Transvaginal or pelvic mesh was not approved by the FDA in any proper fashion, which would require rigorous safety testing. Johnson & Johnson and the makers of other pelvic mesh products – meant to treat pelvic organ prolapse or stress urinary incontinence – slipped their products past the FDA under the aegis of the 510(k) clearance process. This 510(k) process has stirred much controversy.
FDA’s 510(k) Clearance Process
The FDA’s 510(k) clearance process allows the agency to give a medical device – such as a transvaginal/pelvic mesh or an obesity balloon – a free pass from the usual rigorous testing required for medical devices. All a device maker need do for new device approval under 510(k) is claim that its device is substantially equivalent to a “predicate” product already on the market, so long as that new product is not considered life sustaining or life supporting. (More on that below.)
Related: Obesity Balloon Lawsuit
Predicate Mesh Product was Recalled
Nearly every synthetic mesh device now on the market was cleared through the 510(k) process based on the predicate product of Boston Scientific’s ProteGen mesh, even though BSC recalled ProteGen in 1999, less than three years after it hit the market.
The precursor material for most meshes is heavyweight plastic hernia mesh first used in the 1970’s. Johnson & Johnson and Janssen and other mesh makers claimed their transvaginal meshes were substantially equivalent to the recalled BSC mesh, and the FDA allowed that reasoning.
Experiments on Women with 510(k) Mesh
Many women are shocked and saddened to learn that the plastic mesh sewn into them never underwent any significant clinical testing or medical trials. Since the 1990’s, mesh makers have used the federal 510(k) loophole in FDA rules which allows fast, easy approval for untested devices.
Pelvic Mesh not approved by FDA – 510(k) Controversy
More than 90 percent of all medical devices implanted in the U.S., including ALL women’s pelvic mesh devices, are “reviewed” using the FDA’s 510(k) pre-market notification process. This virtually painless (for corporations) process began in 1976 as part of the federal Food, Drug and Cosmetic Act. The 510(k) process was supposed to be used only for simple devices that didn’t pose serious risk. But since that time, wild acceleration of technological “advancements” (a very subjective term given that the uncritical embrace of nearly every new “advance” does not prove that it IS an advance at all) in medical manufacturing have allowed for quickening production of increasingly sophisticated devices. Despite this acceleration of technological innovation and the near universal knee-jerk prejudice to embrace every “new and improved” technology as an “advancement” over the old (“old bad, new good” is the only apparent ethos for “modern living” where corporate profiteers are concerned), 510(k) clearance rules have remained unchanged.
510(k) Clearance Process
The 510(k) act established three regulatory classes:
- Class I – Devices which are not life sustaining or life supporting, hence subject to the least regulatory controls. Class I devices include bandages, enema kits.
- Class II – Devices not needed to sustain life, but necessary to support it. Class II devices – 40 percent of all devices – are not considered immediate risk. Pelvic Mesh is a Class II device.
- Class III – Devices which support life, such as implantable pacemakers, breast implants.
Class I and II devices are considered low-risk devices; consequently they allow their makers to seek clearance via the 510(k) process.
Submissions overwhelm FDA
The FDA Center for Devices and Radiological Health reviews some 4,000 510(k) submission each year. FDA reviewers – engineers, microbiologists, chemists, physicians – decide whether the proposed product meets 510(k) standards.
FDA requires that the product be “substantially equivalent” to an original product, known as the predicate device. The Medical Device User Fee and Modernization Act of 2002 further loosened (Read: weakened) the regulations to allow products made from similar materials, even though they might be using a different mechanism of action, to undergo 510(k) clearance.
To prove equivalence, and to save a lot of time and money in avoiding the regular approval process, the product maker must prove the new product has the same general intended use, along with the same design and materials as its predicate. This process does not usually require clinical studies or advance testing to prove safety and/or effectiveness. The process for Class II devices typically takes roughly 90 days, which is much faster than the process to approve a Class III device.
510(k) Criticisms, Changes
These weak clearance regulations, along with the growing problems with pelvic mesh and other 510(k)-cleared devices, have forced many medical experts to start asking for changes. Dr. Steven Nissen of the Cleveland Clinic recently reviewed 113 urgent recalls on several different devices from 2005 to 2009. Dr. Nissen found more than 70 percent of the recalled devices had been cleared through 510(k). The Institute of Medicine also recently released a report highly critical of the 510(k) process. ION called on FDA to set new guidelines for Class I and II approval. Medical device manufacturers have (of course) lashed back at the call for decent regulation. Mesh makers and other device makers have warned that any changes to the 510(k) process will threaten the device market and slow their steady stream of medical device miracles.
A Congressional bill introduced in 2012 to slow the 510(k) clearance process stalled. FDA announced in 2013 that it would make changes to the way some devices were approved, including the much troubled metal-on metal artificial hip implants.
Predicate Mesh Adulterated, Mis-branded
Because every transvaginal mesh device on the market today can trace its roots back to Boston Scientific’s ProteGen sling, we have a perfect example of how women’s pelvic mesh “innovation” was fraught with peril from the start. When Boston Scientific recalled the ProteGen after only three years, the company admitted: “[I]t did not appear to function as intended.” BSC said ProteGen had a high rate of erosion. The FDA, in addition, called the ProteGen “adulterated” and “mis-branded.” Nonetheless, because the device was withdrawn “voluntarily,” it has continued to be used as a predicate device for all subsequent transvaginal mesh devices.
Mesh Lawyers argue Pelvic Mesh not approved
Transvaginal or pelvic mesh was not approved by the FDA in any proper fashion, which would require rigorous safety testing. Johnson & Johnson and the makers of other pelvic mesh products – meant to treat pelvic organ prolapse or stress urinary incontinence – slipped their products past the FDA under the aegis of the 510(k) clearance process. This 510(k) process has stirred much controversy.
FDA’s 510(k) Clearance Process
The FDA’s 510(k) clearance process allows the agency to give a medical device – such as a transvaginal/pelvic mesh or an obesity balloon – a free pass from the usual rigorous testing required for medical devices. All a device maker need do for new device approval under 510(k) is claim that its device is substantially equivalent to a “predicate” product already on the market, so long as that new product is not considered life sustaining or life supporting. (More on that below.)
Related: Obesity Balloon Lawsuit
Predicate Mesh Product was Recalled
Nearly every synthetic mesh device now on the market was cleared through the 510(k) process based on the predicate product of Boston Scientific’s ProteGen mesh, even though BSC recalled ProteGen in 1999, less than three years after it hit the market.
The precursor material for most meshes is heavyweight plastic hernia mesh first used in the 1970’s. Johnson & Johnson and Janssen and other mesh makers claimed their transvaginal meshes were substantially equivalent to the recalled BSC mesh, and the FDA allowed that reasoning.
Experiments on Women with 510(k) Mesh
Many women are shocked and saddened to learn that the plastic mesh sewn into them never underwent any significant clinical testing or medical trials. Since the 1990’s, mesh makers have used the federal 510(k) loophole in FDA rules which allows fast, easy approval for untested devices.
Pelvic Mesh not approved by FDA – 510(k) Controversy
More than 90 percent of all medical devices implanted in the U.S., including ALL women’s pelvic mesh devices, are “reviewed” using the FDA’s 510(k) pre-market notification process. This virtually painless (for corporations) process began in 1976 as part of the federal Food, Drug and Cosmetic Act. The 510(k) process was supposed to be used only for simple devices that didn’t pose serious risk. But since that time, wild acceleration of technological “advancements” (a very subjective term given that the uncritical embrace of nearly every new “advance” does not prove that it IS an advance at all) in medical manufacturing have allowed for quickening production of increasingly sophisticated devices. Despite this acceleration of technological innovation and the near universal knee-jerk prejudice to embrace every “new and improved” technology as an “advancement” over the old (“old bad, new good” is the only apparent ethos for “modern living” where corporate profiteers are concerned), 510(k) clearance rules have remained unchanged.
510(k) Clearance Process
The 510(k) act established three regulatory classes:
- Class I – Devices which are not life sustaining or life supporting, hence subject to the least regulatory controls. Class I devices include bandages, enema kits.
- Class II – Devices not needed to sustain life, but necessary to support it. Class II devices – 40 percent of all devices – are not considered immediate risk. Pelvic Mesh is a Class II device.
- Class III – Devices which support life, such as implantable pacemakers, breast implants.
Class I and II devices are considered low-risk devices; consequently they allow their makers to seek clearance via the 510(k) process.
Submissions overwhelm FDA
The FDA Center for Devices and Radiological Health reviews some 4,000 510(k) submission each year. FDA reviewers – engineers, microbiologists, chemists, physicians – decide whether the proposed product meets 510(k) standards.
FDA requires that the product be “substantially equivalent” to an original product, known as the predicate device. The Medical Device User Fee and Modernization Act of 2002 further loosened (Read: weakened) the regulations to allow products made from similar materials, even though they might be using a different mechanism of action, to undergo 510(k) clearance.
To prove equivalence, and to save a lot of time and money in avoiding the regular approval process, the product maker must prove the new product has the same general intended use, along with the same design and materials as its predicate. This process does not usually require clinical studies or advance testing to prove safety and/or effectiveness. The process for Class II devices typically takes roughly 90 days, which is much faster than the process to approve a Class III device.
510(k) Criticisms, Changes
These weak clearance regulations, along with the growing problems with pelvic mesh and other 510(k)-cleared devices, have forced many medical experts to start asking for changes. Dr. Steven Nissen of the Cleveland Clinic recently reviewed 113 urgent recalls on several different devices from 2005 to 2009. Dr. Nissen found more than 70 percent of the recalled devices had been cleared through 510(k). The Institute of Medicine also recently released a report highly critical of the 510(k) process. ION called on FDA to set new guidelines for Class I and II approval. Medical device manufacturers have (of course) lashed back at the call for decent regulation. Mesh makers and other device makers have warned that any changes to the 510(k) process will threaten the device market and slow their steady stream of medical device miracles.
A Congressional bill introduced in 2012 to slow the 510(k) clearance process stalled. FDA announced in 2013 that it would make changes to the way some devices were approved, including the much troubled metal-on metal artificial hip implants.
Predicate Mesh Adulterated, Mis-branded
Because every transvaginal mesh device on the market today can trace its roots back to Boston Scientific’s ProteGen sling, we have a perfect example of how women’s pelvic mesh “innovation” was fraught with peril from the start. When Boston Scientific recalled the ProteGen after only three years, the company admitted: “[I]t did not appear to function as intended.” BSC said ProteGen had a high rate of erosion. The FDA, in addition, called the ProteGen “adulterated” and “mis-branded.” Nonetheless, because the device was withdrawn “voluntarily,” it has continued to be used as a predicate device for all subsequent transvaginal mesh devices.
Mesh Lawyers argue Pelvic Mesh not approved
It seems the height of absurdity that the predicate device for a 510(k) “approved” product was withdrawn, and yet all the subsequent devices are still allowed to lean on that predicate; but that is only part of the absurd legal tangle that exists. Plaintiff’s lawyers from Matthews & Associates and other firms have repeatedly pointed out in court trials that the makers of pelvic mesh are leaning on a predicate that was not legitimate, was “adulterated” and “misbranded.” More often than not, juries have agreed.
Free Legal Consultation
Matthews & Associates continues to successfully pursue transvaginal mesh lawsuits across the country. If you or someone you love was injured by pelvic mesh, contact an experienced transvaginal mesh lawyer today for a free legal consultation. Please see our testimonials for evidence in how we have helped others.
Related
- Obesity Balloon Lawsuit
- Transvaginal Mesh Lawsuit
- $73 Million Verdict in Pelvic Mesh Case
- Pelvic Mesh Verdicts mount against Johnson & Johnson
- Pelvic Mesh Trial set for Dallas Sept. 2015
- Consumer Reports: Faulty Medical Device Approval Process
by Matthews & Associates
