Press and Media Worldwide

updated 4th February 2012
Bill Would Require More Monitoring of Implants‏
By BARRY MEIER
Published: December 14, 2011

Amid growing problems with artificial hips and other medical implants, bipartisan legislation was introduced in the Senate on Wednesday that would force manufacturers to track the performance of such products after they were approved for sale.

The bill would allow the Food and Drug Administration to compel companies to track implants, such as replacement hips, that belong to a category of products that do not require human testing for approval.

The proposal is an effort to address longstanding complaints by patient advocates and others like the Institute of Medicine about a system known as the 510(k) process that the F.D.A. uses to clear the sale of certain implants like artificial joints. To sell a new product under that system, a producer need only show that it is “substantially similar” to a product already on the market.

Thousands of the all-metal hips that are now failing prematurely in patients were approved through the 510(k) system. The new proposal would not require added premarket testing of such implants but would broaden the F.D.A’s postapproval oversight by giving it the authority to mandate that companies collect data on device performance. The bill, if adopted, would also tighten federal scrutiny of product recalls.

The bill was sponsored by two Democrats, Herb Kohl of Wisconsin and Richard Blumenthal of Connecticut, and a Republican, Charles E. Grassley of Iowa. In a telephone interview, Mr. Blumenthal said that the legislation would enhance patient safety without slowing device approval. He called the all-metal hips a “classic example” of why such monitoring was needed.

“There is clearly a need for scrutiny once products are implanted or used on patients,” he said.

A wave of recently introduced bills backed by the medical device industry would “streamline” F.D.A. rules to allow new products to reach market more quickly. And while the bill introduced Wednesday most likely faces an uphill fight, it may serve as a negotiating chip in a Congressional debate next year over F.D.A. device regulation.

A spokeswoman for the F.D.A., Karen Riley, said that the Obama administration had not taken a position on the bill. Wanda Moebius, a spokeswoman for a device industry trade group, the Advanced Medical Technology Association, said the group had not seen the bill but added that studies had shown that the current 510(k) approval process was “remarkably safe.”

Along with introducing the bill, the three senators sent letters Wednesday to five major producers of medical devices seeking documents about how they track product safety and recall devices.

The companies were Johnson & Johnson, an artificial joint maker; Zimmer Holdings, another producer of artificial joints; Medtronic, a heart and spinal implant producer; Boston Scientific, a heart device maker, and C. R. Bard, a surgical implant maker.

Specifically, in the case of Johnson & Johnson, Congressional investigators want to know when the company was warned that one of its all-metal hips — the A.S.R., or Articular Surface Replacement — was failing and how it tracked those problems. Last year the DePuy division of Johnson & Johnson recalled the device after it had been implanted in some 93,000 patients worldwide, including 40,000 in this country.

As of early October, about 3,500 lawsuits have been filed against Johnson & Johnson in connection with the A.S.R., and studies here and abroad suggest that the A.S.R. may have already failed a few years after implant in more than twice that number of patients here. Artificial hips are supposed to last 15 years or more before requiring replacement.

Last month, a legislative panel in Australia issued a report that concluded that Johnson & Johnson was probably aware of serious problems with the A.S.R well before recalling it. The panel also characterized the company’s responses to its questions as “decidedly opaque.”

“Many people could have avoided considerable pain, suffering and diminished quality of life if the company had acted in a responsible manner to known problems with these devices,” the Australian report stated.

In a statement, a spokeswoman for DePuy, Mindy Tinsley, said, “We believe we made the appropriate decision to recall at the appropriate time given the available information.”

A version of this article appeared in print on December 15, 2011, on page B10 of the New York edition with the headline: Bill Would Require More Monitoring Of Implants.

Source:www.nytimes.com/2011/12/15/business/bill-would-require-more-monitoring-of-implants.html?_r=2&scp=1&sq=medical%20devices&st=cse >>>

updated 4th February 2012
Take Action with Truth in Medicine and Consumers Union!!
and....Democrats Call for Congressional Hearing on Lap Bands and Vaginal Mesh!!
By Lana C. Keeton‏
HELLO EVERYONE....THERE'S LOTS HAPPENING!!!...the genie is out of the bottle and device makers can not put him back in! Truth in Medicine agrees Synthetic Surgical Mesh and Lap Bands should be investigated by Congress for the serious complications (and deaths!) caused by these overused, misused, unsafe medical devices. Please click on the link below to read more:- www.tvt-messed-up-mesh.org.uk/truth-in-medicine-take-action-with-truth-in-medicine-and-consumers-union.html >>>

updated 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 >>>

21st December 2011
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! 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 >>>

Article in the New York Times Newspaper. Women Sue Over Device to Stop Urine Leaks Amber Suriani, with her daughter, Sabrina. Ms. Suriani is a plaintiff in a lawsuit over obtape, a treatment for urinary incontinence in women.
www.nytimes.com/2009/05/05/health/05tape.html?ref=health

http://www.msnbc.msn.com/id/27323060/ MSNBC News - Incontinence surgery linked to complications 1,000 reports of problems from mesh used in surgeries, officials say

http://www.cbc.ca/health/story/2008/10/22/surgical-mesh.html CBC News - Surgical mesh tied to complications in women

http://www.wsmv.com/news/18159640/detail.html WSMV News - Woman Suffers Surgery Complications Medical Mesh Left Her Nearly Unable To Walk

http://www.wnem.com/video/18019557/index.html WNEM News I-TEAM: Painful Medical Practices. If you've ever had a hernia repaired, chances are you have a piece of surgical mesh inside your body that could be doing more harm than good. Note: Please allow the advert to run at the begining then you can view the stories.

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 >>>

www.justnews.com/video/17492050/index.html Lana's video on Surgeries Using Synthetic Mesh Could Have Adverse Reactions. Surgical procedures using synthetic medical mesh implants could have an adverse reaction on some patients. At the begining of the video there is an advert, please let the advert roll when video starts, then you can hear Lana's story.

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 >>>