House Democrats called for congressional hearings on a gastric band made by Allergan Inc. (AGN) and transvaginal meshes of the kind made by Johnson & Johnson, saying the devices are hazardous to patients.
U.S. Representative Henry Waxman, a California Democrat, and three colleagues urged Republicans who control the House Energy and Commerce Committee to hold the hearing and demand documents from manufacturers. The inquiry is critical as Congress considers an overhaul of Food and Drug Administration rules for medical devices, the Democratic lawmakers said today in a statement.
The FDA ordered New Brunswick, New Jersey-based J&J and 32 fellow manufacturers to conduct safety studies of the vaginal implants earlier this month, citing reports of internal injuries. The Democrats said studies also showed high rates of complications with the Lap-Band made by Allergan.
“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,” Democrats said in a letter to the Republicans today. “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.”
The Democrats cited a study, published this week in the medical journal Archives of Surgery, that found almost half of patients with a gastric band had no weight loss or needed the device removed after six years. More than 40 percent had long- term complications, the letter said.
Older Product
The study used an older band and an older surgical technique, said Naziah Lasi-Tejani, a spokeswoman for Irvine, California-based Allergan, in a telephone interview. Using a newer version and updated techniques, the rate of patients needing a follow-up operation is three times lower, she said.
Complication rates in the study were also “significantly higher” than what Allergan (AGN) has seen in clinical practice, suggesting doctor training is key, Lasi-Tejani said.
Matthew Johnson, a J&J spokesman, didn’t return a message seeking comment.
Congress has until October to reauthorize a law that funds the FDA’s review of new products. House Republicans’ hearings so far threaten to give a “skewed” portrait of the situation, the Democrats said in today’s letter. They said Republicans still haven’t responded to an October request to hold a hearing on artificial hips and implanted brain stents that have also raised safety concerns.
Thorough Review
The Energy and Commerce Committee is “thoroughly examining” device rules and plans another hearing on Feb. 15, said Debbee Keller, a spokeswoman for the committee’s Republican majority. She didn’t give specifics on the hearing’s agenda.
“Both the majority and minority have selected witnesses to testify, bringing patients, innovators, investors, job creators, and administration officials before the committee in the last several months,” Keller said in an e-mail. “Members on both sides of the aisle agree the status quo is unacceptable.” (…read more)
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Evolving TAVR Market, Edwards Lifesciences EW, medical devices companies, widespread economic uncertainty, reimbursement pressure, declining procedure volume, forced to look for other solutions, restructuring initiatives, focus on emerging markets, nascent technologies, innovation and state-of-the-art medical technology, transcatheter aortic valve replacement TAVR, players adopting the acquisition route, Dr Alain Cribier, alternative option for treating patients with aortic stenosis, FDA has hitherto approved TAVR only for senile aortic stenosis, Senile aortic valve stenosis, progressive, age-related disease, calcium deposits on the aortic valve, cause the valve to narrow, heart works harder to pump enough blood through the smaller valve opening, weakens, problems such as fainting, chest pain, heart failure, irregular heart rhythms, arrhythmias, cardiac arrest, half of the patients succumb within a couple of years, Open heart surgery, the standard of care, restore the normal blood flow, replacing the diseased valve, many patients with age working against them, myriad of complications, unsuitable for this open surgery, approximately 300000 people worldwide, diagnosed with severe aortic stenosis, one-third are considered ineligible for open heart surgery, meet the urgent need of patients unfit for open heart surgery, Edwards Lifesciences EW, Sapien transcatheter heart valve THV in the US November 2011, originally developed to be delivered through two approaches, transfemoral via the patient’s femoral artery, transapical via a small incision between the ribs, FDA approval for transfemoral, first mover advantage in the US market, Medtronic MDT, CoreValve, enrollment in the US pivotal study of CoreValve, scheduled for completion in mid 2012, European market, cut throat competition, both Medtronic and Edwards in the fray since 2007, stalemate in Europe, Medtronic’s CoreValve portfolio in Europe includes 26mm, 29mm and 31mm valves, via three access routes, transfemoral, subclavian through the subclavian artery located beneath the collar bone, direct aortic access, self-expanding platform, Approval for the 23mm valve is expected in the second half of fiscal 2012, targeting the TAVR market in Europe, competitive landscape is likely to change, recent launches of two TAVR systems, JenaValve from Germany based JenaValve Technology, Acurate TA by Switzerland based Symetis, devices approved for transapical procedures, Candidates in queue include Engager from Medtronic, acquisition of Ventor Technologies in 2009, Boston Scientific Corporation’s BSX Lotus valve, acquisition of Sadra Medical in January 2011, St Jude Medical’s STJ Portico valve, valve from Direct Flow Medical, Medtronic began a pivotal trial for the Engager system, to be delivered through transapical approaches, Boston Scientific plans to launch Lotus in EMEA in the second half of 2013, St Jude Medical is targeting a limited launch of the Portico valve in Europe before the end of 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before they attain the desired level of proficiency, proper selection of patients, economic potential of this specialized, state-of-the-art procedure, devices are priced at a hefty premium to conventional surgical valves, Sapien has a price tag of $30000, prevailing economic uncertainty, adoption of austerity measures, force the players to increasingly compete on price, Edwards is in an advantageous position on the transapical side, JenaValve and Acurate TA, on the transfemoral side Medtronic’s CoreValve had a larger share before the introduction of Edwards’ Sapien XT, shortcomings of TAVR, Aortic stenosis is an insidious disease, Surgical replacement of the aortic valve, reduces symptoms and improves survival, absence of serious coexisting conditions, severe symptomatic aortic stenosis, surgery for replacement of the aortic valve, left ventricular dysfunction, presence of multiple coexisting conditions, high surgical risk, less invasive treatment, Transcatheter aortic-valve 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