It was in 1976 when Congress passed the Medical Devices Amendments defining the required steps for medical device manufacturers to gain the FDA clearance to sell their products. This process is known at the 501(k) process.
The FDA separates medical devices into three categories based on their potential risks and the ability of post-market controls to manage them. With medical devices that are classified as a Class II (low to moderate risk), the manufacturers are only required to notify the FDA ninety days before the company markets them. An interesting factor to note though is if a Class II device is substantially similar or equivalent to a medical device that has already been approved, the FDA allows the marketing and sale of the new device WITHOUT requiring clinical tests.
About 90% of medical devices have been approved for sale through the FDA’s 510(k) process. One of those major medical devices approved through this process is the transvaginal surgical mesh. Surgical mesh was first used in the 1950s to reinforce and support weakened soft tissue or bone. It was in the 1970s when gynecologists started using surgical mesh to reinforce vaginal tissue in order to treat pelvic organ prolapse. Pelvic organ prolapse occurs when the tissue that holds together the pelvic organs becomes weak and then the organs bulge into the vagina. In the 1990s, surgical mesh was used to treat stress urinary incontinence in women.
Based on best available estimates, approximately 500,000 women choose to undergo mesh surgery annually to treat pelvic organ prolapse or stress urinary incontinence.
So how was the transvaginal mesh actually approved?
The FDA compared the mesh to the kind of mesh already in use to treat abdominal wall defects and hernias. It was approved for sale through this 510(k) process. A lot of transvaginal mesh products on the market today are based on Boston Scientific Corp.’s ProteGen mesh original ProteGen design. Through the 510(k) process, FDA approved 168 transvaginal mesh devices as of 2010.
Research into the safety of these transvaginal mesh implant devices shows that that complications with these medical devices occurs in 10% of patients within a year of surgery. However, independent researchers have estimated that as many as 25% of patients suffer significant complications from the implantation of surgical mesh.
Complications associated with transvaginal mesh include:
- Erosion of the vaginal tissue
- Urinary problems such as incontinence
- Pain during sexual intercourse (dyspareunia)
- Organ perforation (puncturing) from surgical tools during mesh implantation
- Return of POP
- Neuro-muscular problems
- Vaginal scarring/shrinkage
- Emotional problems
The FDA first warned health care providers in 2008 about complications associated with the use of transvaginal mesh. Over 1,000 reports of complications from nine surgical mesh manufacturers came into the FDA. Many researchers have voiced their concern over the lack of safety data to justify performing surgical procedures on patients using transvaginal mesh. One of the main concerns is simply because of the 501(k) process.
Patients who suffer complications from the implantation of surgical mesh often need to undergo additional surgeries to remove the mesh and to repair any damage the mesh has caused.
Because of the problems associated with this transvaginal mesh implant device, concern over the FDA’s 510(k) process has grown. The Institute of Medicine released a report on July 29, 2011 called “Medical Devices and the Public’s Health: The FDA 510(k) Clearance Process at 35 Years.” The article called for the 510(k) process to be eliminated as it is not designed to evaluate the safety and effectiveness of medical devices. In this article, the FDA was urged to require device makers to prove that their device is safe and effective. Now there are several thousand lawsuits pending involving transvaginal mesh.
If you have had a transvaginal mesh implantation and have questions, please feel free to contact our attorneys