Showdown in House Hearings Over Mesh, Medical Devices

Jan 24th, 2012 | By | Category: Media Reports

Allergan Lap-Band video

January 23, 2012 ~ House Democrats are asking Republicans for a hearing on Johnson & Johnson synthetic surgical transvaginal mesh used to treat pelvic organ prolapse, and the Allergan Lap-Band for weight reduction because of a growing number of patient injuries and a fear that device makers and the U. S. Food and Drug Administration (FDA) may not be protecting patients.  

Here is the January 20 letter.

Today Rep. Henry Waxman (D-CA) issued a statement reported by Bloomberg.

“The committee should hold hearings to examine whether FDA device regulation has been ineffective in protecting the public from dangerous medical devices like the Lap-Band and intravaginal mesh…“We need to understand the safety of devices on the market, the tactics device manufacturers and others use to market these devices, and the extent to which these tactics may increase risks.”

Rep. Henry Waxman, D-CA

Democrats Waxman, Reps. John Dingell (D-Michigan) and Diana DeGette (D-CO) want the Republicans on the House Energy and Commerce Committee to revisit a similar request letter last October that asks for hearings on two other controversial medical devices, brain stents and metal-on-metal hip implants. That request was never honored.

Here is the October letter.

What’s the Problem?

Rep. Waxman says it’s clear devices are on the market that pose dangerous risks such as Urogynecologic Surgical Mesh.

The FDA did not require any clinical data before clearing mesh for female procedures to be marketed under the 510(k) process as it was “substantially equivalent” to one or more devices already being sold.

The Democratic lawmakers reminded Committee members that there have been two FDA warnings about surgical mesh. First in October 2008, (here) the FDA noted an increased number of complications associated with transvaginal surgical mesh and a Public Health Notification called it “an area of continuing concern.”

By July 2011, (here) there were more than 2,800 incidents of complications associated with synthetic mesh. Despite that, the products remain on the market.

In 2010, an estimated 300,000 women were implanted with synthetic vaginal mesh.

Lawmakers want manufacturers to bring documentation that shows when they first learned of safety risks associated with surgical mesh and what they did to minimize risks to patients.

Last week the FDA ordered Johnson & Johnson and 32 other manufactures of synthetic surgical mesh for pelvic organ prolapse and incontinence to begin a three-year followup of patients implanted with the controversial medical device. Background story here. The agency also said it was considering reclassifying transvaginal mesh (implanted through the vagina) as a Class III or the highest risk medical device.

Allergan Lap-Band from website

Lap-Band Medical Device

The lawmakers want Republican members to investigate the ads for weight-loss. 1-800-GET-THIN promotes the Lap-Band surgery in which doctors implant a ring around the stomach to give the patient a feeling of fullness. and they ask for congressional hearings to examine the 1-800 Get-Thin campaign and whether the maker, Allergan is improperly promoting a potentially dangerous surgery, according to a story in the Los Angeles Times (here).

In December, the FDA sent out warning letters to Allergan, maker of the Lap-Band. See FDA notice.

Allergan added a disclosure that death can occur from lap-band surgery in its product insert (here).

The Los Angeles Times reports that 5 Southern Californians have died from the procedure since 2009. A study in the journal Archives of Surgery finds half of gastric band patients had no weight loss or had to have the medical device removed after six years.  And more than 40 percent of patients had long-term complications, according to the Democrats’ letter.

Meanwhile Allergan is seeking FDA approval to expand the market for this medical device to include children and young adults, according to an article in the Los Angeles Times in June. (here)

Lawmakers are afraid that aggressive marketing including roadside billboards and magazine inserts that minimize the potential consequences may cause young people to overlook the health concerns for an easy avenue to weight loss.

Debbee Keller, a spokesperson for the committees Republican majority tells Bloomberg Businessweek that the committee is “thoroughly examining” medical device regulations and will hold a hearing February 15. 

Opposition to Tough Regulation

However the Committee has not yet scheduled the request issued last October for hearings on metal-on-metal hip implants and brain stents, other medical devices with known complication rates.  Just to make a point of where it stands, last September House Republicans on the committee hosted a first-of-its kind Jobs and Innovation Forum focusing on medical devices and how the FDA review process hurts Americans by not making innovative devices more readily available  and forces jobs overseas where these devices are approved.

See the video here:

Rep. Cliff Stearns ( R-FL)

The Chairman of the House Energy and Commerce Committee’s Subcommittee on Oversight and Investigations, Rep. Cliff Stearns (R-FL) is on record as saying “The medical device industry has brought hundreds of thousands of high-paying jobs to our country and life-saving, life-improving devices to our nation’s patients in a safe and efficient manner.

He blames regulatory inconsistency and inefficiency at the FDA to cause the medical device industry to move offshore (here).

At a hearing last July, Rep. Stearns again echoed industry concerns about job creation and the least burdensome tools for regulatory ends. (audio is poor). And he brought forward patients who testified that FDA regulations had denied them much-needed medical care.

Timing is Everything

By October 2012, Congress must reauthorize funding for the FDA that will allow the agency to continue its review of new medical devices so the timing of these requests is crucial. Lawmakers need to understand whether aggressive marketing is putting hazardous devices for sale with little regard to the public. #


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4 Comments to “Showdown in House Hearings Over Mesh, Medical Devices”

  1. Amy G says:

    Wow approving a permanently implanted device after a 90 day study in rats isn’t fast enough?

  2. Darliene Howell says:

    I have written my Representative asking for them to support Rep. Waxman. Here are some of the facts on lap-banding, which is supposed to be the least invasive form of WLS.

    • Finland no longer allows gastric banding surgery after studies concluded that as many as 40% of people had to have follow-up operations to treat complications.
    • A study published this year in Archives of Surgery reported that “because nearly 1 out of 3 patients experienced band erosion, and nearly 50% of the patients required removal of their bands (contributing to a re-operation rate of 60%), [banding] appears to result in relatively poor long-term outcomes.”
    • A Dutch research study of 201 patients who had the procedure between 1995 -2003 concluded that adjustable gastric banding not only results in modest weight loss, but the benefit of the procedure deteriorates over time.
    • Eating Disorders Review highlights that 80% of adjustable gastric banding patients retained weight loss during the first three years then decreased to 64% at five years and just 20% at ten years following surgery. In addition, significant deterioration of diabetes control and hypertension became evident over time.

    Advertisers prey on people’s insecurities and desires to “fit in” in order to sell a product. They try to sell you the “quick fix” for whatever type of imperfection you feel you have. Children are even more susceptible to advertising due to undeveloped critical thinking skills.

    There is an evidence-based compassionate alternative to bariatric surgery: Health At Every Size®. For more information on Health At Every Size®, you can find in-depth research-based information in the book Health At Every Size – The Surprising Truth About Your Weight by Dr. Linda Bacon (http://www.lindabacon.org/HAESbook/).

    • Jane Akre says:

      Darliene- Thanks so much for the interesting information! Really appreciated. And thank you for contacting Rep. Waxman. Right now is really the time to let our lawmakers know how you feel. There are contact numbers for Reps. Pitts and Stearns who appear to be emphasizing the medical device manufacturers and spending less time on patient safety. Thank you!!!

  3. DJ says:

    You are doing a great job, Jane, keeping us informed on all the current events , and I just want to say that I really appreciate it. Thank you.
    Thank you, Darlene, for the important information on lap bands, a highly marketed surgery, with minimal talk about the many times ineffectiveness of it or the serious complications one can endure from it.

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