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 :
- Mesh erosion;
- Organ perforation;
- Nerve damage;
- Neuro-muscular problems;
- Organ perforation;
- Pain, including painful sexual intercourse; and
- Vaginal scarring and shrinkage.
Surgical mesh lawsuits and settlements
READ MORE SURGICAL MESH LEGAL NEWS
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.