Lana Keeton: Patient, Advocate, Victorious!

http://theladyisachamp.blogspot.com

WEDNESDAY, NOVEMBER 28, 2012

MAJOR VICTORY FOR WOMEN AND WOMEN'SHEALTHCARE...PELVIC ORGAN PROLAPSE MESH KITS BITE THE DUST!

Breaking News

Major Victory for Women!

 And for Women’s Health Care!

 Dateline: Miami, 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.

The CDRH will be announcing important new regulations in December. Companies will have to pay an upfront fee of $250,000.00 to be part of a registry along with conducting 3 year clinical trials to prove safety and effectiveness of these “kits” which is not possible and will cost them millions.

And there will be major new requirements for surgeons implanting surgical mesh in the pelvis. No longer will surgeons be able to take a weekend course taught by an industry paid “medical advisor/consultant” to start implanting a filthy petroleum waste by product into women.

Medical mercenaries will now think twice before they mutilate women internally with a foreign body polymer that shrinks, hardens and moves at will within their pelvis mercilessly destroying their lives.

Doctors on the prolapse kit bandwagon who have ignored what they earned in med school about foreign bodies, checked their medical training at the door when they walked into the operating theatre and spouted the ridiculous mantra that foreign body polymers are biocompatible and inert will now be held accountable for their actions. Praise the Lord!!

Just as I was quoted in Bloomberg News in January when the FDA mandated 522 studies of 99 synthetic surgical mesh products used for prolapse and incontinence, industry knows it will not be able to prove these “medical devices” safe or effective and it will cost them millions they are unwilling to spend.

And there it is. It was never about health. It was always about the money, no matter how many millions of people were harmed or put at risk for serious harm or even death.

Now we are seeing the death of insanity in women’s health. Another “Dalkon Shield” bites the dust.

Patients and patient advocates have won a very long and significant battle for the safety of patients who will not be harmed in the future!!

http://www.bloomberg.com/news/2012-01-05/fda-orders-safety-studies-for-vaginal-implants-made-by-j-j-and-c-r-bard.html

FDA Orders Safety Studies for VaginalImplants Made By J&J and C.R. Bard

By Alex Nussbaum & David Voreacos - Jan 5, 2012 3:19 PM CT

           

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 (see FiDA blog dated 11/2/12 High Standards for FDA Leaders? FDA Official Pleads Guilty to Prostitution Charge, Gets One Day of Probation)  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

Lana Keeton testifies 10/2/2010 at Second Annual Truth In Medicine conference, DC  12 minute YouTube video footage.

Consumers Union on Capitol Hill: Real People

Consumers Union

Real People, Real Medical Device Stories:

It’s Time To Include Devices in the FDA’s Sentinel Initiative To Identify Early and Ongoing Problems That Cause Harm

“A few weeks after my elbow prosthesis was surgically implanted, during movement it would make a popping or creaking sound. Four months later, the elbow was blue green and I was in extreme pain. I am now in medical and legal purgatory.”– Steven Baker, Bloomington, MN  

In May 2008, Steven Baker, a proud Air Force veteran and father of two middle school children, had an elbow replacement surgery hoping to regain function and eliminate pain from his right arm that had been damaged in a 2001 work accident. But the implant failed after just four months.

Steven had to undergo “revision” surgery to address the device failure but his extreme pain has persisted and his elbow joint now locks up unpredictably. Steven's health was severely compromised by the revision surgery. He takes maximum dose, long term prescription medication to help mitigate the pain. The pain medication has caused his teeth to rot because of "dry mouth" making eating and talking difficult. And Steven may never be able to get his elbow fixed.

A few thousand elbow replacement surgeries are done each year in the U.S. Patients like Steven with elbow implants require close monitoring and face the prospect of needing to have them surgically removed. Design flaws can cause poor function and other complications for patients, such as dislocation of the device following surgery, joint stiffness and the need for additional surgeries.

Consumers Union urges Congress to adopt the Senate provision of the FDA User Fee Act that includes medical devices in the Sentinel Initiative. Both House and Senate versions of the bill include devices in this important post-market surveillance program. However, the House removes current law that requires the Secretary to use critical information from adverse event reports from people like Steven in the agency’s post-market risk identification and analysis system. We believe this information is critical for monitoring problems with devices on the market and should remain in the law.

For information contact Lisa McGiffert at lmcgiffert@consumer.org

Fodder for TV: The Good Wife highlights failed medical device trial

LINK

Sit down with a glass of wine and experience the medical and legal purgatory of the harmed patient.  This one has a Hollywood ending . . .  The Good Wife  "Get A Room" Season 3 Episode 3

http://www.cbs.com/shows/the_good_wife/video/2149721418/the-good-wife-get-a-room

Congress: Pass Medical Device Safety Bill

LINK

Consumers Union Urges Congress to Adopt Stronger Medical Device Patient Safety June 13, 2012  (FiDA blog bold,underline added)             Washington, D.C. – Consumers Union, the policy and advocacy arm of Consumer Reports, urged House and Senate leaders today to adopt a number of provisions from the Senate’s FDA User Fee Act that would better protect patients from potentially dangerous medical devices than the version passed by the House. The House and Senate are expected to vote on a final version of the legislation before the July 4th congressional recess. Recent safety problems with defective hip implants, defibrillators, and surgical mesh have harmed tens of thousands of patients and underscored the need for stronger federal oversight of these products. “The FDA needs stronger tools to ensure medical devices don’t harm the patients they’re intended to help,” said Lisa McGiffert, director of Consumers Union’s Safe Patient Project (www.SafePatientProject.org).  “The Senate bill does more to enhance the FDA’s ability to better monitor devices once they are on the market and to make it easier to notify patients and require stricter testing when safety problems come to light.  We urge Congress to adopt the stronger patient safety provisions in the Senate bill.” The House legislation does include a number of patient safety measures that were close to the  Senate’s version – adding devices to the post market surveillance Sentinel Initiative and setting a deadline for regulations to be finalized for unique device identifiers.  But in each case, the Senate language is stronger.  Neither the House nor the Senate bill does enough to ensure devices are safe and effective before being cleared by the FDA for the market, according to Consumers Union. Below is the letter Consumers Union sent to the leaders of the Senate Health, Education, Labor, and Pensions Committee and the House Energy and Commerce Committee about the legislation: June 7th, 2012 Dear Chairman Harkin, Ranking Member Enzi, Chairman Upton, and Ranking Member Waxman: Consumers Union, the advocacy arm of Consumer Reports, thanks you for your commitment to ensuring that our national system for approving drugs and devices brings safe products to the market for patient and consumer use. As you move forward in reconciling the differences between the Senate and House versions of the reauthorization of the FDA User Fee Act, please consider our top priorities, presented below: Unique Device Identifier (Senate, Sec. 607) – Support Senate. We see implementation of this current law as soon as possible as a high priority on medical devices. While it is encouraging that both Senate and House versions address finalizing the UDI rule, we support the Senate version because it sets a deadline for implementing UDIs for high risk, life sustaining and implantable devices.  The FDA does not currently have the tools and resources to adequately track and evaluate how patients with implants and other high-risk devices are faring.  Effective post-market surveillance is dependent on having UDI in place – that includes effective use of the Sentinel Initiative, device registries, and the ability to more precisely identify problems and inform patients when problems with devices are identified. Five years ago, Congress mandated the creation of UDIs when the last user fee agreement was reauthorized — setting a timeframe for implementing this system is critical to patient safety in the future. Reclassification procedures (Senate, Sec. 601) – Support Senate. The ability to create an expedited process to more appropriately reclassify devices is a tool the FDA needs in this fast-paced market. Our specific interest is in the ability to up-classify devices that have caused serious harm to patients so that similar device applications in the future will require more scrutiny of their safety. This provision does not allow expedited reclassification without cause – it must be based on new information that the agency receives about the particular device. The process outlined in the Senate version strikes the appropriate balance between providing sufficient due process for manufacturers and input from all stakeholders AND protecting patient safety. We remain concerned that this also empowers FDA to down-classify devices more quickly. While the companies will resist down-classification of devices where they have invested resources in taking a device through premarket approval, we have seen worrisome examples of down-classification of devices that then go through the De Novo process. We look forward to working with Congress to make sure that this provision works as intended to facilitate moving improperly classified devices to an appropriate classification. The Senate requirement for an annual report will help to monitor the use of this new process. Investigational device exemption – Oppose House Sec. 701, Support Senate Sec. 606. Retaining FDA’s full range of options in approving IDEs is essential to public health in general as well as the health of the specific patients involved in device clinical trials. The Senate version gives the Secretary authority to put a hold on studies that pose unreasonable risks to their subjects. This allows a time out for re-evaluation and then allows the research sponsors to make adjustments or provide more information to address concerns and resume the study. The House version would tie the hands of the FDA, limiting FDA’s ability to reject IDE applications based on the likelihood of approval. The FDA has a specific responsibility to ensure that the clinical studies done to investigate new devices are worth the risk to the subjects involved and to ensure that the many more people who would be exposed to a device post clearance or approval are not put at risk. If the FDA realizes an investigation will not support approval, patients ought not be exposed unnecessarily to risks associated with the investigation. Timeline for Post-market surveillance studies (Senate, Sec. 603) – Support Senate. We strongly support expeditious completion of 522 studies ordered by the Secretary due to concerns about the safety of devices, typically based on reports to the FDA about patient harm. Until these ordered studies are completed, doctors continue implanting them in patients and future users of the devices are endangered. It is essential that these studies about the safety of devices be done in a timely manner.  The Senate bill requires these studies to begin not later than 15 months after being ordered. Consumers Union specifically advocated for timelines for these studies to be tied to the initial Secretary’s order and urges its inclusion in the final bill. Sentinel (Senate, Sec. 604; House, Sec. 762) – Support Senate. We strongly support adding medical devices to the Sentinel Initiative and appreciate that both the House and the Senate included devices in this important post-market surveillance tool. The House version is comparable to the Senate except that it strikes a section that requires the Secretary to include reporting data of serious adverse drug experiences and events — including those submitted by patients, health care providers, and manufacturers – in the post-market risk identification and analysis system. This House language would eliminate critical information from the agency’s post-market oversight of drugs (and devices as added in both versions of the bill) and should not be removed from current law. Condition of Approval Studies (Senate, Sec. 602) – Support Senate. The Senate bill codifies a current practice that allows the FDA to require approval for high-risk devices to be contingent on completing specified post market studies. This clarifies that the Secretary can impose civil monetary penalties on companies that fail to complete these studies and will level the playing field for companies that do comply with such requirements. Thank you for your work on this important legislation. If you have any questions about the above recommendations, please don’t hesitate to contact us. Lisa McGiffert Director, Safe Patient Project

Smarmy corporate action: surgical mesh

http://www.nytimes.com/2012/06/06/business/johnson-johnson-unit-will-stop-selling-urinary-implants.html?emc=tnt&tntemail1=y

June 5, 2012

Johnson & Johnson Unit to Halt Urinary Implants

By KATIE THOMAS  New York Times  (FiDA blog bold)

Johnson & Johnson’s Ethicon division will stop selling four types of mesh implants used to treat urinary incontinence, the company announced in a letter to judges overseeing two large groups of lawsuits filed by women who claim the devices caused serious injury.

In a statement Tuesday, the company stressed that the move was not a recall, but was based on the products’ commercial viability “in light of changing market dynamics, and is not related to safety or efficacy.”

The announcement comes after years of controversy over the implants, which are used to treat incontinence caused by muscle weakening and a condition called pelvic organ prolapse, in which organs descend and press against the vaginal wall. The devices have been linked to serious injuries in women, including infections, pain and other complications. In 2008, the Food and Drug Administration warned that use of the implants was associated with complications but that the problems were rare. But between 2008 and 2010, the agency reported a fivefold increase in reports related to the use of the devices. In January, the F.D.A. ordered makers of the implants to study their risks in patients.

“This is very good news for women because it takes several products off the market that have harmed a lot of women,” said Diana Zuckerman, president of the National Research Center for Women and Families, a public health advocacy group. However, she said, “the bad news is that there are many other surgical meshes still on the market that are just as dangerous.”

Other device makers that also sell surgical mesh products include Boston Scientific, C. R. Bard and W. L. Gore & Associates. In a statement, a spokeswoman for Boston Scientific said the company believed that using such products “is and remains an important treatment option for patients.”

The four products Ethicon will discontinue are the Gynecare TVT Secur system, the Gynecare Prosima, the Gynecare Prolift and the Gynecare Prolift+M. Ethicon will stop selling the products over the next three to nine months, with a goal of ending sales worldwide by the first quarter of 2013. A spokesman for Ethicon declined to say how many women were implanted with the products.

Johnson & Johnson has undergone a series of product withdrawals and recalls in recent years, including the recall of artificial hips, contact lenses and other products, and the recent decision to end its line of drug-coated heart stents.

Surgical mesh medical implants: FDA requires post-market data

Post-market data will help reduce risk to patients

Congratulations to Lana Keeton and Truth in Medicine (blog cited on right column) for tenacity and diligence leading to federal public policy changes that will elevate safety and effectiveness of U.S. medical devices and will make jobs in that industry more stable and respected.

Medical Device Double Jeopardy?

Link to NEJM here. Breast Implant disappears during Pilates exercise.

This very brief article remarks upon treatment of a Maryland woman who had breast implant prosthesis (breast cancer).  She reported that her breast implant was swallowed into her body and disappeared.  The medical providers located the implant and added surgical mesh!  

Surgical mesh is a medical device that is being questioned for its' safety and effectiveness, yet surgeons continue to implant it into unsuspecting patients. www.truthinmedicine.us.com

What protections will she be provided if the surgical mesh proves to be a problem rather than a solution?  That is what Congress is responsible for determining:  right now, the charter of the FDA disallows patient stakeholder voting rights, there is no independent, accessible post-market data registry and legal protections unfairly favor the medical provider and medical device industry.   Patients beware!

Public Citizen Failed implanted medical device - Surgical Mesh

(link here) Public Citizen advocates for recall of surgical mesh. Bravo!
Lives have been destroyed by this product and the industry's deafness to patient concerns.

Surgical mesh - another failed product of the medical device industry.

I heard it described that it is "as if you have a cheese grater implanted in you"  your tissues are grated.  Such pain and horror!  This must stop.

Implanted surgical mesh - GAO to FDA "compromising patient safety"

LA Times story: FDA & surgical mesh adverse events (link here)

Lana Keeton is an activist.  Her mission is to make medical device manufacturers (implanted surgical mesh) accountable for their failed "innovations" and to protect patients by making FDA data transparent/objective and available to the public.

Truth in Medicine - Lara Keeton

Surgical Mesh: a video by Truth In Medicine (link here)