Surgical Mesh FDA Warnings - Early Warnings

In October of 2008 the FDA sent letters to surgeons and medical professionals advising them on the potential side effects of Surgical Mesh Devices. At that time the FDA declared these complications to be "rare". The FDA stated from 2005 through 2008 they recieved over 1,000 reports from nine different surgical mesh manufacturers that complications were associated with Surgical Mesh devices. The complications listed by the FDA included erosion through vaginal epithelium, infection, pain, urinary problems, and recurrence of prolapse and/or incontinence. Some cases mesh erosion led to "a significant decrease in the patient quality of life."Surgical Mesh devices were cleared under what's called the FDA's 510(K) process. The 510(K) process allows products to be approved without extensive studies if the product "substantially equivalent" to other products in the market.

FDA Status Update of Surgical Mesh Devices

On July 13th the FDA sent an update on Mesh Devices titled "UPDATE on Serious Complications Associated with Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse." In this update the FDA alerts health care providers on the increasing risks of using Surgical Mesh devices. In this update the status of serious complications from Surgical Mesh devices is "not rare." The FDA Surgical Mesh update reads

Based on an updated analysis of adverse events reported to the FDA and complications described in the scientific literature, the FDA identified surgical mesh for transvaginal repair of POP as an area of continuing serious concern. The FDA is issuing this update to inform you that serious complications associated with surgical mesh for transvaginal repair of POP are not rare.

The FDA continues to state the most common complication or side effect from Mesh products is the erosion of the mesh through the vagina, pain, infections, bleeding urinary problems, vaginal scaring and emotional problems. The FDA conducted a "systematic review" of Mesh devices from 1996 to 2011. The FDA learned the most common and reported side effect is erosion of the mesh. Multiple surgeries are required to repair the erosion which can be demilitating for some woman. In some cases the erosion of surgical mesh devices can not be repaired severely impacting the patients quality of life.

These finding by the FDA on the complications of Surgical Mesh devices can not be tied to a single brand of surgical mesh.

FDA to Classify Surgical Mesh Devices as "High Risk?"

Next week the FDA is meeting to determine if Surgical Mesh Devices will be moved to the "High Risk" category. On Sept 8th The FDA’s Obstetrics-Gynecology Devices Panel of the Medical Device Advisory Committee will meet to discuss the category changes to Surgical Mesh Devices. According to the FDA website this meeting topic will be:

On September 8 and 9, 2011, the committee will discuss and make recommendations regarding the safety and effectiveness of transvaginal surgical mesh used for repair of pelvic organ prolapse.  FDA is convening this meeting to seek expert opinion on the risks and benefits of these devices in light of adverse events, e.g., vaginal erosion leading to pelvic pain and dyspareunia, and available information on clinical benefit. 

Should the FDA classify Surgical Mesh Devices as high risks, manufacturers of these products will be required to conduct post market studies and give that data to regulators for regular review. It is noted that the FDA received over 1,500 reports of complications from surgical mesh devices from 2008 to 2010. Patient groups like Public Citizen have petitioned the FDA to recall Surgical Mesh Devices.

Surgical Mesh Devices Claims and Lawsuit

First if you have suffered any of the symptoms from your Surgical Mesh device, immediately contact your doctor. Also, if you have been adversely effected from a Surgical Mesh device you may be entitled to compensation. To have your Surgical Mesh claim evaluated by an attorney, complete our Surgical Mesh Claims Form.

Surgical Mesh Lawsuit Information: If you have suffered injury as a result of Surgical Mesh, you should consult an Surgical Mesh Claims lawyer as soon as possible in order to protect your claim for a Surgical Mesh Device Lawsuit and settlement.