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Doctors began implementing surgical mesh in various procedures to correct organ prolapse and hernias in the mid 20th century. By the 1990’s, patients found hope in the idea of utilizing mesh products for treating pelvic organ prolapse (POP) and stress urinary incontinence. Noted for effective results in corrective treatments while claiming few adverse reactions, transvaginal mesh received approval by the U.S. Food and Drug Administration in 2002.
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.
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:
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.
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.
While aware of transvaginal mesh products entering the market as an inadequately researched treatment, manufacturers and marketers failed to remind patients of this factor. According to Rachel Zimmerman with CommonHealth, officials informed patients in February of 2007 that the products should be regarded as “experimental” due to the changes that transvaginal products had faced in the past as well as “limited data” in existence related to transvaginal mesh. Strangely, in future bulletins relayed to patients, the information excludes the warning of transvaginal mesh as an “experimental” procedure. This negligence on behalf of officials downplayed the seriousness of the risk involved in mesh implants and deceived victims of these adverse reactions.
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
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