Vaginal Mesh Implant Lawsuit

 

If you have received a transvaginal mesh implant, you might be at risk.

The Food and Drug Administration, FDA, has issued a warning regarding the risks involved in using surgical mesh implants, which are used to treat cases of pelvic organ prolapse. About 1,503 adverse event cases related to the vaginal placement of mesh have been reported to the FDA between 2008 and 2010. The FDA warning says that the risks outweigh the benefits of mesh implants, which are permanently implanted vaginally or abdominally to reinforce the vaginal tissue or wall.

The FDA review, carried out from 1996 to 2010, found that mesh implants used in transvaginal pelvic organ prolapsed repair posed a greater risk of pain, bleeding, and infection to the patient. Besides, women with such implants might even be forced to undergo additional surgeries or hospitalization.

Studies comparing mesh surgeries to non-mesh surgeries conducted between 1996 and 2010 have found that the number of adverse events has been constantly rising. Following the review, the FDA suggested that many patients having undergone transvaginal mesh implant surgery were exposed to additional risks compared to patients opting for POP repair with stitches. The first safety warning about the mesh implants came up in 2008 following increasing concerns about adverse events.

The federal body has received numerous complaints of adverse events associated with mesh implants, which include pain, bleeding, infection, erosion through the vaginal tissue, pain during sexual intercourse, urinary problems, and organ perforation from surgical equipment.

The latest FDA warning says patients undergoing surgery for pelvic organ prolapse are at a greater risk than other surgical procedures. Further, the FDA has not found any improvement in the quality of life of patients who had undergone implantation of surgical mesh.

Patients have complained that they experience sparking constant pain around the area and have to undergo a number of surgeries to remove the mesh that eroded in their vagina. The FDA has not ruled out “serious complications” in some cases. According to the federal agency, nearly half of all women

who have undergone mesh implant surgery might be affected during their lifetime.

 


FDA Device Approval Process in Question


There are widespread concerns about the government procedure that gives approval to such devices made of the material used for making Rubbermaid storage containers. Also, reports claim that there is no testing of the devices on humans before these enter the market for sale.


Questions have been popping up as to how the FDA clears thousands of such devices for the market. A recent study published in the journal Archives of Internal Medicine conducted on the latest recalls examined 113 recalls of the products deemed serious for health by the federal agency, from the beginning of 2005 to the end of 2009. The study found that only 21 devices were required to undergo prior testing on patients before receiving marketing approval.


The study also found that manufacturers of 80 of the products recalled later had easily exploited FDA’s 510(k) approval process by showing the federal body that their devices were akin to products already on the market. The review panel also found that remaining eight recalled devices were not required to go through any kind of FDA review.


A growing number of complaints of complications reported in patients, who have had surgical mesh implanted, have spurred the FDA to issue a second warning three years after the first one about the device. The FDA plans to convene a panel to seek advice whether mesh implants deserve to undergo more rigorous testing. Most medical devices do not to undergo testing prior to being released in the market, and mesh implants belong to this category of devices. In fact, the FDA has declared that about 10 percent of such devices are the riskiest, including implantable pacemakers and breast implants.


An outside panel of obstetrics and gynecology experts will meet from September 8th to September 9th to discuss the efficacy, safety, and risks of mesh implant surgery and transvaginal POP repair.


What is Pelvic Organ Prolapse


POP is a condition in which the tissues meant for supporting the pelvic organs, including uterus, bladder, rectum, and bowel, become so weak that they are misplaced from their original position and prolapse into the vagina. Women suffering from pelvic organ prolapse often experience discomfort in the pelvic area, disruption of important bodily functions, including urinary, sexual, defecatory, physical weakness, and reduction in quality of life. Doctors began using surgical mesh to correct the anatomy and thus support pelvic organs that had slipped over time.


According to the FDA, there’s is lack of evidence to support that transvaginal surgical mesh brings any positive change in the life of the patient. Through a review of scientific articles published for the past 15 years, the FDA declared that use of the mesh does not provide relief from symptoms or improve quality of life in any way, especially when compared to traditional treatment for pelvic organ prolapse.


A study conducted on 65 women published in the journal Obstetrics & Gynecology last year questioned the value of mesh implants used to treat pelvic organ prolapse. The research found that mesh had eroded in one in six women after three months of surgery.  The study did not find any change in the quality of life or cure rates between the mesh and no-mesh groups, leading the researchers to question the value of the device in such procedures.