Website: Truth in Medicine USA
www.truthinmedicine.us.com/home.html

UPDATED 19th February 2012

19th February 2012
Truth in Medicine V.P. James P. Shull to testify at Congressional Hearing Today February 15, 2012
Jim Shull and Lana Keeton were in Washington last week talking to Senators and Congressmen/women along with Consumers Union asking to improve medical device safety. We got great results! Jim is testifying before the House Energy and Commerce Committee this morning. Our goal this year is to get the same warning issued for hernia repair mesh as was issued for transvaginal mesh. This is a huge step forward!

It is important to listen to all the video as below. It's a lengthy video but you can pause and go back to it later or make a note of the timeline you stopped at and return back to listen.

To hear from Ms Swirsky from Consumers Union talk on behalf of Lana Keeton founder of Truth in Medicine please go to timeline 3.00.48

To hear from Jim Shull Hernia mesh sufferer please go to timeline 3.06.16

Reauthorization of MDUFA: What It Means for Jobs, Innovation and Patients

Direct Link to view on YouTube:
www.youtube.com/watch?feature=player_embedded&v=VzthmRvtcNo >>>
Direct Link to website:
energycommerce.house.gov/hearings/hearingdetail.aspx?NewsID=9196 >>>

4th February 2012
Truth in Medicine
Doctor Disconnect:
Synthetic Surgical Mesh Myths and Lies
By Lana C. Keeton
If you went to your barber for a haircut and he cut out a chunk of your scalp, along with your hair, you would find another barber. Yet it is accepted practice, and even recommended by prominent surgeons…and paid for by insurance companies…to remove “chunks” of a woman’s vagina or bladder, or other tissue or organ, to remove pieces of “eroding” surgical mesh. Without anesthesia, I might add. This is a barbaric practice.. To read more please click on the link below:-
www.tvt-messed-up-mesh.org.uk/truth-in-medicine-doctor-disconnect.html >>>

12th January 2012
FDA Orders Safety Studies for Vaginal Implants Made By J&J and C.R. Bard
Johnson & Johnson (JNJ) and C.R. Bard Inc. (BCR) must study rates of organ damage and complications linked to vaginal mesh implants, U.S. regulators said, responding to patient advocates who say the devices have harmed women.

The Food and Drug Administration wrote J&J, C.R. Bard and 31 other manufacturers, telling them to conduct three years of trials on safety and effectiveness, the agency’s William Maisel said yesterday in a telephone interview. An FDA report in July found a fivefold jump in deaths, injuries or malfunctions tied to the products.

Almost 300,000 synthetic meshes were implanted in U.S. women in 2010 to treat incontinence or shore up pelvic muscles, the agency estimates. The devices’ alleged failures have spurred more than 650 lawsuits against manufacturers and heightened scrutiny of the FDA program that cleared the products for sale without human testing.

“Now these companies are going to have to tell the truth,” said Lana Keeton, a mesh recipient and patient advocate from Austin, Texas. While companies say implants are safe, “up until now, there’s been no data,” she said. “It’s all been marketing.”

J&J, the biggest maker of vaginal mesh, fell (JNJ) less than 1 percent to $65.40 at the close in New York. C.R. Bard also declined (BCR) less than 1 percent to $85.94. J&J is based in New Brunswick, New Jersey, and C.R. Bard in Murray Hill, New Jersey.

The letters ask each manufacturer to collect data on the results and potential complications of transvaginal procedures, in which the hammock-like meshes are threaded in place through an incision in the vagina. The FDA said in July that it wasn’t clear from available studies whether the devices provided a benefit over older methods in certain cases.

Guiding Doctors
“We believe there are certain uses of mesh where we need additional data to help guide the clinical community,” said Maisel, deputy director of science for the agency’s device- approval center. “Our goal is to make sure the right women use it at the right time.”

The meshes were approved through the FDA’s 510(k) system, which allows products to reach the market without human testing if the agency decides they’re similar to devices already for sale. In October, Bloomberg News reported many implants can trace their approvals back to a Boston Scientific (BSX) Corp. mesh recalled for safety concerns in 1999.

Yesterday’s letters covered only devices already on the market. Consumer groups say they want the action to be just a first step toward requiring studies before the products can reach the market, said Amy Allina, a policy director at the National Women’s Health Network in Washington.

‘The Right Thing’
“It would have been better if the products that had hurt women had never gone out in the first place,” she said in a telephone interview. “But now that they’re out there, we’re encouraged to see the FDA doing the right thing and requiring the companies to provide more information.”

Even before the studies are done, they will serve to warn off patients, said Keeton, the Texas woman and founder of the group Truth in Medicine.

“What woman’s going to sign up for a study when they know” the potential complications, she said by telephone.

Keeton sued J&J over injuries she blamed on a 2001 implant. The case was dismissed by a federal judge in 2007. She has also worked as a paid consultant to lawyers suing mesh makers.

Matthew Johnson, a spokesman for J&J’s Ethicon unit that makes the devices, said the company was reviewing the correspondence from the FDA.

‘Most Studied’ “Ethicon’s transvaginal mesh devices are already among the most studied devices on the market, and we will continue to support their use in surgical repair with clinical evidence, through investigator-initiated and company-sponsored trials,” he said in an e-mail.

The FDA letters also went to companies including Endo Pharmaceuticals Holding Inc. (ENDP) of Chadds Ford, Pennsylvania, and Boston Scientific, based in Natick, Massachusetts. The companies have 30 days to respond.

Kevin Wiggins from Endo Pharmaceuticals and Eric Olson from Boston Scientific didn’t return phone calls seeking comment. Scott Lowry, a C.R. Bard spokesman, also didn’t return a message.

The edges of mesh fibers can constrict or cut into internal organs after they’ve been implanted, studies have found. The procedure is also prone to infection because the vagina through which the devices are inserted isn’t a sterile environment, said Clifford Wheeless, an emeritus associate gynecology professor at Johns Hopkins University (43935MF) School of Medicine, in a telephone interview last year.

High-Risk
In September, an advisory panel recommended the FDA reclassify mesh used for pelvic organ prolapse, a condition in which weakened muscles fail to support internal organs, as “high-risk” devices that require human testing. The FDA hasn’t made a decision yet, Maisel said. The agency isn’t likely to heed the call of some patient advocates for a complete recall, he said.

“There’s strong support in the clinical community that mesh serves a role for certain patients,” Maisel said. “Our goal is not to completely remove these products from the market.”

Manufacturers sell about $175 million worth of prolapse mesh worldwide and another $295 million for incontinence treatments, C.R. Bard executives estimated on a conference call in 2010. Even for the top sellers, the products make up only about 1 percent to 2 percent of sales, said Michael Matson, a Mizuho Securities USA analyst in New York.

“Patients are already well aware of these issues and the markets have been declining already,” he said.

To contact the reporter on this story: Alex Nussbaum in New York at anussbaum1@bloomberg.net; David Voreacos in Newark, New Jersey at dvoreacos@bloomberg.net;

To contact the editor responsible for this story: Reg Gale at rgale5@bloomberg.net; Michael Hytha at mhytha@bloomberg.net

To read more showing Bloomberg website please click on this link:- www.bloomberg.com/news/2012-01-05/fda-orders-safety-studies-for-vaginal-implants-made-by-j-j-and-c-r-bard.html >>>

Truth in Medicine applauds Senators Standing Up for Patients
21st December 2011
For Immediate Release
Dateline: Miami Beach, Florida
December 19, 2011

Congratulations to Senator Herbert Kohl, Senator Richard Blumenthal and Senator Chuck Grassley for their bi-partisan Medical Device Patient Safety Act. Truth in Medicine applauds and supports their actions and sees this as a spectacular win for patients. Bravo! To read more please click on this PDF www.tvt-messed-up-mesh.org.uk/Truth-in-Medicine-applauds-Senators-Standing-Up-for-Patients.pdf >>> or you can read the full text below:-

For Immediate Release
Dateline: Miami Beach, Florida
December 19, 2011

Truth in Medicine applauds Senators Standing Up for Patients

Congratulations to Senator Herbert Kohl, Senator Richard Blumenthal and Senator Chuck Grassley for their bi-partisan Medical Device Patient Safety Act. Truth in Medicine applauds and supports their actions and sees this as a spectacular win for patients. Bravo!

The 35 year old 510(k) Pre-market Notification (PMN) clearance process has been scrutinized by the Government Accounting Office (GAO), the Institute of Medicine (IOM) and the United States Food and Drug Administration (FDA) over the last 3 years, yet the FDA still operates under this antiquated law.

Written to give the FDA medical device regulation authority and, at the same time, eliminate unfair competition between devices already on the market and new devices entering the market after 1976, there is no requirement of safety or efficacy, only substantial equivalence. This concept has long since lost its validity. The distortion of the PMN process over the last 35 years rivals a good game of “gossip”. Many of today’s medical devices sold as “substantially equivalent” in no way resemble their predicate devices sold before 1976. The FDA’s 510(k) does not protect patients. The Medical Device Patient Safety Act is a huge step toward making serious changes to the 510 (k) necessary to protect patients.

Truth in Medicine has been sounding the alarm over the use, misuse and overuse of synthetic surgical mesh for hernia repair, bladder suspension and pelvic organ prolapse repair. Truth in Medicine and its members have been showing up and speaking out in Washington, D.C. and across the nation over the last five years. Testimony at the Institute of Medicine’s (IOM) 510 (k) workshops in March, June and July 2010, testimony at the FDA’s Center for Devices and Radiological Health (CDRH) Town Hall meetings March and May 2011, attendance at the Senate Special Committee on Aging Congressional Hearing April 2011 (and statements entered into the Congressional Record for the hearing), testimony at the FDA’s ObGyn Advisory Panel Meeting Sept 8-9, 2011 and testimony at the FDA/IOM meeting Sept 16, 2011 all highlighted the devastating complications of synthetic surgical mesh for hernia repair, bladder suspension and pelvic organ prolapse repair.

Truth in Medicine sponsored events also spotlighted the serious harm, and even deaths, from the implantation of surgical mesh. It sponsored two conferences, one in September 2009, “Surviving the Complications of Synthetic Surgical Mesh”in Ft Lauderdale, FL and one in October 2010 “Alternatives to Synthetics” in Washington, D.C., a “Mesh Out” Rally on the steps of the U.S. Capitol October 2010 and a Capitol Hill briefing in May 2011 “Baby Boomers and Medical Devices: a Dangerous Mix for Healthcare” with world renowned urologist and pelvic repair specialist, Dr. Shlomo Raz at UCLA in Los Angeles, California.

Direct input to the FDA/CDRH by Lana Keeton, President and Founder, James P. Shull, Vice-President, and Janet Holt, Director, Regulatory Affairs of Truth in Medicine, through conference calls and in person meetings were instrumental in getting the FDA to issue two Public Health Notifications (PHN - Oct 2008 & July 2011) warning of the serious complications of transvaginal placement of mesh. The FDA also issued cautions on the use of mesh for hernia repair and bladder suspension. Meetings with the FDA’s Surgical Mesh Investigative Team, including Dr. Jeffrey Shuren, Director of the CDRH, and other senior personnel in March, November 2010 and May, November 2011 show the FDA’s serious concern for the harm caused by mesh.

While Industry’s latest argument is, “it’s not the device, it’s the doctor”, Ms. Keeton illustrated the fallacy of this position to the FDA in her latest meeting with the FDA’s Surgical Mesh Investigative Team, November 17, 2011. Adverse Events on the MAUDE database do not include a patient’s operative report, patients are not independently examined and the FDA does not regulate doctors. So how does industry arrive at this position? The defect is in the device, not the doctor, if the average surgeon is unable to successfully implant synthetic mesh. It is a useability of the design defect, not doctor error.

Permanent disability should not be the outcome of a “minimally invasive outpatient procedure”. Truth in Medicine continues its’ fight to stop the carnage caused by defective, untested medical devices by its support of the passage of the Medical Device Patient Safety Act. Our team, our incredibly talented Board of Directors, makes all this possible. A special thanks to Lorraine Evans, Director/Liasion to the U.K. and Europe, Kelly Villoch, Creative Director and Barbara Buttrick Smith, Secretary, for their dedication and perseverance to educating and supporting mesh injured patients and to stopping others from being harmed.

As Ms. Keeton puts it, “We are not going away. We will keep showing up anytime, anyplace necessary to turn the tide against patient harm by bad medical devices, especially synthetic surgical mesh.”

Lana C. Keeton
Founder and President
Truth in Medicine Incorporated
1521 Alton Road, #198
Miami Beach, FL 33139
phone: 305-671-9332 ext #1
cell ph: 786-566-7780
e-mail: lanakeeton@truthinmedicine.us.com
website: www.truthinmedicine.us.com

kohl.senate.gov/newsroom/pressrelease.cfm?customel_dataPageID_1464=4864 >>>

For Immediate Release
(202) 224-5653
GRASSLEY, BLUMENTHAL AND KOHL SEEK TO IMPROVE MEDICAL DEVICE SAFETY
12/15/11

WASHINGTON –U.S. Senators Chuck Grassley (R-Iowa), Richard Blumenthal (D-Conn.) and Herb Kohl (D-Wis.) today introduced legislation to help protect patients from unsafe medical devices and improve the management of recalls.

The Medical Device Patient Safety Act would give the Food and Drug Administration (FDA) important tools to discover problems with faulty medical devices sooner and to better manage recalls when problems do occur, without slowing down the approval process for new devices. The bipartisan legislation would allow the FDA to require post-market clinical studies for medical devices that pose potential safety risks, if they were approved through the expedited 510(k) review process. The bill also would implement Government Accountability Office (GAO) recommendations for improving recalls and give the FDA new authority to require conditional clearance pending safety studies for devices reviewed under the fast-track, 510(k) approval process.

"This reform legislation should be part of the reauthorization of the medical device user fee law next year," Grassley said. "The reforms incorporate well-founded recommendations from the Government Accountability Office and reflect the value of having a robust post-market surveillance operation in the FDA. Important information can be learned about product safety after a device is on the market, and when there are problems, the sooner the response, the better."

"Unsafe medical devices pose severe dangers to patients and impede approval of new, safe devices – causing significant costs to our economy as well as health," said Blumenthal. "This bill will help protect people from dangerous unsafe medical devices by demanding more consumer safeguards, improving recall management, avoiding costly recalls, and preventing irreversible injury to patients. By removing unsafe devices from the market more quickly and efficiently, we're preserving a faster approval track for safe and effective products to reach patients."

"Faulty medical devices, especially those implanted in the body, can have disastrous health impacts on patients," Kohl said. "This legislation will help ensure that FDA can act quickly and decisively when there's a problem, and that the drive toward getting new technologies to market won't come at the risk of patient safety."

Grassley, Blumenthal and Kohl have also sent investigative letters to five companies that recalled faulty medical devices requesting detailed information about how the companies conduct post-market surveillance and how the companies manage recalls when a product is pulled from the market. Letters were sent to Johnson & Johnson, for its DePuy metal-on-metal hip implant, which was the subject of a worldwide recall and an April 13, 2011, hearing of the Senate Special Committee on Aging; Medtronic for its Infuse product; Boston Scientific for Guidant's defibrillators; CR Bard for vaginal and hernia mesh products; and, Zimmer Holdings for its knee replacements.

"As the Special Committee on Aging's recent oversight hearing detailed, effective post-marketing surveillance practices allow companies to recognize problems with medical devices in a timely fashion, preventing expensive recalls later, and can also save lives and prevent unnecessary suffering," the letters state.

Background on 501(k)
FDA can clear new medical devices through the 510(k) process, named after section 510(k) of the Food, Drug, and Cosmetic Act, if the product is found to be substantially equivalent to a product already on the market. A device is considered substantially equivalent if the company shows it is at least as safe and effective as the predicate device.

While the FDA can request clinical study data, the 510(k) process is still considered a "fast-track" approval compared to the more lengthy Premarket Approval, or PMA, process. The 510(k) clearance process is intended for moderate risk devices, while the PMA process is intended for high risk devices.

kohl.senate.gov/newsroom/pressrelease.cfm?customel_dataPageID_1464=4864 >>>

Be Sure to listen to the podcast stories from Lana Keeton and other fellow Mesh Sufferers at the Institute of Medicine. Please click on this link to view www.tvt-messed-up-mesh.org.uk/institute-of-medicine.html >>>

2 May 2011

HOT news from Truth in Medicine USA advisable to read please -
Invitation to attend and support a Capitol Hill Briefing
Tuesday, May 17, 2011
11:45 – 1:15 p.m.
www.truthinmedicine.us.com/capitolhillbriefing.html >>>

Truth in Medicine Incorporated is a patient advocacy organization which educates the public about the potential risks and complications from the implantation of synthetic surgical mesh into the human body. The organization also educates and supports patients who have already been harmed by surgical implantation of synthetic mesh.

You Tube Video from 2nd Annual Conference
Washington, D.C. October 2, 1010
Mesh Patient Attendees Speak Out on Complications of Mesh

Truth in Medicine: Synthetic Surgical Mesh not safe or effective!

22 September 2010
Article in the Readers Digest September 2010 edition please visit the following links for the full article in PDF format
Medical Devices That Can Kill >>>
Full article in the Readers Digest >>>

18 September 2010

Thousands Harmed by Big Pharma! Conference 1st and 2nd Oct 2010

18 September 2010

Rally at Washington DC - 1st October 2010

14th June 2010
Agenda: The Committee on the Public Health Effectiveness of the FDA 510(k) Clearance Process will hold a public workshop on June 14-15, 2010 in Washington, DC. The purpose of the workshop is for the committee to gather information related to the statement of task. YOU CAN HEAR STORIES FROM SUFFERERS AT TRUTH IN MEDICINE - USA Showing on our website. Institute of Medicine >>>

Truth in Medicine Incorporated is a patient advocacy organization which educates the public about the potential risks and complications from the implantation of synthetic surgical mesh into the human body. The organization also educates and supports patients who have already been harmed by surgical implantation of synthetic mesh. Please click to view >>> Truth In Medicine USA

For information on the Transvaginal Tension Free Tape (TVT), Tension Free Vaginal Tape Obturator (TVT-O) and Trans-Obturator Tape and (TOT) medical device please view here >>> Information on the Medical Devices showing on our website

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