MassDevice

The Medical Device Business Journal — Medical Device News & Articles | MassDevice

Home » FDA may revoke 510(k) clearances for transvaginal mesh products

FDA may revoke 510(k) clearances for transvaginal mesh products

By

FDA

Transvaginal mesh products may have their 510(k) clearance revoked and sellers like Boston Scientific Corp. (NYSE:BSX) and Johnson & Johnson (NYSE:JNJ) may have to submit new clinical safety data in order to keep the devices on the market.

The latest report from the watchdog agency’s Obstetrics and Gynecology Devices Panel recommends 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.

The new recommendations follow last month’s warnings, which in turn updated 2008 reports that addressed concerns about adverse events associated with the transvaginal placement of the mesh.

From 2008 to 2010, the FDA received 1,503 adverse event reports associated with mesh used for POP repair, five times as many as the agency received from 2005 to 2007.

Just yesterday Boston Scientific Corp. and American Medical Systems Holdings Inc. (NSDQ:AMMD) found themselves at the center of a lawsuit claiming that transvaginal mesh products sold by the companies were defective and caused severe injuries to a patient. Lawsuits were filed against C.R. Bard Inc. (NYSE:BCR) for its Avaulta transvaginal mesh, filed earlier this month.

"There are clear risks associated with the transvaginal placement of mesh to treat POP," said Dr. William Maisel, deputy director and chief scientist of the FDA’s Center for Devices and Radiological Health, in an agency release. "The FDA is asking surgeons to carefully consider all other treatment options and to make sure that their patients are fully informed of potential complications from surgical mesh. Mesh is a permanent implant — complete removal may not be possible and may not result in complete resolution of complications."

Consumer watchdog group Public Citizen filed a petition with the FDA earlier this month asking the agency to issue a recall for all transvaginal mesh products.

An FDA advisory panel is scheduled to hold a two-day meeting on Sept. 8 and 9 to develop recommendations for the use of transvaginal mesh.

In case you missed it

RSS From Medical Design & Outsourcing

  • Researchers tout biomaterials that can be ‘fine-tuned’ for medtech
    Researchers in the UK and U.S. are touting a new thermoplastic biomaterial capable of “fine-tuning” for use in soft tissue repair or bioelectronics. According to a news release, the material, which is a type of polyester, has been developed by a team at the University of Birmingham (UK) and Duke University (U.S.) for use in… […]
  • HHS could make permanent pandemic-related exemptions for some devices
    HHS has used the Trump administration’s waning days to propose permanently exempting certain medical devices — including infusion pump controllers and fetal monitors — from the FDA 510(k) clearance process. In a notice published Jan. 15, 2021, in the Federal Register, the agency also listed seven types of patient examination gloves that it has decided… […]
  • Medtechs can’t set digital strategies aside – DTW Podcast
    Digital connectivity no longer belongs in the final slides of a medtech company’s pitch deck. In the latest DeviceTalks Weekly podcast, three leaders pushing for connected medical devices explain the need to incorporate data collection and monitoring functionality in new devices: Scott Huennekens, who advanced the “digital surgery” strategy when he helped launch Verb Surgical,… […]
  • Protolabs to acquire 3D Hubs for up to $330M
    Protolabs (NYSE: PRLB) today announced it plans to acquire Amsterdam-based 3D Hubs, an online manufacturing platform that provides engineers with on-demand access to a global network of approximately 240 manufacturing partners. The transaction creates a comprehensive digital manufacturing offer for custom parts, expanding Protolabs’ breadth of capabilities as well as adding a broader offering of pricing and… […]
  • These medtech stocks performed the best in 2020
    While 2020 did not go as planned for anyone, with the twists and turns came opportunities for medtech companies to power forward. Innovations came both as a result of the COVID-19 pandemic and perhaps in spite of the challenges brought on by the virus, highlighted by the increased efforts to produce vaccines and testing while… […]
  • Covestro tests plastics against high-strength hospital disinfectants
    Covestro announced that it recently teamed with disinfectant manufacturer Metrex to test six different Covestro polycarbonate materials against three of Metrex’s products, which are widely used throughout the healthcare industry. As is customary for rapidly assessing the compatibility of plastics to disinfectants, test specimens were pre-strained and underwent several wipe-and-dry cycles with Metrex disinfectants to… […]
  • Integer expands N.Y. battery plant
    Integer announced today that it recently broke ground on an expansion of its Alden, N.Y., facility to accommodate new equipment that will substantially increase the plant’s production capacity for rechargeable Xcellion lithium-ion batteries. The project kicked off in mid-December 2020 and will add both production equipment and a build-out of Integer’s existing facility. The company… […]
  • Diversified Plastics adds high-efficiency vertical presses
    Diversified Plastics (DPI) announced that it recently installed six all-electric vertical injection molding presses. These presses will join DPI’s existing assemblage of vertical presses and provide increased production capacity to meet growing demand from medical device and other original equipment manufacturers (OEMs). DPI uses vertical presses for over-molding and insert-molding, capabilities often required for medical… […]
  • Traco Power expands power supply line for portable medical equipment
    Traco Power announced that it has expanded its TPP 450 high-density 3×5 power supply series. The series now offers Protection Class II models (TPP 450BA-M Open-Frame Models and TPP 450B-M Enclosed with Fan Models), designed for non-stationary requirements where connection to ground is not possible. Key approvals on the original series remain on the expanded… […]
  • Reflow Medical launches low-profile reinforced support catheters
    Reflow Medical today announced it has launched its Reflow Spex Low Profile reinforced support catheters. The Spex LP catheters are designed to provide the lowest profile tip to access and cross the tightest and most complex lesions with a supportive system. They come in 0.014 in. and 0.018 in. sizes and can be combined with… […]
  • Former CDER head Woodcock to lead FDA for now
    FDA veteran Dr. Janet Woodcock has been tapped as interim FDA commissioner by the Biden administration, according to published reports. An article by BioCentury also said that former FDA commissioner David Kessler, who had been mentioned as a possible replacement for current commissioner Stephen Hahn, will be a consultant to the agency but will not… […]

Leave a Reply