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

Friday, February 27, 2015

Patient's sin is to rely on surgeon's advice! Surgical mesh trial.

BY COURTENAY EDELHART The Bakersfield Californian  Thursday, Feb 26 2015 05:47 PM  FiDA highlight
A jury of three women and nine men began deliberating late Thursday in a transvaginal mesh trial brought by a Bakersfield woman and her husband, a case that has garnered national attention.
Coleen Perry, 52, of Bakersfield, filed a lawsuit against New Brunswick, N.J.-based Johnson & Johnson and its wholly owned subsidiary, Ethicon Inc., over complications from a medical device implanted in her in March 2011 to treat stress-induced incontinence, or brief urination with coughing, sneezing, laughter or other exertion.

There has been a tidal wave of lawsuits over synthetic surgical meshes implanted through the vagina since the U.S. Food and Drug Administration issued a notification in 2008 that it had received high numbers of complaints about them. Three years later the FDA issued an advisory about serious complications.
In 2012, a jury awarded Christine Scott, also of Bakersfield, $3.6 million in a similar case against C.R. Bard Inc., which manufactures a rival device designed to treat the same condition.
Both women said after the implants, their incontinence did not improve, and they were left with chronic pain that had ruined their ability to have comfortable intercourse.
Perry is seeking at least $17.2 million for past and future medical expenses, pain and suffering and punitive damages.
Perry testified that her husband's penis has been left with abrasions by portions of the mesh that poked through her vaginal wall. She's had a follow-up surgery to remove the part that was sticking out, but the entire mesh cannot be removed because it is permanently intertwined with natural tissue.
Her attorneys argued that Johnson & Johnson knew it had a defective product and concealed those defects from doctors, consumers and the FDA, pointing to internal memos and emails in which employees cited concerns that went unheeded.
Johnson & Johnson said those emails had been "cherry picked" and produced other emails in which those same employees said they were reassured by testing.
Attorney William Gage asked jurors not to read too much into the exchange, saying it was a normal part of the development process.
"If your medical device company is not vigorously debating the safety of a medical device, we've got a real problem," he said.
Gage also said it was a coincidence that language describing the mesh as light weight was removed from a company website during the trial, putting a witness on the stand who said the website overhaul had been planned months ago and the timing was coincidental.
Over the course of the eight-week trial in Kern County Superior Court, Perry's lawyers argued that the company's laser-cut mesh was sharper and heavier than others on the market and therefore more prone to erosion and shrinkage.
Gage said no medical device is entirely without risk and Perry signed an informed consent form acknowledging a risk of erosion, among other things, prior to surgery. Moreover, he argued, she had a host of other medical conditions and procedures that likely were the source of her symptoms.
Perry's attorneys called that a red herring and put Dr. Hung Luu, who did the original surgery on Perry, on the stand. Luu started out as a defendant but was later removed as a party to the case, and testified that he would not have implanted the device had he known it was heavy (which Johnson and Johnson disputes) and had a lot of problems. Luu said he is no longer using the mesh in his practice.
The informed consent Perry signed wasn't actually informed, attorney Rich Freese argued, because all the facts weren't available to Perry or her doctor when Perry agreed to the surgery.

"Coleen relied on her doctor, and Dr. Luu was relying on Johnson & Johnson and Ethicon," he said. "That was Coleen's sin."

Friday, February 20, 2015

Bayer Essure 'birth control' Harm is in the news! Sign petition, please

By Mary Rezac  (FiDA highlight)

Denver, Colo., Feb 20, 2015 / 04:02 am (CNA/EWTN News).- Perforated organs, metal coils lodged in colons, fetal disfigurement due to nickel poisoning. Chronic pain, exhaustion, bouts of depression and suicidal thoughts.

It’s the stuff nightmares are made of. But these are real symptoms that are being blamed on a real medical device, one that is being protected by the FDA. The device, Essure, is a permanent type of birth control in the form of tiny metal coils inserted into women’s fallopian tubes.

But while it’s been on the market since 2002 and has been touted as safe and effective, thousands of people are starting to come forward and question the device, including doctors very familiar with it.

It started out as a standard procedure for Dr. Shawn Tassone, Ob/Gyn. He was inserting Essure coils into a patient. The 10 minute, in-office procedure was supposed to be quick, simple and painless, and it was one he had performed many times before.

“I remember…I put the Essure in, exactly like how you were supposed to, and then as I sat there the tube started to spasm, and it pulled the Essure in,” he told CNA. “It disappeared, it coiled right into the tube.”  

Unsure of how to proceed, he looked at the product manufacturer’s representative, who was in the room with him. The representative told him to just put another coil in the same tube, but Dr. Tassone knew that was against the product’s instructions.  

“I told (the representative) that, and he was like, 'Nah, that’s not necessarily true',” Dr. Tassone said. “And you’re just being told this stuff by these reps who are college graduates, and I’m sure their hearts are in the right place, but they also want you to do the procedure because they get reimbursed more.”

It was through personal experiences with patients, as well as hearing other women’s stories, that Dr. Tassone eventually stopped doing a procedure he’d once been so sure was safe and effective. He said that while he’s not a conspiracy theorist, he does believe there are a large number of women with severe complications from Essure that are not being acknowledged by the medical community at large.

A Facebook group 14,000 strong

A lot of these women can be found on the Facebook group, Essure Problems. Of the 14,000-plus members, the majority are women who share a strange kind of sisterly bond – almost all of them have had Essure, and almost all of them bitterly regret it.  

When the Essure coils are implanted, they are supposed to stay in the fallopian tubes, where they create a chronic infection that will cause scar tissue to form around the coils, effectively closing the tubes and rendering the woman sterile. The device was first manufactured by the group Conceptus and pre-approved by the FDA before hitting the markets in 2002. In June 2014, Conceptus was bought by Bayer, which has continued to manufacture and distribute Essure.

Some possible side effects after the Essure insertion procedure are listed on the product’s website and include: “mild to moderate pain and/or cramping, vaginal bleeding, and pelvic or back discomfort for a few days. Some women experienced nausea and/or vomiting or fainting. In rare instances, an Essure insert may be expelled from the body.”

Angela Desa-Lynch, an administrator for the Essure Problems group, said the women in the group have experienced these problems to the extreme.

“Whatever they’ve put on the label, multiply it by 200,” she said. “They say chronic pain, or they say mild cramping or abdomen pain, but they don’t tell you that it’s debilitating. They don’t tell you that it’s 'I can’t get out of bed and take care of my kids' kind of pain.”

When Desa-Lynch had her Essure coils in, she said she felt like she had the flu constantly. She was 28 years old, and her youngest son was just three months old.

“My little son…he had no idea the real parent I could be, because I was going through all these health problems,” she said. Desa-Lynch had to have a total hysterectomy to remove the coils, but she said the recovery process didn’t end with the removal.  

“You’re mad,” she said. “This is not what I signed up for. I just wanted a birth control, I didn’t want a life time of health issues, and to remove my woman parts, that’s not ok.”

Watching the posts on the page can be an emotional rollercoaster, Desa-Lynch said. She hears from women who’ve become depressed, suicidal, divorced, bankrupt, or a combination of those things after having complications from Essure.

Moving coils and the difficulty of removal

One of the most horrific complications is device migration, where the coil leaves the tube and becomes lodged in other parts of the body, usually the colon or somewhere in the pelvis. This can cause a blocked colon or other complications.

It can be extremely difficult for women who want to have their Essure coils removed. Many doctors will deny that the Essure is the root of women’s problems, because the clinical trials they’ve seen from the FDA claim the risks of such complications are so low.

Additionally, Medicare and most insurance companies classify Essure removal as “cosmetic,” which further disincentivizes doctors to remove the coils and often puts women who require the removal into personal debt.

“One woman had a coil in her colon, she went from a business owner to bankruptcy” after four surgeries to remove it, Desa-Lynch said.

Physical removal of the coils can also be difficult because they are fragile and may break.

“You have fragments now in your body, and we’ve had women where they come back after removal and they have these masses growing in their abdomen,” Desa-Lynch said. “Your body’s going to try to encapsulate whatever foreign object is there, and now you have all these little cysts growing everywhere.”

Both she and Dr. Tassone said that from what they’ve seen, the only completely safe and secure way to make sure all of Essure is removed is a total hysterectomy.

What happens if you get pregnant with Essure?

Then there are the women who become pregnant while using Essure. No sterilization method is guaranteed to work 100 percent of the time, save for a total hysterectomy with removal of the fallopian tubes. According to Essure’s website, the device is 99 percent effective at preventing pregnancy, but that is with so-called perfect use.

In the real world, doctors may misplace coils or a woman’s tubes can heal or push Essure out. Furthermore, women given Essure are told to use an alternative form of contraception for the first three months following the procedure until a second appointment which checks for proper coil placement – but many women fail to follow through on this step.

Given these margins for error, a recent Yale School of Medicine study estimated 96 of every 1,000 women who undergo hysteroscopic sterilization, or Essure, would get pregnant within 10 years. For laparoscopic tubal ligations (known as 'having your tubes tied'), the pregnancy risks were significantly lower: 24 to 30 pregnancies per 1,000 women.

In an e-mail interview, FDA representative Eric Pahon told CNA that clinical trials of women who became pregnant with Essure showed “no increased risk of neonatal or pregnancy complications, as long as the pregnancy is in the uterus. The FDA will continue to monitor the safety of Essure to make certain.”

What the women of Essure Problems have found is that doctors will not remove the coils even if a woman becomes pregnant. Most will automatically recommend abortion, because they don’t know what to do.

“They don’t know what can happen, because there is nickel in Essure and it can leach, and the device can move and perforate the sack and has done it, so because the doctors don’t know how to treat you, that’s the first thing they ask you to do is to terminate,” Desa-Lynch said.

Should a woman with Essure choose to continue the pregnancy – and many of them do – she risks nickel poisoning and device migration to her baby, and a 55 percent chance of miscarriage, according to the numbers from the Facebook group.

“Your baby isn’t growing”

One Essure pregnancy story stood out to Desa-Lynch as particularly jarring. A young woman in the Facebook group, born and raised as a devout Catholic, became pregnant despite being on Essure. At 24 weeks of pregnancy, the doctors told her: “Your baby is not growing.”

Her baby had gotten nickel poisoning, so the brain wasn’t developing and the limbs weren’t growing properly. The young woman was told her baby at best would be severely deformed at birth, if not completely brain dead.

“When you’re Catholic, abortion is not something that crosses your mind, you just think 'ok, well, we’ll deal with this',” Desa-Lynch said.

However, after the grim diagnosis, the young woman chose abortion. Desa-Lynch said the woman doesn’t even comment on the Facebook page because she is so haunted by her experience, but she’s there, and she watches the comments.

“I can’t imagine being in her position,” Desa-Lynch said. “It puts you in a hard spot. Here you think you’re doing what’s right for you, what’s right for your family, and what’s right for your health, and now you’re facing these situations that you don’t even know how to handle and neither does your doctor, and you have to go against all of your morals and values…I don’t know what I would do.”

“It goes against a lot of women’s morals,” she added, “and women get severely depressed. Someone posted just yesterday that one of her good friend’s daughters had (Essure) put in and she killed herself, because they go to a doctor and they don’t listen to you.”

When the suicidal posts started popping up more frequently, the group administrators decided to set up a buddy system of sorts. They connected women in the group with other women who were close by, so that they’d always have someone they could go to who understood their situation. The administrators watch posts closely and alert the smaller state groups of concerning posts.

“We work collectively and united,” Desa-Lynch said. “It’s amazing to see women pull together the way that they have and fight for each other.”

False data and bad numbers

As a medical device, Essure had a questionable start at best. When it was pre-approved by the FDA in 2002, the FDA used clinical trials from the device manufacturer, the company which would profit from the approval and sales of the device, to determine whether or not it was safe for women.

When asked if this process created a conflict of interest, the FDA responded: “Although the manufacturer may submit any form of evidence to the FDA in an attempt to substantiate the safety and effectiveness of a device, the FDA relies upon only valid scientific evidence to determine whether there is reasonable assurance that the device is safe and effective.”

Desa-Lynch and the administrators of Essure Problems have three full sets of records from the clinical trials that show complaints of abdomen pain in women in the trial being marked off as “unrelated.”

Dr. Tassone has seen the clinical trials, and said there are times when the ages of women with complaints or complications are crossed off and altered in order to better fit the picture the manufacturer wanted to portray.

“The clinical trials that they were basing their information on were falsified, and we’ve brought this to the FDA,” Desa-Lynch said. “They (the FDA) just say, 'upon their investigation they find everything to be safe, they find the benefits to outweigh the risks'.”

In addition, it is basically impossible to track exactly what percentage of women with Essure have experienced severe complications. Although Bayer and the FDA know that 750,000 kits have been sold, there’s no one keeping track of how many women have had the procedure.

Further complicating the numbers is the fact that multiple kits can be used for a single procedure. Dr. Tassone said he’s used up to three kits on a single woman, which happens if coils break before or during insertion.  

“We have over 200 women who’ve had two kits used on them,” said Desa-Lynch of the Essure Problems group, “So it’s kind of hard to give a percentage on bad numbers.”

Protected status and incentives

But despite the thousands of complaints, Essure is classified as a Class III medical device, a category reserved for devices with PMA (premarket approval). These devices are pre-empted, which means people injured by the product cannot collect damages from the manufacturer.

Typically, Class III medical devices are live-saving devices such as heart stints. The idea behind preemption is that by protecting companies from having to pay damages, it encourages them to continue creating better devices that are necessary for saving and sustaining lives.

The only Class III, protected medical devices that do not save or sustain life? Essure coils and breast implants.

“This is part of the problem,” Dr. Tassone explained. “When you are having studies being done by companies who are falling apart (Conceptus was bought out by Bayer), you have an inherent bias. If the (product) is revoked, then this multi-million dollar project was flawed somehow and they lose money.”

“And you see that with other devices, there is a lot of money involved, and the FDA is not doing due diligence, because sometimes the FDA has people on it who are not necessarily getting paid, but who are affiliated with some of the big companies.”

Doctors, too, receive incentives for using Essure. If they meet a certain implantation quota, the manufacturer gives them a $20,000 scope that can be used to perform multiple procedures. Doctors also are often paid to attend Essure trainings and conferences.

But Dr. Tassone said he believes that most doctors originally implanted Essure because they were told, and truly believed, it was a safe and effective procedure.

“We were told in the beginning that it doesn’t cause any pain and the initial studies that came out said that,” he said. “It makes it look like the doctors are getting greedy by putting Essure in because we get more money, but in reality, 99 percent of us actually believed it was a good procedure and was safer for the patients and it worked.”

He said the procedure itself is still considered less risky than a tubal ligation, which is an involved surgery rather than an in-office procedure. Still, Dr. Tassone stopped implanting Essure about a year and a half ago, and he said it usually doesn’t take much to convince his patients to opt for a different procedure.

“The way I counsel my patients now, I send them to what the Facebook group says,” he explained. “Usually I tell them Essure is a foreign body and it’s permanent - most women don’t want that, when you explain it that way.”  

Lawsuits and Erin Brockovich

There are only a few pending lawsuits involving Essure at the moment, Desa-Lynch said, because the PMA act goes all the way up to Congress.

But the Essure Problems Facebook group intends to fight until Essure is off the market and the PMA act is changed. And they just might win, because of a certain famous lawyer that has joined their fight.

“It kind of started as a joke on the form, like, 'Let’s e-mail Erin Brockovich, haha',” Desa-Lynch said. But they did, “and she listened!”

The lawyer, made famous from a 2000 film about her life as a single mother and environmental lawyer, has created a website,, where women who’ve had Essure can share their stories and where she posts the latest news about the fight against the device.

“That right there kicked off the empowerment, that kicked off the movement of 'Ok, we can do this',” Desa-Lynch said.

Dr. Tassone said he’d like to see more acknowledgement from the medical community of the pain and suffering Essure is causing some women, as well as more transparency from the manufacturers.

“Acknowledgement is the first step,” he said. “Like the company saying, 'Yeah, this is a foreign body and okay, let’s take a look at this.' That would go a million miles for some of these people, that maybe, it’s not all just in their head.”

He also wonders whether a device that caused similar reactions in men would even be on the market.

“If you have a coil and you said you were going to use it in men for vasectomies and you were going to insert it in to block the testicle from having sperm come out, would we be doing that or not? Because they could feel that implant,” he said.

“But with tubes, and in women’s health – because everything is on the inside - I think it’s out of sight, out of mind.”

Until the Essure Problems group can get their case pushed through in court, Desa-Lynch said it’s enough for them to keep informing women and to prevent them from getting Essure.

“We’ve saved over 600!” Desa-Lynch said proudly. “We keep track of them. That right there is enough to know that this is the right thing to do.

Again:  the petition to sign is here

Thursday, February 19, 2015

Social Media and Patient Activists: Read this!

Created 02/18/2015 - 17:36
Posted in Regulatory and Compliance [1] by MDDI Staff on February 18, 2015

Regulatory and Compliance
The most common pathway to market for medical devices is coming under fire from a social media campaign led by activists determined to get FDA to ban power morcellators used in hysterectomy procedures. 
Jim Dickinson

The main portal for admission of new medical devices to the market, Section 510(k) of the Food, Drug, and Cosmetic Act, is under attack again, this time from an unlikely quarter: an unconventional and social media-driven campaign led by Philadelphia cardiothoracic surgeon Hooman Noorchashm and his wife, anesthesiologist Amy Reed.
In February, the Philadelphia Inquirer published an article by Noorchashm in its Sunday health section headlined “A modern-day wolf in sheep’s clothing: FDA’s Center for Devices and Radiological Health (CDRH) [3]”—just the latest salvo in the couple’s 18-month multimedia efforts to ban power morcellation devices used to perform hysterectomy procedures. The article opened a new front in the couple’s fight: to repeal or radically alter Section 510(k).
Their campaign began after Reed’s hysterectomy with a Karl Storz power morcellator spread cancer throughout her abdomen, joining a general one-in-350 incidence rate in power morcellation, according to FDA.
Their efforts have been remarkably successful so far, attracting congressional as well as media support and culminating last November in an uncommonly rapid FDA “immediately in effect guidance [4]” urging manufacturer adoption of a boxed warning and two label contraindications. FDA guidances by definition are nonbinding, however.
Even this small step was swiftly denounced by the American Association of Gynecologic Laparoscopists, which has renamed itself simply AAGL, at its annual meeting in Vancouver, where it declared power morcellation “an effective, lifesaving tool in gynecologic surgery when used appropriately” that “should not be abandoned despite recent concerns about the dissemination of occult cancers.”
FDA’s modest, voluntarism-based action wasn’t enough for Noorchashm and Reed, whose campaign for an outright ban so far has attracted more than 87,000 signatures on a cyber petition [5] to end the devices’ use in all gynecological procedures.
They also want Section 510(k) itself repealed or amended to include a proof-of-safety requirement and a rigorous postmarketing surveillance requirement.
In February, their local Congressman, Republican Mike Fitzpatrick, was preparing a bill to do just that, according to Noorchashm (at press time, Fitzpatrick’s office had not responded to my request for confirmation).
FDA’s implementation of 510(k) has plenty of deficiencies. Five years ago, there was the memorable tumult over the collagen scaffold which, after two years of controversy and corrupt CDRH review allegations, the agency was forced to admit should never have been cleared for marketing [6].
As in the power morcellator case, a key and recurring theme is 510(k)’s gaping loophole on what “substantially equivalent” really means. Both devices were only vaguely similar to their predicates, and predicate-creep over years and even decades without any second look at safety documentation for new-technology products is a disconnect that should be obvious.
Not if there’s market millions to be made in that disconnect, and in user-fee funds (currently $5018 per submission) to be garnered at FDA. This combination understandably brings with it a certain degree of elasticity in “substantial equivalence” determinations by a CDRH that has come to regard product sponsors as “customers.”
When further combined with industry campaign support for candidates of both parties, this fiscal interdependency arguably enabled both Congress and FDA to ignore or dismiss a recommendation in the 2011 Institute of Medicine [7] report on 510(k) that the agency’s 510(k) program be scrapped.
In its place, the report said, should be a new regulatory framework for Class II devices that is not based on “substantial equivalence” but rather on an “integrated premarket and postmarket regulatory framework that effectively provides a reasonable assurance of safety and effectiveness throughout the device life cycle.”
The collagen scaffold and power morcellator controversies haven’t been the only storms to rock FDA’s 510(k) boat, and they likely won’t be the last. The IoM report cited safety issues with an artificial hip, surgical mesh, and medical-tubing connectors, among others.
In Noorchashm’s opinion, and that of former FDA medical device compliance director and noted device attorney Larry R. Pilot—a fierce defender of 510(k) which he helped write—a major issue is the quality of CDRH’s management, processes, and culture.
Noorchashm and other critics fault the center for “being in bed” with industry, while Pilot and others fault it for “incompetence” and failure to use the tools available to it to resolve problems.
These are legitimate issues, but they’re unlikely to be easily eliminated because they are deeply rooted in the very nature of government, across the board, in the American political system. Stakeholders have to be heeded, and the more money they have, the more they have to be heeded.
This is a dynamic that may be about to undergo radical change—something that Noorchashm and others representing injured patients are counting on.
Social media have given them potent tools they never had before. People-power is evolving as a key factor in government decisionmaking. FDA’s timid action on power morcellators came as swiftly as it did largely because of the effectiveness of Noorchashm’s skillful, even adroit multi-media efforts, especially after the Wall Street Journal [8] promoted them. He also credits FDA associate commissioner for policy and planning Peter G. Lurie [9]’s active cooperation.
Social media are changing everything. As mainstream media struggle to adjust, print yields to digital, and Twitter and Facebook replace the evening news, health activists representing injured patients and their families will eventually truncate FDA’s fossilized internal processes, gain seats at the table, and counter the heavy, hidden hand of the influence peddlers.
It’s coming faster than you might think. President Barack Obama’s widely reported initiative on precision medicine [10] actually would enlist “a million or more Americans to volunteer to contribute their health data to improve health outcomes, fuel the development of new treatments, and catalyze a new era of data-based and more precise medical treatment.”
The million or more may be expected to become much more interested, if not activists, in patient care technologies and their governance.
The precision medicine initiative aims to recruit collaborative public and private efforts to “leverage advances in genomics, emerging methods for managing and analyzing large data sets while protecting privacy, and health information technology to accelerate biomedical discoveries.”
Whether or not a Republican-controlled Congress goes along with this initiative—and there are signs that it might—FDA and industry’s old ways of doing things in Washington, DC, and at grassroots are already undergoing seismic change.
A grassroots challenge to 510(k) could be just a beginning. For those with long memories, it was a gynecological device, the Dalkon Shield IUD, and injured patient activism that fueled much of the legal and public agitation that led to the 1976 Medical Device Amendments and the enactment of Section 510(k).
The new patient-powered insurgency could be at least that effective, this time around.

Jim Dickinson is MD+DI's contributing editor.