However, today transvaginal mesh is known as a risky procedure which can leave patients in devastation. Among the most serious complications of transvaginal mesh implants include infections, erosion, scarring and perforation of nearby organs. Perhaps the most critical reactions involve the psychological harm and depression caused by the extreme pain and recurrence of prolapse and other side effects.
The Downfall of Transvaginal Mesh
Amidst the flashing news reports of transvaginal mesh lawsuits and case settlements lie a variety of concerns with the once highly-praised product. Patients and officials alike argue the following issues:
- poor regulation on behalf of the FDA and manufacturers of the mesh
- sufficient amounts of research and experiments had not been conducted
- negligence in warning of the potential for adverse reactions
- flaws in surgical procedures and design of the product
After being utilized in surgeries for over 60 years, it seems as if mesh products would be a fairly safe method for reducing symptoms of POP, stress urinary incontinence, and other related difficulties. Furthermore, the granting of approval for transvaginal uses by the FDA should indicate a general level of assurance for implanting the product. But, this “approval” may be one of the most shocking issues in the history of transvaginal mesh.
FDA Approval or “Clearance”
The FDA approved transvaginal mesh through the its 510 K Clearance Program. This approval program allows officials to find a significantly similar product which had been on the market before May 28, 1976. Manufacturers may then expedite and even skip certain procedures in the approval process and begin marketing the product. In other words, transvaginal mesh had not been required to undergo rigorous experiments or meticulous research by the FDA and instead was given approval based off of previous mesh products which had been supported by officials.
Before reaching the market, transvaginal mesh had solely been tested on animals. Therefore the true consequences of side effects in humans related to mesh products for POP and transvaginal use were not fully understood. Unfortunately, this resulted in the selling and implantation of unknowingly high-risk transvaginal mesh products in thousands of women around the world.
Manufacturing and Marketing Negligence
For these several areas of concern, transvaginal mesh has become one of the most controversial procedures in the 21st century. Learn more about transvaginal mesh updates, lawsuits and information at bad-drug.net. If you have experienced an adverse reaction associated with transvaginal mesh, fill out our “Request Attorney Assistance” form located at the right section of this page to get the compensation you deserve through our attorneys.
Sources: http://commonhealth.wbur.org/2011/11/surgery-under-scrutiny-what-went-wrong-with-vaginal-mesh