Lana Keeton and Truth in Medicine - Advancing Patient Safety in the Nation’s Capitol
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 last Wednesday, March 28th in Washington, D.C. at the MDUFA III public meeting in advance of re-authorization by Congress this fall.
Lana Keeton was an invited FDA panel member at the FDA Public Workshop on the Medical Device User Fee Program. The FDA is eager to seek funding for the next five years of medical device reviews beginning on October 1 2012. Keeton reminded those in attendance that the agency needs the ability to put patient safety first.
“The MDUFA hearings aren’t talking about patient safety. It’s nowhere to be found,” says Keeton. The patient advocate spoke on behalf of patients along with Kate Ryan of the National Women’s Health Network and Paul Brown of the National Research Center for Women & Families.
The medical device industry has offered to double its funding of MDUFA to $595 million for the next five years beginning next fiscal year in exchange for heightened cooperation from the federal agency to bring medical devices to market faster.
Keeton was tough when she reminded the assembled group that that money is a drop in the bucket when compared to the $350 billion in annual revenues of the medical device industry and by what it spends to influence doctors and medical associations, to pay foundations, lobbyists, ghostwriters, in criminal fines to the Department of Justice and lastly to injured plaintiffs and their attorneys.
Given the current system, Keeton says Americans are not safe in light of industry’s goal to protect the profits of their companies.
“I am here to speak for patient stakeholders who do not have a voice, who are sick and injured and disabled, some who are already dead and some who would welcome death not to be in pain anymore.”
Keeton adds that when patients, sick from mesh, go to their doctors to be well often “what happens to them is despicable.”
She reminded the gathered group of her own experience with a piece of Prolene polypropylene mesh that led to infections, 17 surgeries and one still ahead this summer to remove the final 4 inch portion of Prolene mesh. Keeton says, “My bladder is now worth about a million dollars from medical treatment and lawsuits. A stark contrast to the approximate $1,200.00 the hospital paid to purchase the device from Ethicon in 2001.”
Keeton and Truth in Medicine’s Regulatory Affairs Director, Janet Holt, continue to call for clinical trials for all permanently placed medical devices be done before implanted into patients; patient labeling for all medical devices; for a patient registry for all permanently implanted medical devices so patients can make an informed decision and have the ability to track complications.
Keeton told the crowd, “To make Americans safe, we must properly fund and properly man and give the best regulatory authority possible to one of the most important institutions in the American government, the FDA. The House of Representatives and the Senate and the President of the United States have to stop using the FDA as a political football. They have to come together in unity to do their most important job: protect the public health!”
Lana Keeton has been invited to discuss “Synthetic Surgical Mesh: The Gold Standard?” as a medical device expert at Mass Torts Made Perfect, at the Wynn Hotel in Las Vegas, April 18-20, 2012.
Keeton will tell the group of assembled trial attorneys how medical marketing masquerades as “published studies and clinical trials,” and debunk the myth of doctor error as a leading cause of synthetic surgical mesh complications. Keeton says lawyers need to understand how important it is to properly file an FDA notification of client injuries, something the FDA cannot under law ignore when the numbers meet a critical mass.
Keeton believes the culture must change regarding devices and patient safety. The silence enforced on patient clients while they are in a lawsuit perpetuates the failures of the system. The harm suffered by these patients has to be reported to the FDA to stop others from being injured.
“Publicize yourself as the patient advocate and protector to your clients that you are. Attorneys, not doctors, not Industry and not the FDA, are sounding the alarm direct to injured patients through television commercials while industry is still covering up the harm to everyone: the FDA, patients, doctors and hospitals.”
Keeton will appear Friday, April 20, 2012, during the 9:30 a.m. session on Pelvic Mesh: How to Represent the Victims, along with Robert Price of Levin Papantonio Thomas Mitchell Rafferty & Proctor, Amy Eskin of Hersh & Hersh, and Henry Garrard of Blasingame Burch Garrard Ashley.
Lana Keeton as the Founder of Truth in Medicine has also been asked to be a guest lecturer for a course at the University of Texas, Austin in the January 15 through February 19th session of UT Quest at the Osher Lifelong Learning Institute. www.utquest.org. She is being asked to share her knowledge as a medical device expert and patient advocate on the inner workings of the medical device industry and the FDA and the failures that are leaving thousands of innocent patients injured.
“We are at a critical juncture of patient safety in a standoff with the muscle of industry marketing. I’m committed to making sure that the patient’s voice is not lost in this struggle,” Keeton says.
TRUTH IN MEDICINE PRAISES FDA FOR MESH WARNING, CALLS FOR END TO SYNTHETIC MESH USE
Following years of persistent communication from the patient advocacy group, Truth in Medicine, the federal agency that oversees medical devices issued its second strongly worded warning about the dangers of surgical mesh. Truth in Medicine feels there is still more important work ahead in removing mesh from the market except in rare cases. Truth in Medicine is also calling for doctors and professional associations to recommend to their members to avoid the use of synthetic mesh whenever possible, whether for hernia repair, pelvic organ prolapse or bladder suspension.
The Food and Drug Administration (FDA) in its July 13 advisory admits that petroleum-based meshes, which are the medical devices implanted in women to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI), causes at least 10% more complications than previously thought and is exposing patients to unnecessary risks such as pain, bleeding and infection.
“The added benefit of using the mesh is not evident, but there certainly appears to be an added risk,’’ said Dr. William Maisel, Food and Drug Administration’s (FDA) chief scientist and deputy director of the center for devices. Lana Keeton had a surgically implanted mesh which failed and led to years of devastating pain and repeated removal surgeries.As a steel broker she understood the physical and chemical properties of steel, translated it to synthetic surgical mesh, and combined it with her ability to research to become a patient advocate founding Truth in Medicine in 2008. With thousands of contacts from injured patients worldwide, the group has been persistent in its calls to the FDA, through face-to-face meetings, and in testimony at public hearings, a driving force that led the FDA to issue this second public warning.
“We’ve been talking to them since ‘07 and we’re not going away. Our public pressure has been instrumental in raising the awareness of enormity of the problem,” said Keeton. “Ultimately there is no added value to synthetic surgical mesh and a huge downside” said Keeton who would like the FDA to recall the medical device from the market. Keeton recommends doctors follow the lead of Dr. Shlomo Raz, world renowned UCLA pelvic floor repair specialist and Professor of Urology who presented his non-mesh procedure for suture only pelvic organ prolapse repair at the American Urological Association (AUA) in May of this year.
The FDA reported that between 2008 and 2010 there were 1,500 adverse event reports of mesh complications, a number that increased 50% from the prior three years. More than 75,000 women had mesh implanted for pelvic organ prolapse last year and approximately 200,000 had mesh surgery for incontinence, though the warning issued July 13 only addresses mesh implanted for POP surgeries.
Most women experience pain and bleeding within a year after their surgery. Patients often must undergo multiple surgeries to remove the mesh which Keeton says is like cutting gum out of your hair. “Any complication is devastating,” says Keeton who knows from personal experience having endured 17 procedures/surgeries to remove the mesh placed in her in 2001. Dr. Maisel, the FDA scientist, said the traditional surgery performed by a skilled, experienced surgeon using stitches only may be a better alternative for women suffering from POP and SUI. Manufactured by at least nine different companies, “plastic” mesh is used to reinforce the pelvic organs in a patient suffering from incontinence and/or prolapsed organs. Surgeons typically insert the mesh through the vagina, though some surgeons prefer placement through an incision in the abdomen. The agency is reviewing the use of mesh for incontinence and will hold a two-day meeting in September to determine if there is any benefit to synthetic surgical mesh and whether it should be reclassified from a low to a high-risk device. Synthetic surgical mesh is considered to be low-risk. “Something that is implanted in your body permanently can never be considered low-risk” says Keeton who also points out that the agency is currently reassessing the controversial 510 (k) clearance process that allows untested, unsafe medical devices on the market. A manufacturer only need claim that a similar “predicate” device is already on the market to obtain clearance for a new medical device. In the case of surgical mesh, the predicate device for all current bladder suspension meshes was taken off the market after it was found to be “adulterated and misbranded” and led to problems such as vaginal erosion or dehiscence and did not appear to function as intended. The FDA does not require the agency to re-review the medical mesh currently on the market that used the recalled mesh as a predicate device.
The 510 (k) fast-track system has gone largely unchanged since the 1970s.#
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