The US Food and Drug Administration is proposing that surgical mesh products be subject to tougher regulations. The mesh products, which are placed in the vagina to treat pelvic organ prolapse and stress urinary incontinence, can cause serious injuries. In an update to its 2008 advisory warning that transvaginal mesh products can serious complication, last month the federal agency announced that these complications are not rare.
If you or someone you love has experienced bleeding, organ perforation, infection, urinary issues, and severe pain after undergoing a transvaginal mesh procedure, you may have reason for filing a Washington DC products liability case against the manufacture of the surgical mesh products. These medical devices are currently manufactured by about nine companies, including Boston Scientific Corp. and Johnson & Johnson.
Now that the FDA believes that the severity and rate of injuries related to surgical mesh to treat POP repair are serious enough to raise questions about the safety of these medical devices, the federal agency is proposing that new mesh products go through a premarket review process. This would require companies to conduct studies examining a product’s effectiveness and safety before it is approved. Right now, mesh products are subject to the 510(k) process, which is less rigorous.
According to consumer advocacy group Public Citizen, of the almost 300,000 women who underwent surgery for pelvic organ prolapse in 2010, nearly 67,500 women underwent procedures involving a mesh product that was implanted in their vaginas. From these transvaginal procedures, federal regulators received 1,503 reports of complications, such as mesh implant erosion and pelvic organ injuries. Also, surgical mesh-related complications may require a woman to undergo more surgeries, which can place her at risk of additional complications and decrease her quality of life.
Our Washington DC personal injury lawyers represent clients that have sustained injury, illness, infection, or died because the medical device they used proved unsafe, dangerous, defective, and/or worsened their condition or health.
Public Citizen calls for a ban of surgical mesh devices, NJ.com, August 25, 2011
FDA Planning Tougher Regulations For Surgical Mesh, The Wall Street Journal, August 31, 2011
Related Web Resources:
Pelvic Organ Prolapse, Web MD
Stress urinary incontinence, NIH
More Blog Posts:
Are Some Children Undergoing Unnecessary CT Scans?, Washington DC Injury Lawyer Blog, May 11, 2011
Dangerous Medical Device?: Woman Files Cold Therapy Lawsuit Against DeRoyal Industries Alleging Tissue Damage, Maryland Accident Law Blog, June 18, 2011
US Lawmakers Seek to Reinstate Right to Sue Medical Device Makers for Personal Injury and Wrongful Death, Maryland Accident Law Blog, February 19, 2009
Contact our DC defective medical device law firm to request your free case evaluation.