(PRWEB) November 16, 2012
The Food and Drug Administration is reporting that many women who have undergone operations for the conditions known as pelvic organ prolapse (POP) and urinary incontinence have suffered severe side effects that raise questions about the safety of transvaginal mesh implants.
The lawyers at Resource4thePeople want these women to know that these side effects have been reported in such increasing numbers to the FDA that the agency has issued warnings about these problems to physicians and patients.This report and warning are contained in a July 13, 2011 health alert:
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm262435.htm (See highlights below.)
Our team of transvaginal mesh lawyers point out that there has been a long history of devastating side effects associated with transvaginal mesh and that various models have been the subject of recalls and significant numbers of transvaginal mesh lawsuits.
The volume of these lawsuits has caused the federal court system to consolidate them into groups of what are called multi-district litigations that are overseen by judges for pre-trial evidence-gathering. (U.S. District Court, Southern District of West Virginia: MDL2325, MDL2326 and MDL2327.) These side effects, which were documented in the July 13, 2011 health alert issued by the FDA, are now contained in transvaginal mesh lawsuits that will have to be proven in court.
Women who have suffered these problems are being advised by Resource4thePeople to report them to their physicians and to take steps to preserve whatever legal options may be available to them to be compensated for medical costs, loss of wages, loss of consortium, pain and suffering and other expenses caused by their condition.
They are also advised to familiarize themselves with the history of complaints filed with the FDA involving products produced by such companies as DePuy, Biomet, Stryker, Rejuvenate and Prefemur.
At first the FDA responded to these "adverse events" reports from transvaginal mesh as an "area of continuing serious concern." However, as more transvaginal mesh problems were reported and more victims filed lawsuits the seriousness of these dangerous side effects were significantly upgraded.
In its most recent warning (http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm262435.htm) the agency said:
"The FDA is issuing this update to inform you that serious complications associated with surgical mesh for transvaginal repair of POP are not rare. This is a change from what the FDA previously reported on Oct. 20, 2008. Furthermore, it is not clear that transvaginal POP repair with mesh is more effective than traditional non-mesh repair in all patients with POP and it may expose patients to greater risk. This Safety Communication provides updated recommendations for health care providers and patients and updates the FDA’s activities involving surgical mesh for the transvaginal repair of POP."
So, what are these complications? The lawyers for Resource4thePeople have found the following to be the most common complaints, according to FDA data:
- Severe emotional problems
- Erosion of the transvaginal mesh
- Perforation of organs
- Recurrent pain
- Abdominal pain
- Vaginal pain
- Vaginal scarring
- Vaginal shrinkage
- Pain during sexual intercourse
- Urinary problems
- Recurrent POP
- Recurrent urinary incontinence
- Neuro-muscular problems
The FDA said that its statistics show that the most reported problem was mesh erosion and that in many cases women underwent second operations. Even such repairs are not always successful and some victims face the devastating reality that their organs will never be the same, according to the federal agency.
So what are POP and urinary incontinence? These are conditions common to many women who, as they age, suffer muscle weakening in their abdominal area. Sadly, some abdominal organs then droop and can drop into and out of the vagina.
This is not an uncommon problem for women. Approximately 200,000 operations are performed yearly in the United States for POP, according to the National Association for Continence. Urinary incontinence involves the uncontrollable release of urine, particularly during incidents of physical exercise, coughing, laughing or sneezing.
Surgeons use transvaginal mesh, an artificial substance that is usually polyester, by implanting it in the patient in order to reverse the droop and buttress the abdominal walls.
Unfortunately, as documented by the FDA, a substantial number of these transvaginal mesh implants have caused serious complications, severely affecting the health of thousands of women.
Resource4thePeople attorneys, who are still offering free consultations to transvaginal mesh victims, note that the allegations in these transvaginal mesh lawsuits mirror the concerns raised by the FDA in the same July 13, 2011 warning http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm262435.htm about transvaginal mesh complications.
In that warning to patients and health care professionals, the FDA said:
- Mesh used in transvaginal POP repair introduces risks not present in traditional non-mesh surgery for POP repair.
- Mesh placed abdominally for POP repair appears to result in lower rates of mesh complications compared to transvaginal POP surgery with mesh.
- There is no evidence that transvaginal repair to support the top of the vagina (apical repair) or the back wall of the vagina (posterior repair) with mesh provides any added benefit compared to traditional surgery without mesh.
- While transvaginal surgical repair to correct weakened tissue between the bladder and vagina (anterior repair) with mesh augmentation may provide an anatomic benefit compared to traditional POP repair without mesh, this anatomic benefit may not result in better symptomatic results.
- The FDA found that erosion of mesh through the vagina is the most common and consistently reported mesh-related complication from transvaginal POP surgeries using mesh. Mesh erosion can require multiple surgeries to repair and can be debilitating for some women. In some cases, even multiple surgeries will not resolve the complication.
The legal team at Resource4thePeople is an experienced, aggressive group that has a proven record in representing victims of defective drugs and defective medical devices. These transvaginal mesh lawsuits seek to hold the manufacturers of devices that are found to be defective or inadequately tested responsible for the health problems inflicted upon mesh victims.