Joint replacements are the #1 expenditure of Medicare. The process of approving these medical devices is flawed according to the Institute of Medicine. It is time for patients' voices to be heard as stakeholders and for public support for increased medical device industry accountability and heightened protections for patients. Post-market registry. Product warranty. Patient/consumer stakeholder equity. Rescind industry pre-emptions/entitlements. All clinical trials must report all data.
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Saturday, July 22, 2017

Surgical Mesh Lawsuits Proliferate as Industry Suppresses Patient Outcome Harm






Female Pelvic Med Reconstr Surg. 2017 Jun 27. doi: 10.1097/SPV.0000000000000433. [Epub ahead of print]
Abstract
OBJECTIVES:
Following Food and Drug Administration communications about the safety of transvaginal prolapse, more than 73,000 patients with complications from treatment of pelvic organ prolapse (POP) or stress urinary incontinence (SUI) have filed product liability claims. This research analyzes the transvaginal mesh claims filed in the United States to identify key characteristics that may inform clinical decision-making.
METHODS:
We evaluated a 1% random sample from the Bloomberg Law Database: 2000 to 2014 and associated legal documents. Outcomes and measures used included annual rate of claim, mesh type, time interval between surgery and claim, defendants, and surgeon training.
RESULTS:
The search returned 76,865 results, and 2979 were excluded, leaving 73,915 claims. Of 739 claims (1%), 63.3% involved slings for SUI, 13.3% mesh for POP, and 165 (23.2%) involved both. The mesh named most often in claims was retropubic slings at 30.3% and transobturator slings at 27.1%. The number of cases filed increased significantly from 730 in 2011 to 11,798 in 2012, which then almost tripled in 2013 to 34,017. The interval from surgery to claim filing ranged from 4.8 to 5.3 years. Only 12% of implanting surgeons were or became board certified in Female Pelvic Medicine and Reconstructive Surgery. Only 4 cases named providers as codefendants.
CONCLUSIONS:
Most legal claims involved slings for SUI and began after the 2011 Food and Drug Administration communication about mesh for POP. The rise in lawsuits does not reflect the acceptably low complication rates for slings for SUI reported in the literature.

PMID: 28657986 DOI: 10.1097/SPV.0000000000000433

2 comments:

  1. Medical literature's reporting of complications with mini slings like TVT Secur do not reflect the experiences of women with mesh complications. Most of the women on support sites for mesh injured women have SUI slings causing them horrendous problems that carry on for years. Surgeons who fail to report SUI sling complications should be penalized. sadly. many of them don't recognize them, and minimize the problems, discount patient's pain. and can't fix the problems they created putting plastic into bodies that cannot tolerate the foreign body response to mesh. Chronic inflammation is causing Implant Syndrome, and ASIA (Autoimmunity Symptoms Induced by Adjuvants) Women need to be empowered to report problems with medical mesh implant materials, as it appears the medical community has not been telling the whole truth about mesh implants.

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