Legislation was passed in February allowing the FDA to reject devices that were designed based on products recalled for safety flaws in the past. In many cases, the FDA lacks proper authority, which takes away from the credibility of some device approvals, according to Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health.
Shuren added, “It’s good for patients and it’s good for companies and it assures that if there’s a problem with the new device, it gets addressed before it goes to market. The challenge now is if there’s a problem, it can get replicated” through future generations of devices.”
On average, the FDA clears close to 30 devices that cite a predicate known to be recalled each year, according to Shuren. Some of these devices include high-profile failures such as vaginal mesh, which shakes consumer faith.
In July of 2011, MedWatch, the FDA Safety Information and Adverse Event Reporting Program, released a safety update stating that “serious complications associated with surgical mesh for transvaginal repair of POP (Pelvic organprolapse) are not rare.” The safety communication also noted that this information is a change from what the FDA reported in 2008.
In 2011, the FDA announced that almost 3,000 complications associated with Vaginal mesh were reported. The most common of these complications include:
- Mesh erosion
- Dyspareunia (pain during sexual intercourse)
- Urinary problems
- Organ perforation
Contact a Medical Device Lawyer
Anyone who has experienced any of the risks associated with vaginal mesh may qualify for compensation to help with the cost of medical expenses as well as pain and suffering. To contact a Vaginal Mesh lawyer for a free consultation and Vaginal Mesh lawsuit information, call Matthews and Associates toll free at 1-888-520-5202 or fill out the contact form.