Commentary: Why The Pelvic Surgical Mesh Debacle Is The Latest Example Of FDA’s Inability To Protect Consumers

Today, the FDA is meeting with its obstetric and gynecologic medical devices “advisory committee” to “help” the Agency decide the fate of surgical mesh devices commonly used in pelvic surgery on women, including procedures to remedy vaginal prolapse and urinary incontinence. The committee is supposed to be a group of outside “experts,” including a “consumer representative,” who will make non-binding recommendations to regulators concerning mesh products. “Good government” in action? No.

The Regulatory System

Medical devices such as surgical mesh are regulated by FDA pursuant to laws passed by Congress. Far and away, the most important of these laws is the Medical Device Amendments of 1976 (“MDA”). The MDA was intended to enhance FDA’s ability to ensure the safety and effectiveness of medical devices in much the same way as the FDA regulates drugs. Congress’ intent was to include requirements for robust pre-market testing of medical devices before they were allowed on the market in order to determine whether there are safety concerns.

Unfortunately, the intent of Congress in passing the MDA has been largely circumvented by a series of regulations promulgated by FDA ostensibly designed to “implement” the MDA. Ironically, these regulations, and one in particular, actually gutted the intended requirement of pre-market approval for the vast majority of medical devices on the market today.

Instead of having a single path to FDA marketing approval, as is the case for prescription drugs, medical device manufacturers may sell many types of products without any FDA approval at all. How can this be? FDA doesn’t have a lot of it, and manufacturers want to make more of it.

When the MDA was passed in 1976, there already existed thousands of medical devices on the market. FDA reasoned that it couldn’t possibly require all of these devices to undergo a new approval process—the Agency simply did not have the time or the financial resources. So, FDA decided to “grandfather” these products, meaning that they would get a “pass” and would not have to undergo the MDA pre-market review process.

Next, FDA had to consider proposed “new” devices. Many devices developed after 1976 were similar in design and purpose to grandfathered devices. FDA reasoned that it would be unfair to give the manufacturers of grandfathered devices a competitive advantage by requiring similar non-grandfathered products to undergo strict testing and approval standards when the older products were exempt. The “510K” process was born.

“510K” refers to the MDA statutory provision from which FDA granted itself the authority to make exceptions for post-1976 medical devices that the Agency deemed “substantially equivalent” to older products. Essentially, the process works like this: if a manufacturer wants to market a new medical device that falls into a category FDA deems is of “low risk” (e.g., surgical mesh), that product can be marketed without the usual pre-market testing and without formal FDA approval so long as the manufacturer can show that the device is relatively close in design and intended use to a product that is already being marketed. That is so even if the “old” product was itself never tested or approved by FDA. What’s worse is that, as it happened, the vast majority of products introduced to the market since 1976 have fallen into this 510K “loophole,” so that most medical devices sold today have never been tested in compliance with the pre-market testing requirements of the MDA, nor have they been formally “approved” by FDA.

The Pelvic Surgical Mesh Debacle

Since the 1950s, surgical mesh has been used to repair abdominal hernias. In the 1970s, gynecologists began using surgical mesh products indicated for hernia repair for abdominal repair of POP, and in the 1990s, gynecologists began using surgical mesh for surgical treatment of SUI and vaginal repair of POP. To do so, surgeons would cut the mesh to the desired shape for SUI repair or POP repair and then place the mesh through a corresponding incision. Over time, manufacturers responded to this clinical practice by developing mesh products specifically designed for SUI and POP repair.

Surgical mesh was a pre-MDA device and was classified after 1976 as a low to moderate risk product by FDA, meaning that old mesh devices were “grandfathered” past MDA pre-market requirements and “new” mesh devices got to take advantage of the less stringent 510K process.

The FDA cleared 85 mesh devices from 1992 through 2010. Major players in this market are Johnson and Johnson, Bard, Mentor, American Medical Systems and Boston Scientific. It is estimated that in 2010 alone 300,000 women underwent surgical procedures to repair Pelvic Organ Prolapse (POP). Over the next few years, surgical mesh products became more complex and evolved into “kits” that included tools to aid in the delivery/insertion of the mesh. The first kit for SUI repair, the Island Biosurgical Bladder Neck Suspension Kit manufactured by Island Biosurgical, Inc., was cleared in 1997. The first kits for POP repair, the AMS Apogee™ System and the AMS Perigee™ System, both manufactured by American Medical Systems, Inc., were cleared in 2004. Surgical mesh kits continue to evolve in regards to introducer instrumentation, tissue fixation anchors, surgical technique, and incorporation of absorbable materials into the mesh intended to increase material compliance.

The key is that even though these newer mesh products were used for purposes other than those of predecessor devices, and even as they became infinitely more complex and likely to result in complications, manufacturers were not required to conduct intensive pre-market testing or clinical trials to ensure safety. As the FDA recently noted, “The FDA [510K] process did not request original clinical studies to support clearance of surgical mesh indicated for treatment of SUI or POP.”

As the result of vaginal mesh products being exempt from the pre-market approval requirements of the MDA, adequate information about potential complications was not developed until after the products were on the market and in use for a substantial period of time. In essence, American patients were used as human guinea pigs in place of well-controlled pre-market clinical trials. FDA simply hoped, as it does with all 510K products, that they would remain “low risk.” Such was not to be the case for vaginal mesh.

As recently reported by FDA, between January 2008 through December 2010, the Agency received one thousand five hundred and three (1503) reports of serious complications in patients who had vaginal mesh products implanted. These devices had been surgically implanted in women who were suffering from Pelvic Organ Prolapse. Typically, women who suffer from this condition have had several children and their pelvic anatomy has been compromised. The devices act like a sling or hammock and replace a woman’s natural musculature.

These mesh devices are made primarily of polypropylene. Evolving scientific evidence demonstrates how this synthetic material reacts after being implanted in the human body, and it is now believed in many corners of the medical community that these devices erode and sometimes disintegrate into many tiny pieces. Once the device’s integrity is lost, these pieces migrate and sometimes penetrate the woman’s urethra, vagina or bladder. Once this occurs, most women are in for a long, painful and often tragic course that includes multiple surgeries, infections and loss of normal bladder and sexual function.

FDA now clearly sees a need to more aggressively regulate pelvic mesh devices. It’s about time. Unfortunately, because these devices were subject to the 510K process, FDA’s options are limited and politically unpalatable. FDA faces strong opposition from industry and certain segments of the medical community with respect to any strict new safety requirements. FDA is obviously using its advisory committee to provide a measure of political cover in the hopes that recommendations from a group of “objective” scientists will give it the impetus to force new safety requirements, up to and including a reclassification of mesh products so that they must undergo pre-market approval, as opposed to 510K clearance.

The Bigger Picture

Unfortunately, this is not the first occasion in which 510K “cleared” medical devices have proven to be public health threats. There have been numerous recalls of such products ranging from contact lens cleaners to spinal surgery devices to cardiovascular products. The list grows every day.

The process by which this country assures the safety and efficacy of medical devices has been called “broken.” In a recent report issued by the National Academy of Science’s Institute of Medicine, a “blue-ribbon” panel of medical and regulatory experts concluded that “the 510(k) program lacks the statutory basis to make it a reliable premarket screen for safety and effectiveness of [certain] medical devices.” The IMO report went on to note that “the 510(k) clearance process is not intended to evaluate the safety and effectiveness of medical devices with some exceptions. The 510(k) process cannot be transformed into a premarket evaluation of safety and effectiveness as long as the standard for clearance is substantial equivalence to any previously cleared device.”

If the FDA can’t adequately protect consumers, who can? Traditionally, the civil tort law system, whereby injured consumers can sue manufacturers under products liability law, has provided an important safety net around inadequate and underfunded regulatory systems. However, even as FDA grows increasingly incapable of guarantying the safety and effectiveness of the Nation’s drugs and medical devices, the health care products industry has worked tirelessly to implement “tort reform” in many states which has drastically reduced the ability of injured people to seek redress in the courts. Of more concern is the growing tactic used by drug and device makers to argue that FDA regulations–the same regulations which the FDA and IOM acknowledge are inadequate—should “preempt” the ability of citizens to bring products liability cases. Unfortunately, a number of courts throughout the country have bought into the preemption “illusion,” which argues at its core that regulation of these industries should be left to the federal government. Good luck with that.

Do I Have a Transvaginal Mesh Lawsuit?

The trial lawyers at The Senators (Ret.) Firm, LLP have decades of experience navigating through complex legislative and regulatory issues and litigating high stakes cases all over the nation. Our law firm focuses on the representation of plaintiffs in transvaginal mesh lawsuits. We are currently accepting new cases in all 50 states.

Again, if you or a loved one has been injured by transvaginal mesh, you should contact our lawyers immediately by clicking the link below or calling toll free 1-(949) 557-5800. You may be entitled to compensation for your injuries and we can help.