Mesh Medical Device Newsdesk » premarket review

FDA: Stress Urinary Incontinence (SUI) Surgical Mesh Reports up 36 Percent

Jane Akre — Fri, 29 Mar 2013 05:17:24 +0000

March 29, 2013 ~ In September 2011, the U.S. Food and Drug Administration convened a panel of experts to try and get a handle on the concerning number of complications the agency was receiving about surgical mesh used to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI).

The experts suggested that because of the number of POP complications at the time (1,503), that mesh for POP be reclassified from Class II to a Class III or high-risk device. That would require a rigorous premarket review process before mesh manufacturers could sell their product, unlike the pre-market notification that is required now. Many critics suspect POP surgical mesh would never be approved for safety and efficacy if that happened.

But no changes were made and at this time surgical mesh for POP and SUI remains Class II or a low-to-moderate-risk medical device.

The expert panel said it would further consider reclassifying SUI surgical mesh and the FDA promised an update at a later time.

With no notification, the FDA on Wednesday, March 27, updated its information on SUI mesh.

What Is New? SUI Adverse Events Increasing

The agency says it has analyzed adverse event reports, conducted epidemiological research on the safety and effectiveness of surgical mesh for POP and SUI and collaborated with professional societies to understand postmarket performance.

The timing is interesting on the latter point. It should be noted that the FDA update comes one day after the American Urogynecologic Society (AUGS) issued a new policy statement that resists any suggestion mesh use be banned or severely restricted. See it here.

What’s new is the FDA has continued to monitor SUI mesh injuries.

Back in July 2011 (here) when the second Safety Communication was issued by the FDA saying mesh complications were “not rare,” it released the number of adverse events that had come into the FDA at that time.

“From Jan. 01, 2008 through Dec. 31, 2010, the FDA received 2,874 additional reports of complications associated with surgical mesh devices used to repair POP and SUI, with 1,503 reports associated with POP repairs and 1,371 associated with SUI repairs. Although it is common for adverse event reporting to increase following an FDA safety communication, we are concerned that the number of adverse event reports remains high.”

The agency continued its review of SUI complications and now reports from January 1, 2008 through September 30, 2011, the FDA received “1,876 reports of complications associated with surgical mesh devices used to repair SUI.”

That represents more than a 36% increase in adverse event reports to the FDA in nine months.

Advocating SUI Mesh

While advising not every woman experiencing SUI will need surgery the FDA appears to endorse sling surgery over non-mesh repairs on the What is Stress Urinary Incontinence? page (here) by saying:

“The use of surgical mesh slings to treat SUI provides a less invasive approach than non-mesh repairs, which require a larger incision in the abdominal wall. The multi-incision sling procedure can be performed using three incisions, in two ways: with one vaginal incision and two lower abdominal incisions, called retropubic; or with one vaginal incision and two groin/thigh incisions, called transobturator. There is also a “mini-sling” procedure that utilizes a shorter piece of surgical mesh, which may be done with only one incision.”

Recommendations for Health Care Providers

What’s new may be an additional recommendation to health care providers that encourages the surgeon receive specialized training for each SUI mesh placement technique. The American Urogynecologic Society (AUGS) in its policy statement just released also recommends more specific training for doctors.

The FDA also encourages doctors to be fully informed about:

The likely success of transvaginal SUI surgery compared to a non mesh surgery
The potential postoperative complications and its effect on the quality of lift
That there is limited information about outcomes after one year
The specific product to be used
That a mesh sling is a permanent implant
That SUI surgery using mesh can make any future surgeries more challenging and can “put the patient at risk for additional complications and surgeries.”
Ensure the patient understands the post-operative risks and potential complications
Provide the patient with the labeling or brochure

You’ll recall that during the Linda Gross v. Ethicon case, it became clear that there was a “failure to provide adequate warning” to her implant surgeon Dr. Benson by a jury vote of 7-yes and 2-no. That means the surgeon also may not have enough information to provide an adequate “informed consent.”

*Editors Note* Without being able to compare the original FDA pages to this newly updated information it is difficult to determine which represents a departure for the FDA in terms of SUI mesh. MDND requested a comparison to answer that question on Thursday. We’ll update you when that is forthcoming. #

ProPublia: Four Medical Devices that Bypassed FDA Scrutiny

Jane Akre — Thu, 10 May 2012 20:05:00 +0000

Mesh after removal

May 10, 2012 ~ ProPublica, an independent journalism organization, reports on four medical devices that are among the thousands pushed into the marketplace every year that do not undergo Food and Drug Administration (FDA) scrutiny.

The bottom line – medical devices are big business bringing over $100 billion-a-year to the industry, giving industry the muscle to get what it wants – products to market quickly and with the least cost.

Unlike the scrutiny drugs must undergo, when a medical device is fast-tracked onto the market without premarket review for safety, the public becomes the real-world clinical trial and we see the complications.

The fast-track process is called 510(k) and after a fee and an exchange of paperwork, the manufacturer must name a ‘predicate’ or a device already on the market that their new device resembles. The new device is okayed for marketing by the FDA. The Institute of Medicine last spring called the 510(k) process “fatally flawed” and recommended it be abolished, but the FDA did not adopt the recommendation of the IOM.

Most low, medium and some high-risk permanently implanted medical devices are put on the market through the 510(k) process.

In January, 31 mesh manufacturers received letters from the FDA requiring three years of post-implant surveillance to monitor the complication rate. This is after the device is already implanted in women. Background story is here.

It should come as no surprise then that transvaginal mesh, used in women, makes the Big Four.

Prolene mesh

Surgical Mesh

ProPublica reports implantable surgical mesh is a reinforcement structure used to shore up organs that have prolapse through the vagina or to treat stress urinary incontinence.

Problems: First used in the 1990s to fix internal hernias, the invention of surgical mesh “kits” appear to have accelerated the rate of complications with the FDA noting in 2011 that the thousands of complications reported to the agency represented a five-fold increase in recent years and an average of 15 percent a year over the past decade. When the FDA reported that complications are not rare and that the benefits of using polypropylene mesh may not be worth the risks, lawsuits were filed by the hundreds against the four main manufacturers, Boston Scientific, Ethicon, C.R Bard and American Medical Systems.

The industry continues to report that mesh is safe and any problems are due to the training of implant surgeons.

Hip Implants

As the Baby Boomer population ages, thousand of Americans are affected by advanced arthritis and broken hips and get a total hip replacement. Traditionally the implants contain a metal head that fits into a plastic cup. In 2005, Johnson & Johnson’s DePuy Orthopaedics introduced a metal-on-metal (MOM) hip claiming it was “substantially equivalent” to other artificial hips already being marketed. With the exception of the MOM hips that used a novel approach called “resurfacing,” metal hips went on the market after passing 510(k) scrutiny for substantial equivalence.

DePuy metal hip

Problems: According to the British Hip Society, the DePuy had a failure rate of almost half of the patients who received implants within six years. Hips are designed to last about 15 before they need to be replaced but patients had metallic particles in the blood and surrounding tissue. Joint pain from metal caused thousands of complaints and lawsuits. The DePuy was recalled in 2010 based on new information the company said it received, but not before almost 100,000 patients had the DePuy hip implanted.

Heart valves, from ProPublica

Heart Valve Rings

Heart valves or annuloplasty rings are a circular device that pinch together flaps of the heart valve to prevent blood from flowing back into the lungs or heart. Originally classified as high risk or Class III, they were supposed to go through premarket approval (PMA), a process that requires clinical studies to prove a device is safe before it makes it to the market. That all changed in 1997. After petition the government, the FDA agreed to lower the class risk to Class II or moderate-risk even though the rings were implanted putting it in a class with sutures and hearing aids.

That means if you seek a replacement heart valve, you can be sure the medical device has gone through rigorous FDA examination, not so for the rings which undergo 510(k) approval for sale. Advanced Medical Technology Association, AdvaMed, the aggressive industry trade group was behind the reclassification, reports a Chicago Tribune investigation.

Problem: Annuloplasty rings top Class II in the number of deaths. ProPublica reports manufacturer, Edwards Lifescience, didn’t even bother to go through the fast-track 510(k) clearance process, instead marketing the Myxo ring which was implanted in more than 100 people without any FDA clearance. The FDA let the company off the hook saying it made an “honest attempt” to interpret the regulations.

Defibrillator lead, ProPublica

Defibrillator Leads

A defibrillator can be implanted in the chest of a cardiac patient to deliver life-sustaining shocks when it suspects heart failure. Leads connect the defibrillator to the heart and they are supposed to deliver the shock when needed, then shut off. However problems arose when faulty defibrillator leads fired unexpectedly or failed to fire when needed. The industry is a $10 billion dollar one that has had more than its share of failures and lawsuits.

Problems: The St. Jude’s Riata lead was recalled last year because of a potential to short circuit in the body or deliver a high voltage, but not before about 79,999 patients received the medical device. The group reports the maker knew about the problems for a full year before the recall. That led to an additional 20 deaths. The company says the device went in for a redesign and is conducting a study of the Riata lead.

Knowing there is a problem with medical devices and the people they harm, the FDA is considering an enhances premarket, postmarket and compliance plan, but that takes additional funding, a portion of which comes from the very medical device industries the FDA monitors.