Johnson & Johnson vaginal mesh lawsuits another blow to the FDA’s device review process

Transvaginal mesh

The FDA’s medical device review process is again under scrutiny as lawsuits pile up against health care leviathan Johnson & Johnson (NYSE:JNJ) for transvaginal mesh devices that may do more harm than good.

Lawsuits claiming negligence against mesh-makers have also implicated the FDA’s review system for continuing to clear new mesh products under the 510(k) system, despite the predicate device being pulled from U.S. shelves.

Boston Scientific Corp.’s (NYSE:BSX) ProteGen mesh, cleared in 1996 and pulled from the shelves a year later, was used as a predicate device for clearing subsequent mesh products, despite more than 120 adverse event reports on the original design at the time, Bloomberg reported.

"The FDA got caught with their pants down," California pelvic surgeon Thomas Margolis told the news service. "The ProteGen should have told them, ‘Wait a minute, all of these mesh systems are bad.’"

Legal challenges continue to pile up against mesh-makers, including J&J, C.R. Bard Inc. (NYSE:BCR), American Medical Systems Holdings Inc. (NSDQ:AMMD) and Boston Scientific Corp. (NYSE:BSX).

The bad news for the watchdog agency is still more critical scrutiny, on top of the high-profile metal-on-metal hip implant recalls by J&J subsidiary DePuy Orthopaedics, which has spawned its own raft of lawsuits. Analysts have estimated that settlement of those cases could cost JNJ up to $1 billion.

Medtronic Inc.’s (NYSE:MDT) 2007 Sprint Fidelis recall, another sore spot for the FDA’s review system, was implicated in more than 100 deaths, although Medtronic has said that only 13 fatalities had the leads as a "possible or likely contributing factor."

Transvaginal mesh, Depuy’s hips and Medtronic’s Sprint Fidelis were all cleared through the FDA’s 510(k) device review fast-track.

Concerns about transvaginal mesh were used as an archetype for grievances with the 510(k) system at last month’s public meeting on the Institute of Medicine’s audit of the FDA’s device review process. The meeting followed the IOM’s controversial report concluding that the 510(k) broken was too broken to be fixed and should be discarded entirely.

"Patients across America are being put at risk by life-threatening medical devices implanted for a non-life threatening condition: Weakened or torn tissue," Lana Keet, president of patient advocacy group Truth in Medicine, told the CDRH at a public meeting last month. "You don’t usually hear of someone dying of a hernia or incontinence or pelvic organ prolapse. But patients do die at alarming rates from the 510(k)-cleared medical device, synthetic surgical mesh."

The mesh hullabaloo stems from a July report by the FDA’s Obstetrics & Gynecology Devices Panel. The group recommended bumping the devices, which are used to treat pelvic organ prolapse, into a higher risk category given rising concerns that they may expose patients to unnecessary risk without offering clinical benefit above safer options.

RSS From Medical Design & Outsourcing

  • Molex delivers ISO 13485-compliant, medical-grade surgical cables from its class 100,000 clean room facility
    Molex, LLC operates a fully ISO 146441-1:1999 Class 8-certified clean room, satisfying strict particulate contamination levels specified by ISO-compliant requirements. Located in Thailand, the facility has less than 100,000 particulates (≥0.5µm) per cubic foot of air and manufactures a variety of ISO 13485-compliant medical cables and surgical cables used in operating theatres, hospitals, laboratories and […]
  • Swept-Source OCT: Patent license agreement between Massachusetts General Hospital and Heidelberg Engineering
    Heidelberg Engineering has entered into a patent license agreement with Massachusetts General Hospital (MGH) in Boston. The agreement grants global and exclusive rights to 77 basic patents and patent applications which relate to swept-source OCT technology and its application in ophthalmology. Spectral domain OCT has become indispensable to eye care professionals worldwide to diagnose and […]
  • MIT’s MultiFab presents a stark challenge to incumbent 3D Printer manufacturers’ hardware, software, and business Models
    MIT’s Computational Fabrication Group recently announced the MultiFab, a low-cost 3D printer that can combine up to 10 different resins in one part and also includes a 3D scanning system to identify and fix errors during production. According to Lux Research, these capabilities are rare in commercial 3D printers today due to the manufacturers’ need […]
  • AVX releases Accu-P MP medical grade film chip capacitors for medical devices
    AVX Corporation, a leading manufacturer of passive components and interconnect solutions, has released a new series of thin film chip capacitors specifically designed to meet the demanding performance specifications for implantable medical devices. Delivering extremely tight capacitive tolerances, exceptionally repeatable performance, and remarkably low ESR and high Q at high frequencies—including VHF, UHF, and RF […]
  • RIVANNA commences manufacturing of its Accuro device
    Rivanna Medical announced that it has begun manufacturing its FDA-cleared Accuro device, a handheld and untethered smart-phone-sized device that is designed to guide spinal anesthesia with automated 3D navigation technology in addition to ultrasound imaging of abdominal, musculoskeletal, cardiac and peripheral vascular anatomies. The product will be launched at the ASA annual meeting in San […]
  • FDA seeks public input on Quality Metrics guidance
    by Oliver Wolf, Senior Product Manager, MasterControl In line with the general shift towards risk-driven approaches in the quality management world, FDA is now taking steps towards applying those same principles to its own auditing schedule. At the end of July, the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation […]
  • First ‘Ear Wear’ for Active Adults Debuts with MDHearingAid FIT
    If you’ve burned out your ears with earbuds, headphones or decades of other audio abuse but aren’t ready for your grandmother’s hearing aids, not to worry! The new MDHearingAid FIT gets you back in the game with a tiny, FDA-registered, one-size-fits-most solution that doesn’t block your ear canal like old-fashioned in-the-ear hearing aids. The FIT feels […]
  • CardioGenics enters into manufacturing agreement with Ontario-based Plasticap
    CardioGenics Holdings, developer for the In-Vitro-Diagnostics (“IVD”) testing market, announced that it has entered into a manufacturing agreement with Plasticap of Ontario, Canada, pursuant to which Plasticap will manufacture CardioGenics’ proprietary self-metering cartridges for its QL Care analyzer. The term of the agreement is three years and the purchase price for each cartridge shall be […]
  • MTD Micro Molding releases micro materials menu
    MTD Micro Molding, a long-time leader in micro-injection molding, has released an updated “Materials Menu” of materials that can be successfully micromolded to help guide engineers at medical device companies. Material selection is a crucial step in product manufacturability. The correct material drives tolerance, dimension, strength, usabality, speed-to-market, design, critical features, and cost. Through MTD’s […]
  • MedTech Chat: Elastic technology for drug delivery
    Dr. Zhen Gu and Dr. Yong Zhu from North Carolina State University are both co-senior authors of a research paper describing their recent work. Dr. Gu, Dr. Zhu and other researchers from North Carolina State University and the University of North Carolina at Chapel Hill have developed a drug delivery technology that consists of an […]
  • B. Braun’s OEM Division offers large bore normally closed low-pressure check valves
    Infusion therapy and pain management device manufacturer B. Braun said today it is offering normally closed large-bore low-pressure check valves through its valve-focused contract manufacturing OEM division. The valves, offered by Bethlehem, Pa.-based B. Braun, are designed for the intermittent injection of fluids during medical treatment and open automatically when pressure is applied. The newly […]

Leave a Reply