FDA Order Surgical Mesh Manufacturers to Stop Selling Devices
After years of consumers questioning the safety of surgical mesh implants for repairing a condition called pelvic organ prolapse (POP), The U.S. Food and Drug Administration (FDA) ordered manufacturers to stop selling these devices immediately.
The FDA’s announcement applies only to mesh placed vaginally to treat loose or weakened muscles and tissues that support the uterus, bladder or rectum. The halt of sales does not apply to mesh used for conditions such as hernias or stress urinary incontinence. The announcement was released after determining that the manufacturers, Boston Scientific and Coloplast failed to reasonably demonstrate the safety and effectiveness of the device.
The April 11 announcement comes due to the lack of sufficient evidence that assures the devices probable benefits outweigh their probable risks.
“In order for these mesh devices to stay on the market, we determined that we needed evidence that they worked better than surgery without the use of mesh to repair POP”, director of the FDA’s Center for Devices and Radiological Health Dr. Jeffrey Shuren said.
The companies were given 10 days to submit their plan to withdraw these products from the market.
What is Transvaginal Mesh?
Transvaginal mesh is a net-like medical device that originally used to repair hernias. The devices have since been adopted to treat stress urinary incontinence (SUI) and pelvic organ prolapsed (POP) in women. Since the 1990s, doctors have used the product to provide additional support when repairing damaged or weakened tissue during transvaginal POP procedures. When used to repair POP, the device is permanently implanted to reinforce the weakened vaginal wall.
Transvaginal mesh consequences
A number of women who underwent the transvaginal mesh procedure have reported prolonged problems including:
- Difficulty urinating
- Pain during normal activities
- Erosion of the mesh into the bladder or bowel
- Infection or irritation in the area
- General lower body pain
- Recurrence of prolapse (organs falling out of place)
- Painful sexual intercourse
For many, more than one surgery is required to repair damage caused by the transvaginal mesh. The FDA reported in 2011 that deaths from the repair surgeries along with complications from the mesh devices were not rare. Thousands of lawsuits have since been filed against the manufacturers.
FDA warns public of Transvaginal Mesh Side Effects
Each year, more than 100,000 women are fitted by healthcare professionals with surgical mesh to offer additional support for POP. Nearly 4,000 injuries were reported to the FDA in connection with transvaginal/pelvic mesh devices between 2005 and 2010.
Over the last several years, the FDA has issued the following warnings to the public about transvaginal surgical mesh:
July 2011– The FDA issued a Safety Communication identifying concerns about the use of surgical mesh for transvaginal repair of POP.
September 2011– The FDA issued 131 orders to conduct postmarket surveillance studies to 34 surgical mesh for transvaginal repair of POP after discussing the benefits and risk of this use.
January 2016– Surgical mesh for transvaginal repair was reclassified from a moderate-risk device to the highest risk class of devices, class III. A class III categorization requires premarket approval (PMA) applications in order to remain on the market.
July 2018– The deadline for applications to be filed for premarket approval for any surgical mesh marketed for transvaginal POP repair was July 5, 2018. Therefore, those manufacturers that failed to file PMAs by the deadline were required to withdraw their products from the market. The FDA allowed the manufacturers that filed PMAs to keep their products on the market while in review.
February 2019– The FDA held an advisory committee meeting in an effort to gather expert opinion on how to evaluate the risks and benefits of surgical mesh for transvaginal repair of POP. This consisted of scientific and clinical input on the effectiveness, safety and benefit-risk of mesh placed transvaginally.