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.”
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.
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.
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:
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. #