Website: Truth in Medicine USA
Updated on 24 August 2018
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Date: 23 August 2018
By: Lana Keeton
Meeting with US Food and Drugs Administration (FDA) on Wednesday, September 5, 2018
Please donate at http://www.truthinmedicine.us.com/donatetoourcause.html or http://www.plaintiffpoweredlaw.com/
The presentation will include:
1. An extensive list of serious synthetic surgical mesh adverse events that have gone unreported to the FDA, over 87,000 of them.
2. The history of synthetic surgical mesh going back decades to its proliferation and why it is used unnecessarily today for hernia repair, bladder suspension and pelvic organ prolapse.
3. How lack of adequate controls in the manufacturing process cause inherent defects causing the massive number of adverse events.
4. Better quality Instructions for Use (IFU) on the recommended surgical procedure for implantation.
5. The Wound Healing Process as it relates to all medical devices and the immune system.
6. How the lack of control in the manufacturing process by surgical mesh manufacturers causes significant harm to patients, including autoimmune disease.
There are over 87,000 women who have had at least one surgical removal of transvaginal surgical mesh. In other words, over 87,000 adverse events.
Up classifying mesh to Class III in the U.S. did not stop the proliferation of its use. In fact, it institutionalized it. I would like to see it recalled from the market to no longer be placed in a woman’s reproductive system.
I have given extensive scientific evidence to many members of your senior staff for years now that should have removed synthetic surgical mesh from the market long ago. At my last meeting at the FDA on August 22, 2014, I left a thumb drive with 40 studies/articles related to the failure of synthetic surgical mesh. No one ever responded to the information.
I look forward to meeting with the FDA so it will take the actions that should have been taken 10 years ago.
Lana C. Keeton
Truth in Medicine Inc ~ Med Device Expert LLC
Patient Advocate . Legal Consultant . Medical Device Expert ~Email: LanaKeeton@truthinmedicine.us.com
You can view more on Lana Keeton and her work please click on the following links:
www.tvt-messed-up-mesh.org.uk/institute-of-medicine.html > > >
www.tvt-messed-up-mesh.org.uk/truth-in-medicine-doctor-disconnect.html > > >
www.tvt-messed-up-mesh.org.uk/truth-in-medicine-take-action-with-truth-in-medicine-and-consumers-union.html > > >
More news throughout the years as below.
Date: 28th November 2012
Breaking News…..Major Victory for Women! And for Women’s Health Care!
Truth in Medicine Incorporated Dateline: Miami, FL, USA November 28, 2012
By Lana C. Keeton (copyright protected)
The Center for Devices and Radiological Health (CDRH) will be up classifying all Synthetic Surgical Mesh for Pelvic Organ Prolapse repair from Class II to Class III within one year. Even better, in the very near future, all but one of the most popular prolapse kits, will no longer be sold.
Please read more on the Truth of Medicine website:
Date: 30th October 2012
Transvaginal Mesh “Flawed on Every Level”
Date: October 22, 2012, 10:30:00AM. By Jane Mundy
Fort Lauderdale, FL: Lana Keeton is not suffering in silence. She was implanted with transvaginal mesh in 2001, a procedure that went horribly wrong and almost killed her. Since that time, Lana has been a patient advocate and instrumental in getting the FDA warnings on synthetic surgical mesh issued in 2008 and 2011.
Lana has also appeared as a speaker on the Transvaginal Mesh Panel at Mass Torts Made Perfect (April 2012) in Las Vegas. And she has spent thousands of hours researching surgical mesh. “Despite extensive studies written by experts about the horrific complications of synthetic surgical meshes, transvaginal mesh is still being used,” says Lana. “Commercialization of surgical mesh by multi-billion dollar pharmaceutical giants—such as AMS and Johnson & Johnson-- has substituted “surgical mesh kits” for good surgical skills.”
To read the full article please click on the links below:
Direct link to article:www.lawyersandsettlements.com/articles/transvaginal-mesh-tvt-sling/interview-tvt-sling-transvaginal-mesh-11-18166.html >>>
PDF: Transvaginal-Mesh-Flawed-on-every-Level.pdf >>>
Date: 18th April 2012
Truth in Medicine - Advancing Patient Safety in the Nation's Capitol! - For Immediate Release!
Lana Keeton, President and Founder of Truth in Medicine, continues to advance the work of the patient advocacy group through her outreach efforts that are increasingly landing the group in the public’s eye. Through hard work and perseverance, Keeton has earned a seat at the table in key venues. Ms. Keeton will present at Mass Torts Made Perfect in Las Vegas, April 20, 2012, is an invited guest lecturer at the UT Quest program at the University of Texas at Austin next January and sat on the FDA's Patient Stakeholder Panel Wednesday, March 28th in Washington, D.C. at the MDUFA III public meeting in advance of re-authorization by Congress this fall. To read more please click on the PDF as below:
18th April 2012
Transcript for Public Workshop - Medical Device User Fee Program Public Meeting
Date: March 28, 2012
UNITED STATES OF AMERICA
DEPARTMENT OF HEALTH AND HUMAN SERVICES
FOOD AND DRUG ADMINISTRATION
Abstract: Speaker Lana Keeton from Truth in Medicine USA - When I was fighting for my life following emergency surgery to remove a flesh eating bacteria on Christmas morning 2001, I had no idea I had a piece of polypropylene implanted in me a few days before by my doctor, a piece of petroleum waste by product they won't put in a gas tank, an untested, unsafe medical device cleared by the FDA.
Not only does the medical device industry produce products internationally, it produces harm internationally. Lorraine Evans, who's the U.K. Director of Truth in Medicine and founder of TVT Mum charity in Bristol, United Kingdom, recently received a response from the Department of Health after raising concerns to David Cameron, Prime Minister of England, and Andrew Lansley, the Secretary of State for Health, of the severe ongoing harm from synthetic surgical mesh. To read more please click on the PDF link as below:
Transcript-for-Public-Workshop -Medical-Device-User-Fee-Program.pdf >>>
Date: 4th April 2012
TVT Mum was involved in the recent Public Workshop - Medical Device User Fee Program
MDUFA III PUBLIC MEETING . MARCH 28, 2012
DEPT HEALTH & HUMAN SERVICES . HUBERT HUMPHREY BUILDING
To read more please click on the links below:-
Public Workshop - Medical Device User Fee Program Public Meeting, March 28, 2012 The purpose of the meeting is to provide an opportunity for stakeholders to present their views on the draft recommendations for the reauthorization of the medical device user fee program. We welcome this opportunity to hear from stakeholders as we conclude negotiations for the next reauthorization of the medical device user fee program.
Date: 2nd April 2012
CR Investigates: Dangerous medical devices
Most medical implants have never been tested for safety
Consumer Reports magazine: May 2012
Surgical mesh: No testing
In 2007, Janet Holt of Floresville, Texas, felt swelling in her pelvic area. She went to her gynecologist, who told her that her bladder and uterus had prolapsed—dropped out of their normal position within her pelvis. The doctor recommended a hysterectomy and bladder lift.
To read more on this article please click the link below:-
Date: 30th March 2012
Defective Devices, DESTROYED LIVES Loophole Leaves Patients Unprotected from Flawed Devices
Prepared by the office of Congressman Edward J. Markey (D-Mass.)
Date: March 22, 2012
Please click on the link below to view the full PDF document:
www.tvt-messed-up-mesh.org.uk/Medical-Devices-SOUND-Act-Report 3-2012.pdf > >>
Date: 24th March 2012
Victims Speak Out about Dangerous Loophole, Unsafe Medical Devices on the Market
Rep. Markey joined victims, patients, and advocates in a press conference calling for the end of a dangerous loophole at the Food and Drug Administration which has allowed faulty devices to stay on the market.
Direct Link to View on YouTube: youtu.be/qCda6GK0S38 >>>
To view more videos on our website please visit this link:
Date: 24th March 2012
Section of the Harkin/Enzi working draft
Chairman Harkin and Ranking Member Enzi Release HELP Drafts for Stakeholder Discussion
Date: Friday, March 16, 2012
Today the bipartisan working group of Senators Harkin, Enzi, Bennet, Burr, Grassley, and Whitehouse release a bipartisan Drug Supply Chain Integrity Draft: To view the PDF please click on the link at the end of the harkin/Enzi working draft
In addition, Chairman Harkin and Ranking Member Enzi release a bipartisan Medical Device Policy Draft: To view the PDF please click on the link at the end of the harkin/Enzi working draft
These discussion drafts reflect bipartisan efforts to develop consensus policy proposals to accompany the FDA human medical product user fee legislation. The discussion drafts represent just that—draft language that should encourage discussion. These do not represent a completed product, but rather the start of bipartisan work that will hopefully lead to consensus language to be marked up. Our goal is to solicit feedback on the policy merits, potential unintended consequences, and potential opportunities to improve the legislative language. We and our staff anticipate releasing additional drafts in other policy areas in the upcoming weeks. The discussion drafts will be available on the HELP Committee website. Please submit your written comments to both Kathleen Laird (Kathleen_Laird@help.senate.gov) in Senator Harkin’s office and Grace Stuntz (Grace_Stuntz@help.senate.gov) in Senator Enzi’s office by April 1, 2012. Staff will try to meet with as many stakeholders as possible starting March 26, 2012, but will give priority to those that have submitted written comments.
Section of the Harkin/Enzi working draft direct link:
Date: 24th March 2012
J&J Marketed Vaginal Mesh Implant Without U.S. Approval
By David Voreacos and Alex Nussbaum - Mar 21, 2012 10:11 PM GMT
Johnson & Johnson sold a vaginal mesh implant for three years before U.S. regulators approved the device, now the subject of more than 550 lawsuits by women who claim it injured them.
J&J’s Ethicon unit introduced the Gynecare Prolift device in March 2005, touting it in an annual report as an “innovative and effective surgical option” for weakened pelvic muscles. The U.S. Food and Drug Administration said it learned of the Prolift in 2007, when J&J sought approval for a related product. The FDA cleared both devices in May 2008.
Please read and click on the direct link to view more on this article:
Date: 24th March 2012
The Safety Of Unused and New Devices (SOUND Devices) Act
PLEASE SIGN ON TO OUR LETTER!
ANYONE WHO SUPPORTS THE SOUND ACT IS WELCOME TO SIGN ON THE FORM!
Truth in Medicine and its Members Call for Congress to Support
People who want to sign from the United Kingdom please put the state as UK.
Please click on the direct link to view more details:
Date: 1st March 2012
FDA Device Chief Says Approval ‘Loophole’ Needs to Be Closed
The Food and Drug Administration’s top medical-device regulator said the agency needs more power to block unsafe products and prevent repeats of faulty hip implants and vaginal mesh that sparked thousands of patient lawsuits.
House Democrats introduced legislation this month to let the FDA reject devices that have designs based on past products that were recalled for safety flaws. The agency now lacks that authority in many cases, creating a “loophole” that’s challenged the credibility of some device approvals, said Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health.
Click to view on this direct link:
Message to Lana Keeton - USA Thank you for sharing this fantastic News! Well done Dr Shuren!
Date: 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:
Direct Link to website:
Date: 4th February 2012
Truth in Medicine
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:-
Date: 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.
“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.
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 email@example.com; David Voreacos in Newark, New Jersey at firstname.lastname@example.org;
To contact the editor responsible for this story: Reg Gale at email@example.com; Michael Hytha at firstname.lastname@example.org
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
For Immediate Release
GRASSLEY, BLUMENTHAL AND KOHL SEEK TO IMPROVE MEDICAL DEVICE SAFETY
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.
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.
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
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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