Surgical Procedures Using Mesh
Mesh has been widely used in a variety of surgeries since the 1950’s, and was originally approved for use in abdominal hernia surgery. Surgeons began altering the size and shape of the mesh devices, using them in women’s surgeries for pelvic organ prolapse and stress urinary incontinence. It was not until 1996 that the mesh was approved specifically for SUI surgeries and 2002 when it was approved for POP surgeries.
Mesh Complications
The FDA issued their first public health alert in 2008 detailing the potentially serious complications associated with the transvaginal placement of surgical mesh when used to repair pelvic organ prolapse or stress urinary incontinence. The agency then updated the original warnings stating that mesh complications in transvaginal repair of pelvic organ prolapse were actually not all that rare. They continued the warning by stating that when compared to traditional, non-mesh repairs for pelvic organ prolapse, there are no apparent benefits to using mesh.
To date, the FDA has received as many as 4,000 reports of serious complications associated with the mesh implant, particularly when used in the transvaginal repair of pelvic organ prolapse. These reported complications cover the period from January, 2005 through December, 2010, with almost three-fourths of those in the past three years. Many believe the numbers will continue to climb; a 2009 review in the International Urogynecology Journal stated the complication rate from use of vaginal mesh was from 7%-25% with those who smoked increasing that already high risk of complications as much as three times.
Clinical Trial Stopped
Following the FDA’s warnings, a 2010 clinical trial which compared traditional surgical procedures used in repairing pelvic organ prolapse to transvaginal mesh procedures was halted before completion due to complications in over 15% of the patients whose surgery included mesh. The primary complication was mesh erosion, a serious and even potentially fatal medical injury which typically requires one or more surgeries to correct and repair. Regarding this study one of the lead authors of the report stated that in the end not only were there more complications, but the mesh didn’t prove to work any better than traditional surgery.
Is Inappropriate Selection of Patients an Issue in Mesh Damages?
Some believe that one of the primary problems in the mesh controversy is the criteria used to select patients for the transvaginal mesh surgery which repairs pelvic organ prolapse. Because the mesh device seemed so promising for women suffering from pelvic organ prolapse it may have been inappropriately used for younger, active women who could have received greater benefits from alternative types of non-vaginal surgery. Mesh surgeries are more appropriate for use in older, less sexually active women who either cannot undergo abdominal surgery or who has suffered a recurrent prolapse after a past surgery.
Approval for J & J Mesh Based on Recalled Device
The 2008 FDA warning regarding complications associated with transvaginal placement of mesh included specifics regarding the Bard Avaulta mesh product. C.R. Bard, Inc., the makers of the Bard Avaulta mesh, sent out a recall of the mesh in 2005, urging physicians to stop using specific versions of the product which could potentially break and cut through internal organs and tissues. The recalled device, known as the Kugel patch, created a storm of controversy when some Bard executives said they knew about serious injuries which were potentially caused by the device. Several fatalities were even believed to be potentially related to use of the Kugel patch. C.R. Bard maintained they acted responsibly, however FDA officials found discrepancies and inconsistencies in the manner in which the devices were traced and analyzed.
Is “Substantially Equivalent” Good Enough?
Even though the Kugel patch was recalled, Johnson and Johnson subsequently gained approval for their own mesh device based on its precursor—the Kugel patch. Approvals of medical devices based on an assessment that they were “substantially equivalent” to a previously approved device may be one flaw in the system which has allowed a potentially harmful device to be implanted in thousands of women. Johnson and Johnson’s approval from the FDA for their vaginal patch was predicated on the claim they were substantially similar to the recalled Kugel patch—presumably without the design flaws. Currently Johnson and Johnson has at least 600 vaginal mesh lawsuits in the works against the giant corporation; when you consider that as thousands of women received vaginal mesh implants in the past year alone, those numbers are expected to grow.
Transvaginal Mesh Applications Declared “Experimental” in 2007
In February of 2007—prior to the FDA’s public health alert in 2008—the American College of Obstetricians and Gynecologists issued a bulletin on pelvic organ prolapse. This bulletin warned both physicians and their patients to consider the vaginal mesh procedure to be experimental, and that patients who consented to the procedure should be made aware of that fact. They went on to say that because there was both limited data as well as frequent changes in the mesh products which were being marketed—particularly regarding the material the mesh was constructed from—that women considering having the mesh surgery should be aware of the potential risks and complications.
Some seven months later, the same group issued a second bulletin with a much softer warning, and with the word “experimental” mysteriously gone. In this bulletin women were only warned that because of the limited data and changes in marketed products as well as potential mesh erosion, patients should only consent to surgery with this understanding. Because “experimental” procedures are rarely covered by insurance, it has been speculated that the potential of losing large amounts of money resulted in the change in wording.
Is a Flawed Approval System to Blame for Mesh Complications?
Although the current FDA approval system has been in place for over three decades, the Institute of Medicine—for one—believes the government should abandon this medical device approval system because it offers little safety assurance for patients. The medical device industry is currently a $350 billion dollar industry which covers everything from pacemakers to contact lenses. Although this advice is not binding upon the FDA, it could prove that Americans want tighter standards for medical device manufacturers who have benefitted financially from less safety scrutiny than their peers in the industry. Most new prescription drugs are required to go through rigorous clinical trials to prove definitively that patients benefit from the medication—and that there are no serious side effects. On the flip side, most medical devices, including mesh, must only show they are similar to a device which is already on the market. It is only the truly brand new innovations which are required to undergo safety testing. The FDA defends the system in place stating they have been working for over a year to make the approval process for medical devices more predictable and less bureaucratic—changes which would be scrapped if the entire system is revamped.
Does the 510(k) Approval System Need an Overhaul?
This 35-year old process, known as the 510(k) process has some wondering if it really protects Americans to the fullest extent possible. While the FDA is not in favor of eliminating the procedure, they are open to proposals for improvement. FDA officials point out that they are already subject to criticism from manufacturers of medical devices who believe the agency is too slow in clearing new devices, driving up costs and even forcing smaller companies out of business. The 510(k) system was created by Congress in 1976 with a goal of granting quicker approvals to devices which were substantially similar to medical devices already on the market.
The system was originally intended to be a temporary means of grandfathering in medical devices which had been used for decades however over time became the standard in launching new medical devices. Today, nearly 4,000 devices are cleared each year under the present 510(k) system while only around 50 devices are approved under a more stringent system of human testing. While the 510(k) system is not considered inherently unsafe, there must be more safeguards in place to protect patients from harm. Although the FDA is battling a multi-million dollar lobbying effort by medical device manufacturers, they may have a stronger position due to the fact that reports of pain, bleeding and infection with the mesh implants are up 500 percent since 2008.
Class II vs. Class III
Prior to the convening of the September 8th panel regarding the adverse reports of the transvaginal mesh implant, the FDA recommended that transvaginal mesh products be reclassified to a Class III (high risk) rather than their current Class II (moderate risk). A Class II device is approval under the abbreviated 510(k) process while a Class III classification would give the FDA stronger controls over the clinical studies conducted before marketing the product. Obviously the mesh industry wants to maintain their Class II status, arguing that additional studies and labeling changes on mesh implants are sufficient to safeguard the health of women. Re-classifying the mesh implants as high risk would require them to undergo approval of manufacturing procedures, inspections of their device plans and a longer review period.
The FDA must sort through the dizzying array of opinions and facts regarding the safety, efficacy and potential reclassification of the transvaginal mesh implants and must also make critical decisions regarding further clinical studies prior to making their final determination. In the meantime a national group of surgeon’s stated the transvaginal mesh devices should only be used in a limited number of carefully chosen women, and only by highly trained physicians in the procedure. While Johnson and Johnson continues to maintain that its vaginal mesh product is safe, women must become their own health advocates and make sure they have all the facts before agreeing to a transvaginal mesh procedure. Women who have suffered severe complications as a result of a mesh implant may face multiple surgeries and may never fully recover from the damage done. As we wait for a decision from the FDA, it is likely that more women will be coming forward regarding the damage done by a mesh implant.