Is The FDA Doing Enough To Prevent Mesh Injuries?

Over the last couple of years, there has been a significant increase in the use of surgical mesh over the more traditional non-mesh surgical options. For quite some time, doctors have been using Surgical Mesh mostly to treat women with Pelvic Organ Prolapse (POP) and SUI (Stress Urinary Incontinence). However, the surgical mesh is also used to treat men with hernia problems.

According to, as early as 2008, the Food and Drug Administration (FDA) had sent warnings to doctors and members of the public concerning the use of surgical mesh. By 2012, the number of Transvaginal Mesh lawsuits filed against the manufacturers of pelvic mesh products had increased significantly. According to a majority of the cases, “the manufacturers had a legal duty of ensuring the effectiveness and safety of their products.”

FDA Public Health NotificationFor some years now, there are tens of thousands of women who have suffered physical injuries as a result of using Transvaginal Mesh. In addition to their physical injuries, they have also suffered emotional and financial distress. In fact, many women have had to undergo more complicated and expensive surgical procedures to have the mesh removed.

However, it’s difficult to know whether the FDA knew about these medical complications of Transvaginal Mesh products. For instance, why is it that these products were never studied for their long-term effects, and were still certified for used? These rise of Transvaginal Mesh lawsuit cases seems appropriate based on obvious negligence.

The FDA has, however, distanced itself from the issue claiming that it has done more than what they are reasonably supposed to have done. However, it is still important to know whether the FDA needs to be permitted to do more than they are legally supposed to.

The reason plaintiffs are winning millions from their Transvaginal Mesh lawsuits probably indicates that the FDA needed to have done a lot more doctor holding up mesh before allowing these products onto the market. For instance, Coleen Perry was awarded $5.7 million after suing Ethicon (a subdivision of Johnson & Johnson’s) for the debilitating pain caused by their mesh products.

Although, the manufacturers are to blame and probably a few doctors, the FDA needs to take the largest responsibility. The agency never took the time to review carefully or inspect the product before allowing it to be released to the public; hence leaving women forced to file a Transvaginal Mesh lawsuit.

This is an indication that the government is not doing enough to prevent medical malpractice. Of particular importance is the statement of the presiding jury in the case of Coleen Perry. In the decision, the jury agreed by awarding $5 million in punitive damages. This judgment was meant to punish Ethicon into acknowledging its illegal, unethical, and dangerous behavior.

Paula Munos: Woman Living With Recalled MeshFor a court-of-law to realize these facts, then it means that the government failed in regulating the way the products were manufactured, tested, and finally introduced to the market.

In order to deal with the escalating problem, it is important that in the meantime a ban be placed on the use of the mesh products. This will give the FDA, other government agencies, manufacturers, as well as the medical fellowship, ample time to evaluate the effectiveness and safety of these products. A Transvaginal Mesh lawsuit places such emotional burden on a woman that has already suffered a personal health trial. This issue has to become the woman rights issue of the 21st century!