FDA: Transvaginal Mesh Not Worth the Risk in Treating Pelvic Organ Prolapse

Silver Spring, MDThe FDA reviewed Boston Scientific’s latest studies of the pros and cons of using transvaginal mesh to treat pelvic organ prolapse (POP) and doubled down on its earlier conclusion that the risks outweighed the benefits. In 2019, after a spate of surgical mesh lawsuits, the FDA ordered Boston Scientific to immediately pull its transvaginal mesh products off the market.

That may have prevented future health damage but it did not protect the patients who had already had surgical mesh implants. Those lawsuits continue to wind their way through the court system and have led to substantial settlements for patients who have been injured.

The FDA’s conclusions

In its August 16 advisory, the FDA concluded that:

“Boston Scientific transvaginal POP mesh had similar effectiveness and safety outcomes to native tissue repair at 36 months. The FDA continues to believe that devices of this type for transvaginal POP mesh repair presents potential additional risks compared to native tissue repair, including mesh exposure and erosion. Therefore, the FDA maintains that these devices do not have a favorable benefit-risk profile.”

In other words, transvaginal mesh offered no noticeable advantage over other treatment options, but it did expose patients to dangers like mesh erosion.

In April 2019, the FDA ordered Boston Scientific and Coloplast, the only two transvaginal mesh manufacturers remaining in the market, to stop selling and distributing their products immediately. It said neither company had demonstrated a reasonable assurance of safety and effectiveness for their devices.

In January 2012, it had ordered the manufacturers to conduct postmarket surveillance studies by manufacturers of the devices to address specific safety and effectiveness concerns related to mini-sling devices used to treat stress urinary incontinence and surgical mesh used for transvaginal repair of POP. At that point most manufacturers dropped out of the market, leaving only Boston Scientific and Coloplast to sell and distribute the medical devices.  

As early as 2008, the FDA issued a warning regarding the potential complications of transvaginal mesh devices. At the time however, the agency concluded that complications were rare. In 2011, this warning was amended to state that complications were actually not rare and these devices actually put patients at a much higher risk of complications and injury and that these devices were no more effective than any of the other procedures available.

FDA finds that transvaginal mesh complications are NOT rare

Transvaginal mesh is a net-like implant used to treat stress urinary incontinence. Doctors rely on the product to reinforce a weakened vaginal wall or support the urethra or bladder neck. Doctors in the United States reportedly performed about 300,000 surgeries for POP in 2010. At the height of synthetic mesh use in 2006, one-third of all POP surgeries used mesh.  

Transvaginal mesh has been described as one of  medtech’s “worst failures.” In 2011, the FDA reported that it had received 2,874 reports of injury, death, malfunctions and other complications related to transvaginal mesh surgeries between January 1, 2008 and Dec. 31, 2010. These injuries and complications include :

• Bleeding;
• Infection;
• Mesh erosion;
• Organ perforation;
• Nerve damage;
• Neuro-muscular problems;
• Organ perforation;
• Pain, including painful sexual intercourse; and
• Vaginal scarring and shrinkage.

Among the most common complications, erosion occurs when the mesh wears through tissue and becomes visible through the vagina. Less common problems involve the mesh going into the bladder, the urethra or the rectum, depending on where the mesh was placed. Vaginal mesh erosion can require multiple surgeries to correct and may result in continued pain even after the mesh is removed.

Surgical mesh lawsuits and settlements

In March 2021, Boston Scientific agreed   to pay $188.6 million to 47 states and the District of Columbia to resolve claims that it deceptively marketed transvaginal surgical mesh devices. The complaint alleged that the company failed to disclose the full range of potentially serious and irreversible complications caused by mesh. Boston Scientific also committed to marketing, training and clinical studies reforms.

Johnson & Johnson and its Ethicon unit reached a similar $117 million multistate settlement over the devices in 2019, and Becton Dickinson and Co and its CR Bard unit reached a $60 million agreement in September 2020. Lawyers estimate that settlements between the industry and more than 100,000 women may reach $11 billion.