Joint replacements are the #1 expenditure of Medicare. The process of approving these medical devices is flawed according to the Institute of Medicine. It is time for patients' voices to be heard as stakeholders and for public support for increased medical device industry accountability and heightened protections for patients. Post-market registry. Product warranty. Patient/consumer stakeholder equity. Rescind industry pre-emptions/entitlements. All clinical trials must report all data.
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Monday, June 30, 2014

Catastrophically harmed by surgical mesh? Justice in settlements?


By: Austin Kirk | Published: June 25th, 2014
As hundreds of Coloplast mesh lawsuits continue to move forward through the federal court system, the parties are continuing to make progress in settlement negotiations to resolve the litigation, according to a recent court update.
Coloplast Corp. currently faces nearly 1,500 federal transvaginal mesh and bladder sling lawsuits, which have all been consolidated for pretrial proceedings before U.S. District Judge Joseph R. Goodwin in the Southern District of West Virginia as part of an MDL, or multidistrict litigation.
All of the complaints involve similar allegations that women suffered severe and debilitating complications after receiving Coloplast mesh for surgical repair of pelvic organ prolapse (POP) or female stress urinary incontinence (SUI), where the mesh eroded through the vagina, caused infections or other injury.
According to a pretrial order (PDF) issued by Judge Goodwin on June 16, “substantial progress” has been made toward settling the Coloplast cases and a follow up status conference has been scheduled for August 7, at which time the parties will meet with Judge Goodwin in chambers to provide an updated report.
In March, it was reported that a Coloplast mesh settlement was reached to resolve about 400 cases for $16 million.
In addition to lawsuits against Coloplast, Judge Goodwin is also presiding over thousands of similar cases brought against manufacturers of other transvaginal mesh products, including C.R. Bard, American Medical Systems (AMS), Ethicon, Boston Scientific, Cook Medical and Neomedic.
Endo Health Systems reported last month that it has agreed to pay $830 million to settle AMS mesh lawsuits brought by about 22,000 women, making it the largest settlement reported to date in the litigation.
C.R. Bard has also reached a number of individual settlements involving cases that were scheduled to come up for trial, but no global settlement agreement has been reached.
Vaginal Mesh Litigation Update
According to the latest case list (PDF) released by the U.S. Judicial Panel on Multidistrict Litigation (JPML) on June 16, Judge Goodwin is currently presiding over 17,812 AMS mesh lawsuits, 18,176 Ethicon mesh lawsuits, 12,004 Boston Scientific mesh lawsuits, 8,555 Bard Avaulta mesh lawsuits, 1,468 Coloplast mesh lawsuits, 195 Cook Medical mesh lawsuits and about 52 Neomedic mesh lawsuits.
The combined total of 58,262 vaginal mesh claims pending in the federal court system represents a nearly 35% increase in the number of cases pending since March 2014, when the U.S. JPML reported that a combined total of 43,173 cases were centralized before Judge Goodwin. In addition, thousands of other cases are pending in various state court systems throughout the country.
As part of the coordinated pretrial proceedings in federal court, Judge Goodwin has scheduled a series of early trial dates involving several of the manufacturers. Known as “bellwether” cases, such test trials are designed to help the parties gauge how juries may respond to certain evidence and testimony that may be repeated throughout the litigation.
In August, a trial involving a lawsuit filed against Ethicon by Jo Huskey is scheduled to go before a federal jury. Huskey alleges that she suffered injuries after receiving an Ethicon TVT-O bladder sling for stress urinary incontinence.
Later this year, a combined trial involving 11 Boston Scientific mesh cases is set to go before a jury starting in October 2014. That case involves women who experienced problems after receiving a Boston Scientific Obtryx sling for repair of stress urinary incontinence.
Last year, a series of three Bard Avaulta trials were set for trial in the MDL, with the first case going before a federal jury in July 2013, involving a lawsuit filed by Donna Cisson. That trial resulted in a $2 million damage award against Bard, including punitive damages designed to punish the company for the actions during the manufacture and sale of the product. The second and third trials were each settled shortly before they were set to begin, with terms of the deals withheld.
Given the lack of progress towards settling additional cases by some manufacturers, Judge Goodwin recently ordered that a second wave of Bard Avaulta cases and Boston Scientific mesh cases be prepared for trial, with hundreds of cases going through case-specific discovery over the remainder of this year so that they can be trial-ready by early 2015.
If the manufacturers fail to reach vaginal mesh settlements to resolve the majority of cases against them, they could face hundreds of individual trial dates scheduled throughout the country next year.
Related Articles


- See more at: http://www.aboutlawsuits.com/coloplast-mesh-settlement-update-66621/#sthash.6t8X8Wjf.dpuf

Friday, June 27, 2014

Submit your public comments about Morcellation Devices NOW! Here's how:

http://www.fda.gov/advisorycommittees/calendar/ucm400221.htm

July 10-11, 2014: Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee Meeting Announcement
Center
Date
Time
Location
CDRH
July 10-11, 2014
8:00 a.m. - 6:00 p.m.
FDA White Oak Campus
10903 New Hampshire Ave.
Building 31 Conference Center, the Great Room (rm. 1503)
Silver Spring, MD 20993-0002

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-N-0736]
Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

AGENCY:  Food and Drug Administration, HHS.
ACTION:  Notice.
This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA).  The meeting will be open to the public.
Name of Committee:  Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee.
General Function of the Committee:  To provide advice and recommendations to the Agency on FDA's regulatory issues.
Date and Time:  The meeting will be held on July 10 and 11, 2014, from 8 a.m. to 6 p.m.
Location:  FDA White Oak Campus, 10903 New Hampshire Ave., Building 31 Conference Center, the Great Room (rm. 1503), Silver Spring, MD 20993-0002. Information regarding special accommodations due to a disability, visitor parking, and transportation may be accessed at:  http://www.fda.gov/AdvisoryCommittees/default.htm; under the heading "Resources for You," click on "Public Meetings at the FDA White Oak Campus."  Please note that visitors to the White Oak Campus must enter through Building 1.
Contact Person: Shanika Craig, Shanika.Craig@fda.hhs.gov, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD  20993, 301-796-6639, or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area).  A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice.  Therefore, you should always check the Agency's Web site at http://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate advisory committee meeting link, or call the advisory committee information line to learn about possible modifications before coming to the meeting.
Agenda:  On July 10 and 11, 2014, the committee will discuss the safety of laparoscopic power morcellator devices as it pertains to their potential to disseminate and upstage a confined, but undetected (occult) uterine malignancy during laparoscopic hysterectomy or myomectomy. FDA is convening this committee to seek expert scientific and clinical opinion on the risks and benefits of these types of devices when used for these procedures, based on available scientific data. The committee will make recommendations regarding the appropriate use, premarket testing, labeling, and other risk mitigations (including the use of containment bags) for these devices. 
On July 11, 2014, during the afternoon session, the committee will also be asked to discuss the regulatory classification of laparoscopic power morcellator devices when used to cut and extract tissue during gynecologic laparoscopic procedures and to assist FDA in determining the appropriate level of regulatory control necessary for this device type, including discussion of class II (special controls) or reclassification to class III (subject to premarket approval application (PMA)).
FDA intends to make background material available to the public no later than 2 business days before the meeting.  If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA's Web site after the meeting.  Background material is available at http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/default.htm. Scroll down to the appropriate advisory committee meeting link.
The Center for Devices and Radiological Health (CDRH) plans to provide a live webcast of the July 10 and 11, 2014, meeting of the Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee.  While CDRH is working to make webcasts available to the public for all advisory committee meetings held at the White Oak campus, there are instances where the webcast transmission is not successful; staff will work to reestablish the transmission as soon as possible.  The link for the webcast is available at: https://colaboration.fda.gov/obgyd/, or further information regarding the webcast, including the Web address for the webcast, will be made available at least 2 days in advance of the meeting at the following Web site: http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/ObstetricsandGynecologyDevices/default.htm.  Select the link for 2014 Meeting Materials.
Procedure:  Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee.  Written submissions may be made to the contact person on or before June 24, 2014. Oral presentations from the public will be scheduled between approximately 9 a.m. and 10 a.m. for both days of this meeting.  Those individuals interested in making formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before June 16, 2014.  Time allotted for each presentation may be limited.  If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session.  The contact person will notify interested persons regarding their request to speak by June 19, 2014.
FDA will work with the manufacturers of laparoscopic morcellators and containment bags who wish to make presentations to ensure that adequate time, separate from the approximate time slots for the general open public hearing session, is provided.  Manufacturers interested in making formal presentations to the committee should notify the contact person on or before June 18, 2014.  Manufacturers with common interests are urged to coordinate their oral presentations.
FDA is opening a docket for public comment on this document.  The docket number is FDA-2014-N-0736.  The docket will close on August 11, 2014.  Interested persons are encouraged to use the docket to submit electronic or written comments regarding this meeting.  Submit electronic comments to http://www.regulations.gov.  Comments received on or before July 1, 2014, will be provided to the committee for their consideration. Comments received after July 1, 2014, will be taken into consideration by the Agency.
Submit written comments to the Division of Dockets Management, Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD  20852.  It is only necessary to send one set of comments.  Comments are to be identified with the docket number found in brackets in the heading of this document.  Received comments may be seen in the Divisions of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday and will be posted to the docket at http://www.regulations.gov
Persons attending FDA's advisory committee meetings are advised that the Agency is not responsible for providing access to electrical outlets.
FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact AnnMarie Williams, at Annmarie.Williams@fda.hhs.gov, or 301-796-5966, at least 7 days in advance of the meeting.
FDA is committed to the orderly conduct of its advisory committee meetings.  Please visit our Web site at http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures on public conduct during advisory committee meetings.
Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2).
Dated: June 3, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
 






Thursday, June 26, 2014

Please Sign this Change.org Petition to Restrict Uterine Power Morcellation

FDA hearing July 10 & 11 (deadline)
By JANE E. BRODY MARCH 17, 2014 12:01 AM
Jane Brody on health and aging.
Many patients assume that, like prescription drugs, surgical procedures and instruments undergo extensive testing and must be government-approved. It’s not necessarily so.
Developers, of course, do test new instruments, and practitioners often train with an expert before using them unsupervised to treat patients. And the Food and Drug Administration must confirm an instrument’s safety and effectiveness before it can be marketed — but only if the device is deemed significantly different from others already approved.
Surgical techniques, however, are not subject to the stringent approval process that drugs go through. And as with drugs, problems with new procedures may not become apparent until after they have been used many hundreds or thousands of times.
Such is the case with a popular treatment for a very common medical problem: uterine fibroids. The technique, called electric or power morcellation, has widespread appeal for both surgeons and patients. It is used during laparoscopic or robotic-assisted operations that are fast and effective, require only a tiny incision or none at all, and involve less pain, a shorter hospital stay and a quicker recovery. In most cases, these operations are safer than traditional surgery.
As recent reports have shown, however, power morcellation can also cause serious and sometimes life-threatening complications. Experts say that prospective patients are often not told about these risks before consenting to the operation.
The technique involves insertion of a tiny instrument with a rapidly rotating blade, the morcellator, that breaks up the fibroid so that it can be sucked out through the small opening of a laparoscope. But problems can arise months or years later if pieces of tissue escape into the pelvic cavity and seed themselves on other organs.
This problem is all the more serious if the fibroid that was morcellated happens to have contained a hidden cancer. Although the overwhelming majority of fibroids are benign, there is no certain way to tell before their removal if they harbor a cancer, which happens in 1 in 400 to 1 in 1,000 cases.
One such case involves a 41-year-old Bostonian, Dr. Amy J. Reed, an anesthesiologist and a mother of six, who now has a Stage 4 leiomyosarcoma after undergoing uterine morcellation. It is a rare but particularly aggressive uterine cancer. Dr. Reed and her husband, Dr. Hooman Noorchashm, a cardiothoracic surgeon, are waging a campaign through Change.org to halt use of the technique.
Despite several preoperative tests, neither Dr. Reed nor her surgeon suspected that cancer lurked within the fibroids that were removed. If she had had a traditional operation in which the fibroids were cut out or the entire uterus removed intact, it is highly unlikely that the cancer would have spread.
From 1983 through 2010, 13 unexpected uterine sarcomas were reported after uterine surgery on 5,666 patients. Among 1,192 women who underwent morcellation, two developed sarcoma that spread within the abdomen.
After reviewing the medical records of more than 1,000 women who received morcellation for fibroids, specialists at Brigham & Women’s Hospital in Boston found a ninefold higher rate of unexpected sarcoma than is now quoted to patients considering the procedure.
“These data suggest uterine morcellation carries a risk of disseminating unexpected malignancy with apparent associated risk of mortality much higher than appreciated currently,” the researchers wrote in the journal PLOS One in 2012.
Even benign uterine tissue, when it is spread to other parts of the abdomen during morcellation, can grow in places it doesn’t belong and cause pain, infection or bowel obstruction.
There is a technique that could make morcellation safer: encasing the tissue to be removed in a bag before it is broken up. But thus far, the procedure is infrequently used, and few surgeons are skilled in the technique.
Other established ways to treat bothersome fibroids are free of this potential risk, though complications like wound infection are possible.
Fibroids are extremely common, affecting half or more women during their reproductive years, when hormones foster their growth. They develop from the smooth muscle tissue of the uterus, ranging in size from tiny to huge, and often shrink after pregnancy and menopause.
Most women with fibroids are unaware they have them, but others can experience symptoms like prolonged heavy periods, bleeding between periods, pelvic pressure, constipation, frequent urination, backaches and anemia. They can sometimes cause infertility or miscarriage.
Fibroids are typically detected through a pelvic exam, sonogram or M.R.I., sometimes with saline solution or a dye used to better define their size and location.
Nothing needs to be done about a fibroid that causes no distress. Large, bothersome fibroids can often be shrunk by several months of treatment with medications that block estrogen and progesterone, causing temporary menopause and its attendant symptoms.
The drug mifepristone (RU-486) also can shrink fibroids, and Evista may do likewise, but only in postmenopausal women. Sometimes a low-dose oral contraceptive is used to reduce bleeding caused by fibroids without shrinking their size.
Noninvasive ultrasound surgery under M.R.I. guidance can be used to heat and destroy a fibroid without damaging the uterus. A fibroid also can be destroyed by injecting small particles into uterine arteries to cut off its blood supply.
Fibroids can be removed laparoscopically or robotically without damaging the uterus. If the fibroid is contained within the uterus, it can often be removed with surgical instruments inserted through the vagina and cervix. Some fibroids may be destroyed by applying heat or electric current to the uterine lining.
Very large, multiple or deep fibroids may require more traditional surgery, called an abdominal myomectomy, that spares the uterus, or with a hysterectomy, a more serious operation involving removal of the entire uterus, ending a woman’s menstrual periods and ability to bear children.
If you are contemplating treatment for symptomatic fibroids, your doctor should answer several important questions before you choose a method:
What is the nature of the problem, and how necessary is it to treat it?
What procedures are known to be effective, and what are the risks and benefits of each?
What is the approach you recommend, and how much experience do you have with it?
What are its possible complications, and how often do they occur?
Without a clear understanding of treatment options, their potential hazards as well as their effectiveness, it is not possible to for you to give informed consent.

http://en.wikipedia.org/wiki/Morcellator
Morcellator
From Wikipedia, the free encyclopedia

Jump to: navigation, search
A morcellator is a surgical instrument used for division ("morcellation") and removal of large masses of tissues during laparoscopic surgery.[1] It can consist of a hollow cylinder that penetrates the abdominal wall, ending with sharp edges[1] or cutting jaws,[2] through which a grasper can be inserted to pull the mass into the cylinder to cut out an extractable piece.[1][2]

Morcellation devices in surgery[edit]
Laparoscopic morcellation is commonly used at surgery to remove bulky specimens from the abdomen using minimally invasive techniques. Historically, morcellation was performed using a device that required the surgeon or assistant to manually 'squeeze' the handle. Other reports describe using a scalpel directly through the abdomen to create small specimens that can be drawn out of the abdominal cavity. In 1993, the first electric morcellator was introduced in the US market. It was initially used for uterine extraction, but later applied to other organs. The use of morcellators at surgery has now become commonplace, with at least 5 devices currently on the US market. Despite decades of experience, there remains limited understanding of the short-term and long-term sequelae of morcellation. Concerns have been raised about injury to surrounding organs including bowel, bladder, ureters, pancreas, spleen and major vascular structures. Long-term issues may include parasitic growth of retained tissue with the potential to cause adhesions, cause bowel dysfunction and potentially disseminate unrecognized cancer.
Safety concerns of morcellation devices in gynecologic surgery[edit]
Morcellation is associated with spreading of cellular material of the morcellated tissue. In gynecologic surgery for benign pathologies there is approximately a 0.09% risk of an unexpected leiomyosarcoma. After morcellation 64% of such cases may develop disseminated disease which is of particular concern because of the considerable mortality of leiomyosarcoma. Morcellation of the more frequent benign leiomyoma variants may also cause disseminated disease, which while not associated with increased mortality is frequently inoperable and therefore more difficult to manage than the original disease.[3][4]
On April 17, 2014 the Food and Drug Administration issued a warning that morcellators may spread occult cancer in the course of fibroid removal.[5] Johnson & Johnson subsequently suspended sale of its morcellators until the role of morcellation "is redefined by the FDA and the medical community."[5]
See also[edit]
                Instruments used in general surgery
References[edit]
1.             ^ Jump up to: 
a b c Disposable laparoscopic morcellator, GM Savage, JJ Christian, DC Dillow - US Patent 6,039,748, 2000
2.             ^ Jump up to: 
a b Morcellator, Jude S. Sauer, Roger J. Greenwald, Mark A. Bovard, John F. Hammond - US Patent 5562694. Issue date: Oct 8, 1996.
3.             Jump up 
^ Seidman, M. A.; Oduyebo, T.; Muto, M. G.; Crum, C. P.; Nucci, M. R.; Quade, B. J. (2012). "Peritoneal Dissemination Complicating Morcellation of Uterine Mesenchymal Neoplasms". In Sullivan, David J. PLoS ONE 7 (11): e50058. doi:10.1371/journal.pone.0050058. PMC 3506532. PMID 23189178. edit
4.             Jump up 
^ Cucinella, G.; Granese, R.; Calagna, G.; Somigliana, E.; Perino, A. (2011). "Parasitic myomas after laparoscopic surgery: An emerging complication in the use of morcellator? Description of four cases". Fertility and Sterility 96 (2): e90–e96. doi:10.1016/j.fertnstert.2011.05.095. PMID 21719004. edit

^ Jump up to: 
a b Robert Lowes (April 30, 2014). "J&J Suspends Power Morcellator Sales Over Cancer Risk". Medscape. Retrieved April 30, 2014.

Wednesday, June 18, 2014

U.S. near last in healthcare quality and affordability

In a new international ranking, the United Kingdom ranks first, while the U.S. performs poorly across almost all health metrics.
JUN 16 2014, 10:54 AM ET  FiDA Highlight
 The origin of the phrase "You get what you pay for" is sometimes attributed to the fashion mogul Aldo Gucci, who said, "The bitterness of low quality is remembered long after the sweetness of low price has faded." But when it comes to healthcare, Americans get neither quality nor affordability.
The United States healthcare system is the most expensive in the world, but when it comes to health outcomes, it performs worse than 11 other similar industrialized nations, according to a new report released today by the Commonwealth Fund.
The nonprofit examined the health systems of Australia, Canada, France, Germany, the Netherlands, New Zealand, Norway, Sweden, Switzerland, and the United Kingdom, and it found that the U.S. was last or near-last in measures of health access, efficiency, and equity.

Commonwealth Fund
According to the report, the United Kingdom, which has a single-payer healthcare system, ranks first. In second place is Switzerland, which like the U.S. has a compulsory health insurance system—though Swiss health insurers are not allowed to make a profit off their basic insurance plans.
It's important to note that one reason for America's lag, as the authors explain, is our historic absence of universal health coverage. But the data for the report was collected before the full implementation of Obamacare, which dramatically expanded health insurance, so it's possible that the U.S. may rise in future rankings.
And notably, both the U.K. and U.S. ranked low on the "Healthy lives" scale, which considers infant mortality, healthy life expectancy at age 60, and mortality from preventable conditions, such as high blood pressure.
The U.S. spends 17.7 percent of GDP on healthcare, much more than all of the other countries, while Australia spends the least—8.9 percent:

Commonwealth Fund
The metric the U.S. performed best on was "effective care." Particularly laudable were our preventative care efforts, which included things like physicians asking patients to eat healthy and exercise, and doctors' offices sending patients appointment reminders.
The U.S. fared poorly, meanwhile, when it came to managing administrative hassles for both doctors and patients, avoiding emergency room use, and reducing duplicative medical testing, all part of the score for "efficient care." 
"It is apparent that many primary care physicians struggle to receive relevant clinical information from specialists and hospitals, complicating efforts to provide seamless, coordinated care," the report authors note.
Americans also had the worst equity of care between high-income and low-income patients.
"The U.S. health care system is not the 'fairest of them all,'" the authors write, "At least from the viewpoint of those who use it to stay healthy, get better, or manage their chronic illnesses, or who are vulnerable because of low income and poor health."

The bitterness of that is likely to be around for a while, too.