Furthermore, a Government Accountability Office report found that once recalled, many of the highest-risk devices are not corrected or removed from the market.

Surgical Mesh

Implantable surgical mesh acts a reinforcement structure for internal organs, and is often used to treat pelvic organ prolapse or stress urinary incontinence in women.

The FDA first cleared vaginal mesh in the late 1990's based on its similarity to earlier products used to fix internal hernias. Despite using a different method of implantation (inserted through the vaginal wall, rather than with abdominal surgery) and for an entirely different part of the body, surgical mesh "kits" were advertised as a new and improved method to treat urinary incontinence.

In 1999, Boston Scientific voluntarily recalled its surgical mesh product called the ProteGen Sling, after numerous complaints of pain, infections, and injuries. Over a decade later, Johnson & Johnson faced hundreds of lawsuits over a surgical mesh device that was substantially similar (in fact had been cleared based on its similarity) to the ProteGen Sling.

In 2008 the FDA said that surgical mesh complications were serious, but rare. Over the next two years, complaints grew to the thousands, and doctors and patients reported five times as many mesh complications as previous years. According to a 2011 FDA report, total "adverse event" reports for all medical devices – not just mesh – have risen an average of 15 percent a year for the past decade.

2011 FDA Report on Understanding Barriers to Medical Device Quality

In the case of vaginal mesh, the most common problem was mesh eroding and sticking through the walls of the bladder or vagina, causing burning and pain. A study in the journal Obstetrics and Gynecology found that 15 percent of the women treated with vaginal mesh had complications, and that the mesh was no more helpful than other repair treatments. Boston Scientific has repeatedly stated that mesh is a safe and effective treatment option.

In July 2011, the FDA said that serious complications with mesh are "not rare" and may expose patients to more risk. In January of this year, the FDA finally ordered manufacturers to conduct studies of surgical mesh.

2011 FDA Update on the Safety of Surgical Mesh for Pelvic Organ Prolapse

Heart Valve Rings

An annuloplasty ring is a circular device used to repair faulty heart valves, by pinching together two flaps that normally prevent blood from leaking back into the lungs or another heart chamber. Given their critical role in sustaining life, the rings were originally classified in the highest risk class. For these very high-risk devices, manufactures often go through a premarket approval (PMA) process, which requires clinical data that a device is safe. But the FDA also clears dozens of high-risk medical devices each year through the less stringent 510(k) process – and over the past decade, that number has increased dramatically.

4 Comments

1. 1. czlc89 09:18 AM 5/1/12

   The 510(k) was originally meant for low risk devices. Now manufacturers are exploiting this loophole in order to dodge proper safety practices at the cost of consumer safety:
   http://www.newsinferno.com/defective-medical-devices/metal-on-metal-hip-implants-endangering-thousands-thanks-to-lax-regulation-in-u-s-and-abroad/35936
   

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2. 2. czlc89 09:20 AM 5/1/12

   The 510(k) was originally meant for low risk devices. Now manufacturers are exploiting this loophole in order to dodge proper safety practices at the cost of consumer safety:
   <a href="http://www.newsinferno.com/defective-medical-devices/metal-on-metal-hip-implants-endangering-thousands-thanks-to-lax-regulation-in-u-s-and-abroad/35936">Metal-on-Metal Hip Implants Endangering Thousands, Thanks to Lax Regulation in U.S. and Abroad </a>
   

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3. 3. KattM 10:18 AM 5/1/12

   Is this a case of FDA bad practices or simply having to be more "efficient" because there isn't the funding or manpower to conduct the longer, more thorough review processes?

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4. 4. rahnrm 02:28 PM 5/1/12

   Only four - are you kidding, where have you been hiding?
   According to an article entitled; Medical device recalls and the FDA approval process by Diana M. Zuckerman et.al, and published in Arch Intern Med.2011Jun13;17(11):1006-11
   
   There were 113 recalls from 2005 through 2009 that the FDA determined could cause serious health problems or death.
   
   Only 21 of the 113 devices had been approved through the PMA process (19%).
   Eighty were cleared through the 510(k) process (71%),
   and an additional 8 were exempt from any FDA regulation (7%).
   
   Cardiovascular devices comprised the largest recall category, with 35 of the high-risk recalls (31%); two-thirds were cleared by the 510(k) process (66%; n=23).
   Fifty one percent of the high-risk recalls were in 5 other device categories: general hospital,anesthesiology, clinical chemistry, neurology, or ophthalmology.
   
   In addition to the 113 recalls – you may remember even older recalls:
   
   Dalkon Shield IUD made by A.H. Robins
   Proplat-Teflon Jaw Implant by Vitek, Inc. for (TMJ)
   Ivalon (polyvinyl) sponge breast implants
   Polyurethane coated breast implants
   Trilucent (soya bean oil) breast implants

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