Part 2 - Suffering in Silence from a Medical Device - Surgical Mesh
IMAGE SOURCE: Surgical mesh, Nylon 66 top left, IVS top right, Soarc bottom left, TVT bottom right/ Int. Urogynecol. J. 2003, Web image
IMAGE SOURCE: (inset) Courtesy: Suzanne McClain
Background : As we reported in Part One of “Suffering in Silence” – Suzanne McClain had what she was told by her doctor would be a routine, simple surgery to correct stress urinary incontinence (SUI) experienced by about 13 million American woman. The condition causes urine leakage during laughing or coughing.
In 2008, a urogynecologist found the TVT mesh had invaded McClain’s vaginal wall, a side effect of the migrating synthetic mesh that an increasing number of women and men (for hernia repair) are experiencing. A surgeon was only able to extract about one-third of the mesh leaving behind the rest which had become enmeshed in her tissues.
An Angry Woman
Last year, when Suzanne McClain filed a complaint with the medical board against the surgeon who promised a safe and effective medical procedure to treat SUI without informing her of the side effects, his response in writing was that she was an “angry woman.”
Suzanne tells IB News she is still angry.
“I feel like I was used as a guinea pig and that my doctor, the manufacturer, and the FDA are all responsible; my doctor for non disclosure of possible complications, the manufacturer for allowing this device to remain on the market to harm other women despite the fact that numerous adverse events that are on file and continue to be reported to the FDA.”
And what makes her and others angrier is that the mesh embedded in their bodies never went through the premarket approval (PMA) process for safety most people assume has been conducted by the federal Food and Drug Administration, especially for a medical device to be implanted internally.
“Until hearing Suzanne's story, I did not know that products could be placed on the market without proper testing. I just assumed that all products that are FDA approved were tested. Bad assumption obviously” says Naomi writing to Part One of the story.
Proof of Safety and Efficacy May Not Be Required
The past president of the American Urogynecologic Society (AUGS), Dr. Donald Ostergard, delivered the keynote address to the annual meeting of AUGS in Palm Springs, California, October 2006.
Approval for new surgical implants such as mesh is different than those for a new medication he told the crowd. The proof of safety and efficacy may not be required.
It’s a little known loophole buried deep within the administrative jargon of the Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) which is responsible for overseeing medical devices.
The process is known as – 510(k) – and is designed to fast-track the marketing of low risk medical devices that fall under a Class I category such as latex gloves, wheelchairs, and tongue depressors, or Class II devices, such as a urological catheter, non-invasive blood glucose monitors, and surgical mesh.
The manufacturer of a Class I or II medical device provides a letter to convince the CDRH that the device is “substantially equivalent” to a legally marketed device already on the market known as a “predicate device”.
The application can be done quickly and through the mail, as seen in a letter in 2005 from the FDA to Gynecare concerning the TVT SECUR sling, “The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.” (italics by IB).
Essentially it's an approval for marketing, not an approval based on safety – that’s optional.
The FDA’s Bill Sutton, who directs the division of small manufacturers, tells IB News, “If the company provided a summary of safety and effectiveness that is the manufacturer's choice.”
“It’s very rare we rescind a 510(k)” says Sutton, referring to an option the FDA has to prohibit the manufacturer from marketing the 510(k) device. A voluntary recall can also be conducted, but that is at the company’s discretion.
With 3,600 510(k) applications a year, Sutton says, “Maybe two percent or one percent are not found to be substantially equivalent. Well over 90 percent are cleared by the 510(k) process.”
What Happens When The Predicate Device Is Withdrawn?
The history of urinary incontinence or pelvic organ prolapse mesh reads like a laundry list of “substantially equivalent” “predicate devices”.
In the early 1990s, the Vesica procedure was introduced to treat stress urinary incontinence (SUI). Vesica was a watershed event largely because the tape was delivered precut in a “surgical kit” marketed to doctors to turn synthetic surgical repair mesh into a billion dollar business.
The ProteGen sling (coated with bovine collagen) was approved in 1996 when device maker Boston Scientific claimed that ProteGen was “substantially equivalent” to the Vesica, which was now largely abandoned.
Suzanne was treated with Ethicon’s (Johnson & Johnson) Transvaginal (Tension-Free) Surgical mesh, which was predicated on the Boston Scientific ProteGen Sling.
Yet in March 1999, 14 months after the Ethicon TVT tape was approved, its predicate device – the ProteGen sling - was recalled from the market. The FDA said the ProteGen Sling was “adulterated and misbranded” and leading to problems such as vaginal erosion or dehiscence and did not appear to function as intended.
At least 1 class action lawsuit resulted charging device maker Boston Scientific with defective design, failure to warn, negligent training of physicians, fraudulent concealment, Fraud on the FDA, misrepresentation, and breach of warranty among other claims.
“It defies logic,” says Suzanne McClain in a letter to InjuryBoard, “Common sense should have dictated that all devices that had received approval using the ProteGen Sling as their predicate device would too have been pulled from the market.”
“It’s not a regulatory requirement to do so” says Siobhan DeLancey, press officer for the Center for Devices and Radiological Health (CDRH) to IB News. “We have an informal policy, if the predicate was withdrawn because of manufacturing, not specifications itself, then we may not look at 510(k) device. It’s kind of a case by case basis.”
Industry Acknowledges The Problem
Writing in OBG Management, March 2009, Dr. Anne Weber who sees the Ethicon TVT mesh as an improvement upon the other meshes, is concerned about the assumption of safety.
“Nevertheless, I am concerned that some clinicians do not appear to appreciate the true lack of evidence that accompanies most marketed devices for prolapse and incontinence. They may mistake the FDA 510(k) process of clearance for something similar to the agency’s extended and complex drug approval process. They may accept claims made in industry-produced white papers that are often largely promotional materials, and fail to look further into those claims.”
“Since these products are being widely used and successfully marketed with scant published data, there is very little commercial incentive to publish results,” the American Urogynecological Society (AUGS) says in its review of its 27th Annual Scientific Meeting.
Audience member Dr. Matt Barber noted: "We are chasing a moving target," noting that new products are introduced faster than they can be evaluated, then taken off the market, modified somewhat, then reintroduced.
For example, doctors looking for any medical literature on the ProteGen sling wouldn’t find any until after market withdrawal. Surgeons using the ProteGen from 1997 to 1999 did so without any published scientific endorsements.
“Without adequate information, the possibility that associated problems will not be identified until a new device has been used on hundred or possibly thousands of women is significantly increased,” concludes the AUGS meeting.
Estimates are that over 2,000 women receive some type of pelvic organ prolapse support implants each month, “despite a paucity of published safety and efficacy data” the organization admits.
McClain is no longer suffering in silence. She and other members of the patient advocacy group, Truth In Medicine are calling for Congressional hearings.
“How many more women have to be harmed before the FDA does their job and issues a recall?" she asks.
(Continue reading: Suffering in Silence - Part 3- Doctors Weigh In On Surgical Mesh). #