomesh flexible composite and the other meshes in the registries after laparoscopic ventral hernia repair. West Somerville, N.J.-based Ethicon said it believes the higher revision rates ...
Source: Mass Device - June 20, 2016 Category: Medical Equipment Authors: Brad Perriello Tags: Recalls Surgical Ethicon Johnson & Johnson Source Type: news
Via Surgical raises $6m for FasTouch hernia suture
Via Surgical said today that it raised a $6 million funding round for its FasTouch hernia suture. Benslie Investment Group led the round, with managing partner Nicolas Weinstein joining Amirim, Israel-based Via Surgical’s board. “The addition of Benslie Investment Group to our highly experienced team validates the opportunity to advance patient care with the FasTouch deployable suture fixation system. Their investment will greatly support the increasing clinical demand for improved fixation through our development and commercialization efforts in 2016,” co-founder & CFO Lena Levin ...
Source: Mass Device - February 8, 2016 Category: Medical Equipment Authors: Brad Perriello Tags: Funding Roundup Surgical Via Surgical Source Type: news
Ariste Medical Receives $4.6MM Investment to Support Development of Drug-Eluting Hernia Mesh
MEMPHIS, Tenn.--(Healthcare Sales & Marketing Network)--Ariste Medical, a pre-commercial drug-device company, today announced a $4.6MM investment for continued development of a drug-eluting hernia mesh intended to reduce the risk of intra-abdominal infecti... Devices, Surgery, Venture CapitalAriste Medical, drug-eluting hernia mesh, hernia mesh, hernia repair (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - April 21, 2015 Category: Pharmaceuticals Source Type: news
Via Surgical Ltd. Receives FDA Clearance to Commercialize FasTouch(TM), the First Suture-Like Mesh Fixation System for Hernia Repair
AMIRIM, Israel, April 4, 2014 -- (Healthcare Sales & Marketing Network) -- Via Surgical Ltd., a leading developer of hernia mesh fixation technologies, today announced that it has received FDA 510(k) clearance to commercialize FasTouchTM. FasTouch fixatio... Devices, Surgery, FDAVia Surgical, FasTouch, hernia repair (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - April 4, 2014 Category: Pharmaceuticals Source Type: news