Category: Medical Devices

Posts related to Medical Devices

FDA Strengthens Rules On Transvaginal Mesh

Women Filing Lawsuits Now Due To Injuries Suffered After POP Treatment
Surgery

This week the FDA responded to concerns about the safety of mesh implants to treat pelvic organ prolapse (POP) in women. They have been reclassified with its highest risk category and manufacturers of existing products must submit premarket approval applications within 30 months. According to a statement by the FDA, the applications are required “to support the safety and effectiveness” of the mesh products.

POP is caused when the bladder, bowel and uterus are no longer supported by weakened or stretched pelvic floor muscles. Women may develop POP as a result of childbirth, hysterectomy, or menopause. If left untreated, POP can cause pain and urinary leakage.

SurgeryIn the 1990s, gynecologists started using surgical mesh transvaginally to repair POP, reinforcing pelvic muscles and reducing recuperation time. The FDA okayed the [...]

New Study Shows Risk Of Second Vaginal Mesh Surgery

1 in 30 Women May Need Revision Surgery
medical device

Approximately 1 in 30 women opting for vaginal mesh surgery to treat urinary stress incontinence will have to either remove or replace the mesh within 10 years according to this study.

On September 9, 2015, JAMA Surgery published online the results of a 10 year study at Western University in Ontario, Canada. Researchers followed the results of 59,887 women who had mesh implanted by around 1000 surgeons over the course of the study. The data showed that after 5 years, 2.2% needed a revision surgery while the number increased to 3.3% after 10 years. This means a woman’s odds of needing to have a second mesh surgery could be 1 in 30.

One interesting conclusion noted by the researchers is that the patients of surgeons who did higher volumes of mesh surgery had better outcomes. Apparently, it doesn’t seem to matter if the surgeon specialized in gynecology or in [...]

Don’t File Your Transvaginal Mesh Lawsuit Before You Read This – 4 Important Facts You Should Know!

If you or a loved one had transvaginal mesh surgery, you may be eligible to file a lawsuit for compensation from the manufacturer. The US Food and Drug Administration (FDA) have issued a statement that serious complications associated with the surgical mesh used in transvaginal placement can occur. In addition, the FDA has warned that transvaginal mesh may not be more effective in certain situations than non-mesh repairs and that is may expose patients to a greater risk of adverse side effects.

What is Transvaginal Mesh?

Transvaginal mesh is a medical device used to repair weakened or damaged tissue and placed through the vagina. It is made from either porous or non- porous absorbable synthetic material or absorbable biologic material. Transvaginal mesh is used to repair pelvic organ prolapse (POP) by being permanently implanted to reinforce the weakened [...]

Back to top