North Carolina Defective Medical Device?: FDA Warns of Serious Complications from Using Transvaginal Mesh to Repair Pelvic Problems
The FDA says that serious complications have been linked to surgical mesh that is implanted in the body to repair pelvic organ prolapse and stress urinary incontinence. While the federal agency had issued an early warning in October 2008 about health risks linked with using this medical device to treat SUI and POP, now the government wants surgeons and patients to know that serious complications are not rare. Also, the FDA says that it is unclear whether transvaginal POP repair using mesh is in fact more effective than opting for non-mesh repair to treat the same pelvic problems.
If you or someone you love suffered the following complications after undergoing transvaginal POP repair using surgical mesh, do not hesitate to contact our Charlotte, North Carolina defective medical device law firm today:
• Mesh erosion through the vagina
• Urinary problems
• Organ perforation
• Neuro-muscular problems
• Vaginal scarring
• Vaginal shrinkage
• Emotional issues
The FDA says that it has received more than 2,000 reports of complications from use of surgical mesh. Many of these reports came from the manufacturers of these devices. Some patients had to undergo additional surgeries and hospitalization and experienced impaired quality of life.
Our North Carolina transvaginal mesh lawsuit law firm cannot stress how important it is for manufacturers to make products that will not cause injury or other health complications for a patient. With so many women suffering from some type of pelvic prolapse—the Los Angeles Times reports that up to 50% of all women end up suffering from this condition, which involves organs (bladder, uterus, bowel, rectum, or intestines) slipping out of place following a hysterectomy, menopause, childbirth, or with age—this condition requires treatment more often than one would think. Some 75,000 such procedures are conducted annually.
Mesh used in pelvic surgeries under scrutiny, Los Angeles Times, July 25, 2011
FDA warns against surgical mesh to repair pelvic problems, Boston.com, July 13, 2011
FDA Safety Communication: UPDATE on Serious Complications Associated with Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse, FDA, July 13, 2011
Related Web Resources:
Pelvic Organ Prolapse, American Urogynecologic Society
Stress incontinence, MedlinePlus
More Blog Posts:
Approximately 1,000 DePuy Hip Lawsuits Already Filed Against Johnson & Johnson, North Carolina Injury Lawyer Blog, July 7, 2011
Protecting Americans from Defective Medical Devices: Is the FDA Doing Enough?, North Carolina Injury Lawyer Blog, February 18, 2011