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.
Please share what you have learned!
Twitter: @JjrkCh

Saturday, May 13, 2017

J&J Accused of Criminal Behavior: Pelvic Surgical Mesh

Women Allegedly Harmed by Pelvic Mesh Express Disappointment with J&J
ARTICLE | MAY 11, 2017 - 9:48PM | BY DAVE SCHATZ   FiDA highlight


MAM co-founder Lisa Mason is seen here during a rally on April 27 outside the State Theatre. Mesh Awareness Movement
NEW BRUNSWICK, NJ–Members of  the Mesh Awareness Movement (MAM) want Johnson & Johnson’s (J&J’s) shareholders “to know they are investing in criminal behavior,” according to a statement.
The group, a grassroots effort to bring awareness to the harmful effects of mesh on the human body, held a rally against J&J in New Brunswick on April 27, during its annual meeting of shareholders. 
MAM has a Facebook group that's grown from about 20 to 700 people in just a year-and-a-half, according to co-founder Tammy Jackson, who said others have contacted her but aren't keen on taking part in social media due to their attorneys' advice.
Jackson said a couple woman in the group were recently offered $189 by the pharma giant to settle their cases, but declined, while five others she knows personally accepted $4,000, and seven received $200,000, in the past six to seven months.
“It’s hard to get people so badly injured to travel across the country and stand all day,” said Jackson, a 50-year-old resident of Kentucky, and former nurse, adding she also brought chairs to the rally for some of the women.
Yet during the hour-plus meeting of shareholders inside the State Theatre, where audio was streamed live on the internet, the women held a protest outside the theatre and say they feel their voices were heard.
Their chants included:
  • “No more mesh…”
  • “Stop the harm, No more profits.”
  • “You are not going to be able to hide from us.”
  • “Profit over lives.”
Jackson has had 17 mesh removal and reconstruction surgeries over the past four years, she said.
“Trying to remove mesh out of your pelvic is like removing rebar out of concrete," said Jackson. "Your bladder is angry."
J&J says "we are nothing more than a 'cost of doing business.' We say, we are a hundred thousand severely and permanently injured people who could just as easily be your wife, mother or sister," continues MAM’s statement.
"It doesn’t matter to [J&J] that they’ll have to spend, for example, $2.5 Billion in Litigation, Verdicts, Penalties and fines because they’ve already made $25.1 Billion,” added the statement.
Jackson’s 10-year-old daughter was interviewed for a documentary about patient safety while in the Garden State with her mother and father for the rally.
She told the producers, “I would say quit making mesh and help my mommy,” according to Jackson, who said many MAM members were also interviewed for the film. 
“Where's the media?” wondered one MAM member during the rally. “They need to tape this -- we should flood the TV stations.”
One journalist, Jane Akre, operates the Mesh Medical Device News Desk (MMDND), and was present for J&J's annual meeting of shareholders on the morning of April 27. 
She thought the presentation to J&J's stock holders was "rehearsed" and highlighted "the health of J&J's stock," as Alex Gorsky, J&J's chief executive officer, repeated the words "sustainable" or "people come first." 
Yet across the street, she writes, via an "orderly, heart-felt display," some 30 women and their families rallied.
But their signs indicated they didn't feel like they came first: “The Johnson & Johnson Credo: ‘Research must be carried on, innovative programs developed and mistakes paid for.' Pay the mesh injured for your mistake!”
“Mr. Alex Gorsky” was targeted by another sign that continued, “The highest form of ignorance is when you reject that which you know nothing about.”
A sign urged Gorsky to “Talk to the mesh injured,” while the message on another read: “#SerialKiller CEO. It’s time for you to go!”
"Each [woman] represents at least 10,000 [pelvic] mesh implanted women who can’t make it to a mesh rally, because they are too sick or broke from fighting to regain their health! And that doesn’t even begin to include the one million hernia mesh implants a year!” wrote Akre.
"All use polypropylene! Some day in the not so distant future, we may come to recognize that this cheap plastic is not an ideal, bio-compatible material for an implant, I believe."
"The legal facts have shown that [J&J] knew these mesh devices were unsafe, but they quickly put them on the market anyway... bypassing proper FDA approval, failing to conduct thorough testing and withholding serious risks and warnings,” continues MAM’s statement.
"Little did I know that [during the shareholders meeting], a Philadelphia jury was delivering the third verdict for a plaintiff in another mesh trial – $20 million, which included $17.5 million in punitive damages!"
http://newbrunswicktoday.com/article/protest-targets-jj-ceo-day-annual-shareholder-meeting#.WRTstHiim44.facebook
Akre wondered whether J&J might now be considering a "multi-billion dollar global settlement" and whether "fighting mesh-injured women in court" is worth it. 
The pharma giant is facing $34.5 million in punitive damages, plus other amounts awarded by juries in three separate mesh trials in Philadelphia state court, according to reports.
Akre noted that after half a decade of writing reports for MMDND, media coverage of mesh issues is gaining  some traction.
"Internationally, the media is less afraid to report of Pharmaceutical Giants," she writes citing front page stories in Scotland, Australia, New Zealand and the UK, for instance.
Though Akre provided coverage of the April 27 MAM rally, she said very few reporters were there.
“It was a powerful day," said one woman who took part in the event.
"J&J had a line of buses on the other side of the street to block the view of the rally. [The company] rented those buses with money they earned from harming us,” she added, saying that she felt like J&J owned New Brunswick.

J&J did not respond to a request for comment. 

http://newbrunswicktoday.com/article/protest-targets-jj-ceo-day-annual-shareholder-meeting#.WRTstHiim44.facebook

Friday, May 12, 2017

A Small Victory: But Justice Would Stop PREVENTABLE Harm

ZIMMER HIP IMPLANT LAWSUIT RESULTS IN $2M AWARD FOR FAULTY HIP REPLACEMENT

By Heba Elsherif   FiDA highlight
April 17, 2017
Two million dollars has been awarded to an Albuquerque man for a faulty Zimmer hip implant.
Plaintiff Brian M., a former University of New Mexico economist, received a metal hip replacement in 2010. Shortly following the surgery, however, Brian suffered from metallosis, the medical condition that involves the accumulation and deposition of metal debris specifically in the body’s soft tissue. Metallosis occurs when the metallic parts grate or abrade against one another in implant surgeries such as joint replacements.

Brian was 62 at the time of his surgery and suffered from extensive excruciating pain in his hip. He claims that the pain was limiting his enjoyment of his active life and that he had to, inevitably, cut his golf and tennis days short, according to the Zimmer hip implant lawsuit.
The U.S. District Judge Nan Nash said that, “Zimmer Inc., created a faulty device and should pay for past expenses, lost wages, and future medical expenses necessary to remove the dead flesh.”
The judge also contended Zimmer was responsible for causing the infection that further developed because of the hip replacement surgery.
Brian claims that before his surgery, there were already lawsuits being filed about the occurrences of metallosis from hip replacement surgeries. As a result, he had looked at a multitude of option beforehand with his surgeon, and concluded that such incidences with hip replacement surgeries had been resolved, the Zimmer hip implant lawsuit explains.
According to Brian, however, that problem with the device that had been inserted, stemmed from metal debris deriving from the femoral joint, and not the hip socket joint. That metal debris resulted in sending the toxic metal into his leg and drove the deterioration of his leg muscle.
After surgery was performed to remove the metal pieces from his leg, a third operation had to take place to remove the deteriorated muscle that had been killed by the infection.
Treatment for the infection was prescribed and he had to have intravenous antibiotics twice a day for several weeks. Per the Zimmer hip implant lawsuit, “the threat of that infection re-emerging remains for the rest of his life.” Judge Nash had taken this into account when allotting the plaintiff, the $2 million.
Personal injury attorneys throughout the nation celebrate the victory and say that the lawsuit is one of many more to come against Zimmer..
Brian is unable to play as many sports but he sustains his walking ability.
He states of his success that although he was not surprised that the Zimmer hip implant lawsuit developed the way it had, the award granted is a “pleasant end to an ugly ordeal.

https://topclassactions.com/lawsuit-settlements/lawsuit-news/611511-zimmer-hip-implant-lawsuit-results-in-2m-award-for-faulty-hip-replacement/

Wednesday, May 10, 2017

Levaquin, Cipro for bacterial infections may cause irreversible severe harm.



FiDA highlight
This information is an update to the FDA Drug Safety Communication: FDA advises restricting fluoroquinolone antibiotic use for certain uncomplicated infections; warns about disabling side effects that can occur together issued on May 12, 2016
[05-10-2017] As part of our ongoing review of fluoroquinolone antibiotics, FDA is informing the public that patient cases identified by the FDA and findings from published studies currently do not support reports that these medicines may result in detachment of the retina in the eyes, or bulges or tears in the aorta blood vessel called aortic aneurysm and aortic dissection. We will continue to assess safety issues with fluoroquinolones and will update the public if additional actions are needed.
Safety Announcement
[ 7-26-2016 ] The U.S. Food and Drug Administration (FDA) approved changes to the labels of fluoroquinolone antibacterial drugs for systemic use (i.e., taken by mouth or by injection). These medicines are associated with disabling and potentially permanent side effects of the tendons, muscles, joints, nerves, and central nervous system that can occur together in the same patient. As a result, we revised the Boxed Warning, FDA’s strongest warning, to address these serious safety issues. We also added a new warning and updated other parts of the drug label, including the patient Medication Guide.
We have determined that fluoroquinolones should be reserved for use in patients who have no other treatment options for acute bacterial sinusitis, (ABS), acute bacterial exacerbation of chronic bronchitis (ABECB), and uncomplicated urinary tract infections (UTI) because the risk of these serious side effects generally outweighs the benefits in these patients. For some serious bacterial infections the benefits of fluoroquinolones outweigh the risks, and it is appropriate for them to remain available as a therapeutic option.
Patients must contact your health care professional immediately if you experience any serious side effects while taking your fluoroquinolone medicine. Some signs and symptoms of serious side effects include unusual joint or tendon pain, muscle weakness, a “pins and needles” tingling or pricking sensation, numbness in the arms or legs, confusion, and hallucinations. Talk with your health care professional if you have any questions or concerns (see List of Serious Side Effects from Fluoroquinolones).
Health care professionals should not prescribe systemic fluoroquinolones to patients who have other treatment options for acute bacterial sinusitis (ABS), acute bacterial exacerbation of chronic bronchitis (ABECB), and uncomplicated urinary tract infections (UTI) because the risks outweigh the benefits in these patients. Stop fluoroquinolone treatment immediately if a patient reports serious side effects, and switch to a non-fluoroquinolone antibacterial drug to complete the patient’s treatment course (see List of Currently Available FDA-approved Fluoroquinolones for Systemic Use).
Fluoroquinolones are antibiotic medicines that work by killing or stopping the growth of bacteria that can cause illness. They are FDA-approved to prevent or treat certain serious bacterial infections.
The labels of fluoroquinolone medicines already have a Boxed Warning for tendinitis, tendon rupture, and worsening of myasthenia gravis. The labels also include warnings about the risks of peripheral neuropathy and central nervous system effects. Other serious risks associated with fluoroquinolones are described in the labels, such as cardiac, dermatologic, and hypersensitivity reactions. After FDA’s 2013 review that led to the additional warning that peripheral neuropathy may be irreversible, FDA evaluated post-marketing reports* of apparently healthy patients who experienced disabling and potentially permanent side effects involving two or more body systems after being treated with a systemic fluoroquinolone (see Data Summary). We evaluated only reports submitted to FDA, so there are likely additional cases of which we are unaware. The side effects occurred within hours to weeks after starting the fluoroquinolone, and at the time we received the reports, the side effects had continued for an average of 14 months to as long as 9 years after stopping the medicines. Several cases reported that some side effects stopped or improved after discontinuation of the medicine; others reported the side effects worsened or continued.
We previously communicated about these safety issues associated with fluoroquinolones in May 2016. Additional communications about related safety issues associated with fluoroquinolones occurred in August 2013 (peripheral neuropathy) and July 2008 (tendinitis and tendon rupture). The safety issues described in this Drug Safety Communication were also discussed at an FDA Advisory Committee meeting in November 2015.
In addition to updating information in the Boxed Warning, we are also including information about these safety issues in the Warnings and Precautions section of the label. The Indications and Usage section contains new limitation-of-use statements to reserve fluoroquinolones for patients who do not have other available treatment options for acute bacterial sinusitis (ABS), acute bacterial exacerbation of chronic bronchitis (ABECB), and uncomplicated urinary tract infections (UTI). The patient Medication Guide that is required to be given to the patient with each fluoroquinolone prescription describes the safety issues associated with these medicines. We are continuing to assess safety issues with fluoroquinolones as part of FDA’s usual ongoing review of drugs and will update the public if additional actions are needed.
We urge health care professionals and patients to report side effects involving fluoroquinolone antibacterials and other drugs to the FDA MedWatch program, using the information in the “Contact FDA” box at the bottom of the page.

*The cases were reported to the FDA Adverse Event Reporting System (FAERS).

Tuesday, May 9, 2017

No Objective Patient Outcome Data: Sacrificial Lambs




Updated: May 07, 2017 9:51 AM CDT

By Kent Luetzen

MISSOULA -
Women from around the country who have been harmed by medical devices such as Essure --  a type of birth control -- used their voices to rally on Saturday. One rally was held in Missoula in hopes of raising awareness about what they call "hidden dangers" of some FDA-approved products. 




The group says women deserve better communication from doctors on the side effects of products and for manufacturers to not hide behind the FDA's pre-market approval certification.
For some of these women, products which were said to be safe have caused serious health issues including autoimmune diseases such as eczema, lupus and celiac disease.
Ray Curtis, who’s wife died from hysterectomy complications, is hoping Montana legislators will continue their work to protect women.
"They're (treated) almost like human guinea pigs. These devices are being used for purposes they weren't intended to be used for," Curtis said.  "Legislation can bring about awareness to begin with, but also get government to protect woman who are unsuspected like my wife and me... we didn't know.."

Missoula's rally was just one of over 20 throughout the United States.

Sunday, May 7, 2017

Verdict $110M: Johnson & Johnson Baby Powder and Ovarian Cancer

  • 5 May 2017  FiDA highlight
Pharmaceutical firm Johnson & Johnson (J&J) has been ordered by a US court to pay more than $110m (£85m) to a woman who says she developed ovarian cancer after using its talcum powder.
Lois Slemp, 62, from Virginia, Missouri said she developed the cancer after four decades of using talc products.
Prosecutors argued the company did not adequately warn about the cancer risks associated with the items.
Experts say links with ovarian cancer are unproven. J&J says it will appeal.
The verdict in a St Louis state court is the largest so far to arise out of about 2,400 lawsuits against J&J over its talc-based products, Reuters news agency reports.
Ms Slemp is currently undergoing chemotherapy after her ovarian cancer initially diagnosed in 2012 returned and spread to her liver.
She said the products she used included J&J's Baby Powder and Shower to Shower Powder.
"Once again we've shown that these companies ignored the scientific evidence and continue to deny their responsibilities to the women of America," said Ted Meadows, a lawyer for Ms Slemp.

The verdict included $5.4m in compensatory damages and $105m in punitive damages against J&J.
The company said it planned to appeal. "We are preparing for additional trials this year and we continue to defend the safety of Johnson's Baby Powder," it said in a statement.
"We deeply sympathise with the women and families impacted by ovarian cancer."
J&J lost three jury verdicts last year in cases related to its talc-based products, but won its first trial in March, when a jury in Missouri sided with the company.
There have been concerns for years that using talcum powder, particularly on the genitals, may increase the risk of ovarian cancer.
But the evidence is not conclusive. The International Agency for Research on Cancer classifies talc used on the genitals as "possibly carcinogenic" because of the mixed evidence.
Why is there any debate?
The mineral talc in its natural form does contain asbestos and does cause cancer, however, asbestos-free talc has been used in baby powder and other cosmetics since the 1970s. But the studies on asbestos-free talc give contradictory results.
It has been linked to a cancer risk in some studies, but there are concerns that the research may be biased as they often rely on people remembering how much talc they used years ago. Other studies have argued there is no link at all and there is no link between talc in contraceptives such as diaphragms and condoms (which would be close to the ovaries) and cancer.
Also there does not seem to be a "dose-response" for talc, unlike with known carcinogens like tobacco where the more you smoke, the greater the risk of lung cancer.
What should women do?
The charity Ovacome says there is no definitive evidence and that the worst-case scenario is that using talc increases the risk of cancer by a third.

But it adds: "Ovarian cancer is a rare disease, and increasing a small risk by a third still gives a small risk. So even if talc does increase the risk slightly, very few women who use talc will ever get ovarian cancer."

Tuesday, May 2, 2017

Plastic Mesh Surgically Implanted in Mothers: What Could Go Wrong?



April 28, 2017  FiDA highlight

Kim Blieschke had no idea her life would change irreparably when she was advised to undergo a “straightforward” surgery to correct pelvic organ prolapse – a complication from childbirth that results in surrounding organs to bulge or sag down into the vagina.
But moments after waking up from her transvaginal mesh implant procedure in 2006, where a web of polypropylene plastic was embedded into her vaginal wall, the mum-of-four knew “something wasn’t quite right”.
“I was in intense pain that they couldn’t control,” Kim told me over the phone from her Port Pirie home, in the South Australian countryside.
“I woke up with quite substantial bruising all over my buttocks and perineum and upper thighs. The bruises were the size of my hand.”

"I had necrotic flesh in there." (Image supplied)
"It was a pain like you wouldn't believe," she said. "Doctors said I'd be in the hospital for two or three days, but I was there for seven. On the three-hour car ride home, sitting was almost unbearable."
From there, Kim's condition spiralled.
"My doctor kept saying it will be better, it will be better, but I ended up taking three months off work," she told me. "I couldn't drive, I couldn't lift, I couldn't even sweep the floor."
Doctors made Kim feel like she was imagining the pain, but as a seasoned paramedic, she knew something was awry when her vagina developed a "foul smell".
"I told my GP something wasn't quite right, and it turned out I had necrotic flesh in there."
The polypropylene - a material used to create everything from plastic chairs to water bottles - had ignited Kim's natural foreign body reaction. Her body wasn't just trying to fight the mesh, it was trying to kill it.

The Therapeutic Goods Administration says transvaginal meshes were approved by "conformity assessment certification either from a EU certification body or the TGA".
By 2014 the TGA admitted its assessment process for the mesh was not “mature” and lacked “rigour”, and subsequently announced there was “little evidence to support the overall effectiveness of these surgical meshes as a class of products”.
By 2015 - a decade after mesh was first approved for embedding within the vaginas of thousands of Australian women - 72 of the 100 mesh products on the Australian market were delisted.
Despite this, where the TGA acknowledged shortcomings of the devices, it mostly blamed "the skill and training of the surgeon and the patient selection".
While the TGA said in a statement to Channel 10 it has only received 205 adverse event reports, and "the reported rate of complications was low", Kim argues this is because the channels of reporting post-surgical problems is convoluted and lacks transparency.

The implant that Kim was told to not worry about, the one she was told was simple and straight forward, was eroding away, and destroying her body with it.
"I felt like I was rotting from the inside," she describes.
By the time 2013 rolled around - some seven years after Kim's surgery - her surgeon had retired. The South Australian mum had developed chronic nerve damage which consumed her right hip, knee and two of her toes.
The fetid mesh was deeply affecting her sex life with longterm partner Jared, too.
"When I had intimate relations with my partner, he could feel the hard and brittle arms of my implant against him. It was unbearable.
"A lot of women's partners and husbands have just walked away and left them because of the impact it has on their sex lives, but thankfully my partner has been wonderfully supportive."
The "disastrous" effect the mesh has had has seen Kim spend "hundreds of thousands of dollars", take months at a time off work, and use up all of her long service leave just to find some relief from the constant pain.
Because the real clincher is this: While Australian surgeons are more than happy to insert mesh into women's pelvic floors, they're not so willing to remove it. In fact, there are only two doctors in the world who offer to take out transvaginal mesh, and both live in the United States.
To have the toxic mesh removed requires a six-month stint off work to visit the US, and an upfront payment of $50,000, something Kim pursued and succeeded with.













There are only two doctors in the world who offer to take out transvaginal mesh. (Image supplied)
While the mesh might be out of her body, the havoc it wreaked is irreversible and will stay with Kim forever.
"My mesh was embedded in my bowel, my rectum, and my urethra," Kim told me. "Now, my whole pelvic floor is just a massive scar tissue. I am now incontinent, my nerve damage and muscle damage is permanent, and I live on medications."
Kim also lives with a level of anxiety she likens to post traumatic stress disorder.
"I'm certainly not the woman and I am not the mother I once was," she said. "I feel like I've lost a big part of myself. I can't be with my kids as much as I'd like, I can't play or do all the things I wanted to do with them. There are some days when I can't get out of bed."
If there is any solace in this tragedy, it's that Kim Blieschke can find comfort in the other Australian women who have also lived this hell. In fact, hundreds have reported serious health complications as a result of transvaginal mesh implants to the TGA, and a medical review predicts there are 4000 more silently suffering in the shadows behind them.
When Kim found someone who had experienced what she had online, she was overwhelmed.
"I just burst into tears because I honestly thought that I was on my own," she said. "I was told that it was all in my head, and to find that there was someone else, and for all these women to come forward was incredible.
"It's something that nobody really wants to talk about because people feel embarrassed, but as far as I'm concerned I want everyone to know about it."


"I want everyone to know about it." (Image supplied)
Kim is now one of the handful of women who are leading the charge to have transvaginal mesh implants banned. Her meeting with Victorian Senator Derryn Hinch last year proved pivotal in pushing discussion forward about what Hinch describes as "one of the greatest medical scandals and abuses of mothers in Australia's history".
It falls in line with the opinion of The Royal Australian and New Zealand College of Obstetricians and Gynaecologists, who state that "very little robust information is available on the efficacy and long term safety" of polypropylene mesh to treat pelvic organ prolapse, warning women of "adverse" effects.
Thanks to women like Kim, and Senator Hinch, there is now a Senate inquiry into the mesh, which has a reporting date of November 30.
But the aim is to do more than just have the mesh banned - it's to get justice.
"We would like someone to be answerable to this," Kim explained. "Because none of the surgeons are mandated to report the complications, they don't. We want women to have informed consent, because a lot of women are just told this is a straight forward operation when it's not, it can ruin lives."
And on behalf of Mamamia, we dearly hope Kim, and the many women beside her, succeed.
If you are a victim of transvaginal implants, Mamamia encourages you to lodge a complaint by clicking on your state: 


 http://www.mamamia.com.au/transvaginal-mesh-implants/