Since the 1990s, millions of women have relied on vaginal mesh prodcuts for the correction of pelvic organ prolapse; a condition that’s characterized by weakened pelvic muscles and the subsequent sagging of organs such as the uterus and bladder into the vaginal area. About four months ago, however, the U.S. Food and Drug Administration placed a ban on the sale of such products in the country. According to the agency, the manufacturers of vaginal mesh products “have not demonstrated a reasonable assurance of safety and effectiveness of these devices.”

The decision did not come as a surprise as it follows years of patient complaints and litigations against the major manufacturers of the product. Thousands of women have come forward to claim that their use of vaginal mesh products resulted in severe injuries and some companies have had to pay huge amounts as fines or settlements. 

Right timing? 

Three years ago, the FDA reclassified vaginal mesh products as high-risk and there has already been a significant decrease in the proportion of women agreeing to have mesh implants. However, it appears that move has proven insufficient thus far, with many women still reporting complications and legal battles still ongoing. 

The embargo on sales represents the FDA’s most decisive action since the litigations against mesh manufacturers began but women and activist groups feel it’s a decision that should have been made much earlier. Considering the fact that similar moves have been made in Australia, New Zealand, and the UK since 2017, it’s hard to argue with the people who feel the FDA came to the party a tad too late. 

Who is affected by the ban? 

As at the time of the ban, Coloplast and Boston Scientific (BSX) are the remaining manufacturers and distributors of vaginal mesh in the United States. Boston Scientific, through their representative, revealed that they are “deeply disappointed” with the decision, claiming that the ban would “severely limit treatment options” for women with pelvic organ prolapse. Coloplast, on the other hand, did not issue an official statement. 

The FDA ban is specific to vaginal mesh products and not other kinds of pelvic mesh such as those used for hernia or urinary incontinence. Women who already have the vaginal mesh do not need to remove it except they are experiencing complications. All they have to do, according to the FDA, is continue regular checkups and report symptoms such as pelvic pain or bleeding. 

Is there a pattern here? 

In the wake of the ban, there have been fierce criticisms of the current regulatory pathway for the approval of medical devices. New medical devices are approved based on their similarities with devices that have been previously approved. For many, the vaginal mesh ban is only addressing a symptom and the root of the problem remains untouched. 

Let’s not forget that in 2018, the FDA placed stringent restrictions on Essure, a birth control implant that has been linked to severe pain, bleeding, and allergic reactions. And earlier, the FDA issued a warning concerning laparoscopic power morcellators, stating that they carry the risk of spreading cancer.  

In a bid to find a lasting solution to the problem, the FDA announced plans to overhaul the current system and devise updated testing standards for medical devices. We can only hope that the plans are fully implemented sooner rather than later.