Latest Settlement and Recall News for Medical Devices

  • Stealth Recall of Atrium C-Qur Mesh Occurring, According to Court Filing
    female-patient-with-doctor-300x200Atrium Medical, the manufacturer of C-Qur mesh, may have begun a what a court filing terms a “stealth” recall of certain kinds of the product due to allegations that products used in its manufacture increased the risk of hernia mesh complications. A stealth recall means that the company has simply...... Read more »
  • Endo International Shuts Down Vaginal Mesh Manufacturing Division
    vaginal-mesh-Image-506x311--300x184Embattled healthcare products company Endo International has announced that it has shuttered its Astoria Women’s Health division. This move has come on the heels of the company’s failure to identify a buyer for that division. Astoria Women’s Health division was based on Eden Prairie, Minnesota before it permanently closed its...... Read more »
  • NJ Woman Awarded $13.5 Million Vaginal Mesh Judgement
    vaginal-mesh-Image-506x311--300x184A New Jersey woman has received a $13.5 million vaginal mesh award from Ethicon, after a Philadelphia Court of Common pleas jury ruled in her favor in mid-February. Sharon Carlino filed a lawsuit against the company, claiming she was severely injured by the product manufactured by the Johnson & Johnson...... Read more »
  • Transvaginal Mesh Settlement Costs J&J $120 Million
    vaginal-mesh-Image-506x311--300x184The multi-sector health care company, Johnson & Johnson (J&J), has agreed to pay upwards of $120 million to resolve thousands of lawsuits filed by women who sustained injuries after utilizing their transvaginal mesh devices. This first settlement from the company’s Ethicon Inc. unit—which will compensate 2,000 to 3,000 women—is the initial move...... Read more »
  • FDA Issues Orders Concerning Safety of Vaginal Mesh Products
    vaginal-mesh-Image-506x311--300x184A condition known as pelvic organ prolapse, or POP, can cause significant pain and discomfort for women, causing many to seek medical intervention and treatment. In general, POP is caused by weakened pelvic floor muscles, which in turn causes surrounding organs to essentially “fall” into the vaginal canal. For women experiencing...... Read more »
  • J&J’s Ethicon to Pay $12.5 Million in Vaginal Mesh Verdict
    lawyer-and-jurors-300x200On December 21, a woman scored a major victory over Johnson & Johnson’s Ethicon subsidiary, when a jury found the manufacturer liable for gross negligence and reckless disregard for the safety of consumers for its Prolift vaginal mesh product. $12.5 million mesh verdict A Philadelphia Court of Common Pleas jury awarded...... Read more »
  • Vaginal Mesh Lawsuit Alleges Severe Injuries, Misleading Marketing Tactics
    vaginal-mesh-Image-506x311--300x184On October 7, 2015, a lawsuit was filed in U.S. District Court for the Eastern District of Louisiana alleging severe injuries caused by pelvic mesh products known as InteXen and the BioArc Trans Obsturator Subfacial Hammock, both of which are implanted to help curtail the effects of stress urinary incontinence...... Read more »
  • Boston Scientific Mesh Judgement Slashed to $10 million
    vaginal-mesh-Image-506x311--300x184A plaintiff who was awarded a substantial jury award in her transvaginal mesh lawsuit recently had verdict reduced. Judge Mary Johnston of New Castle County in Delaware ruled that the original $100 million jury award was “grossly disproportionate to the injuries suffered and shock the court’s conscience and sense of justice.” However,...... Read more »
  • TX Jury Rejects Plaintiff’s Claims Against Ethicon Regarding Gynecare Mesh
    lawyer-and-jurors-300x200A Texas jury has rejected a plaintiff’s claims that Ethicon should be held responsible for injuries related to the company’s Gynecare Prosima Pelvic Floor Repair System, implanted to treat pelvic organ prolapse. According to her complaint, the plaintiff was implanted with the Gynecare Promisa system on April of 2012 and...... Read more »
  • Bladder Sling Study Evaluates Risk of Revision Surgery
    female-patient-with-doctor-2-300x202Thousands of women have reported bladder sling injuries to the FDA and to date more than 70,000 patients who have received the implants have filed transvaginal mesh lawsuits against a handful of manufacturers. Recently, Canadian researchers sought to establish the percentage of women who might expect to undergo revision surgery...... Read more »
  • You Spoke, FDA Listened: New Patient Engagement Collaborative, Call for Nominations
    By: Nina L. Hunter, Ph.D., and Rachel E. Sherman, M.D, M.P.H. The FDA is committed to collaborating with patients, caregivers, and advocates, as well as incorporating the various perspectives from these groups into the FDA’s regulatory decision-making processes. And we … Continue reading →... Read more »
  • Looking ahead: Some of FDA’s major policy goals for 2018
    By: Scott Gottlieb, M.D. Twice a year the federal government publishes the “Unified Agenda of Federal Regulatory and Deregulatory Actions” (Unified Agenda), which provides the American public with insight into regulations under development or review throughout the federal government. For … Continue reading →... Read more »
  • New Steps to Facilitate Beneficial Medical Device Innovation
    By: Scott Gottlieb, M.D. and Jeffrey Shuren, M.D., J.D. In recent days, the Food and Drug Administration (FDA) has committed to several new policies that will modernize the agency’s approach to regulation in the medical device system. For instance, we … Continue reading →... Read more »
  • Treating Infections – FDA is Forging a More Efficient Path to Help Healthcare Providers Treat their Patients
    By: Edward M. Cox, M.D., M.P.H. When a patient has an infection, healthcare providers often order a test to help them select a drug that is likely to work against that infection. This testing is performed by laboratories and is … Continue reading →... Read more »
  • Bringing Early Feasibility Studies for Medical Devices Back to the United States
    By: Maureen L. Dreher, Ph.D., Andrew Farb, M.D., and Owen Faris, Ph.D. Ten years ago, when medical device manufacturers wanted to gain early clinical experience with their new devices they often went overseas to conduct first-in-human or small clinical studies. … Continue reading →... Read more »
  • Advancing Policies to Promote Safe, Effective MedTech Innovation
    By: Scott Gottlieb, M.D. Advanced technologies, biomaterials and digital tools are offering us fundamentally better ways to develop new medical devices to advance human health. To build on these innovations and ensure patients have access to safe and effective advances … Continue reading →... Read more »
  • FDA-Required Studies of Approved Drugs Make a Big Difference for Public Health
    By: Peter Stein. M.D. Drugs are approved by FDA based upon substantial evidence from clinical trials that the medicine will be both effective and safe for use if prescribed according to its labeling. However, there may be issues that need … Continue reading →... Read more »
  • FDA Launches Predictive Toxicology Roadmap to Enable Advances in Toxicity Testing
    By: RADM Denise M. Hinton and Suzanne Fitzpatrick, Ph.D. Toxicology testing plays a pivotal role in ensuring the safety of FDA-regulated products. During the development and evaluation of almost all FDA-regulated products, testing is performed on people or animals to … Continue reading →... Read more »
  • Communication, Breaking Down Walls, and a Huge Step Forward for People with Type 1 Diabetes
    By: Courtney Lias, Ph.D., and Stayce Beck, Ph.D., M.P.H. At FDA’s Center for Devices and Radiological Health (CDRH) we recognize that medical innovators with a novel technology can get lost in navigating the regulatory landscape if there is no well-worn … Continue reading →... Read more »
  • PEPFAR: FDA Approves 200th HIV/AIDS Therapy
    By: Scott Gottlieb, M.D. Since 1981, when the first case of AIDS was reported in this country, U.S. and foreign governments, scientists, grassroots and global community health organizations, patients, and their families have worked hard to address the impact of … Continue reading →... Read more »