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.
Twitter: JjrkCh

Monday, May 2, 2016

Why Patients Don't Hear About Failed Medical Devices Until It Is Too Late . . .

Media mystery: Why did journalists ignore an important study on a costly, harmful back pain procedure?

April 20, 2016 (FiDA highlight)

Kevin Lomangino is the managing editor of He tweets as @KLomangino.

What qualifies as “news” in the topsy-turvy world of health care can be a real head-scratcher sometimes.
A few weeks ago, the New York Times reported in some depth about a two-week, 9-person study of bicyclists headlined, Chocolate Can Boost Your Workout. Really.
That kind of coverage is exasperating. Especially when you consider that last week, I could find no mainstream news coverage — nada, nothing — about a 10-year, award-winning study that, according to several knowledgeable experts, has tremendous clinical and financial implications for the treatment of back pain in the United States.
The study was titled, “Does provocative discography cause clinically important injury to the lumbar intervertebral disc? A 10-year matched cohort study.”
But that title apparently wasn’t provocative enough for journalists on the health care beat.
It’s a shame the researchers couldn’t find a way to work the word “chocolate” into their study.
High costs and potential for harm
Provocative discography” is a diagnostic procedure that’s used up to 70,000 times a year in the United States at great cost to the health care system. It’s commonly performed on patients with so-called “degenerative disc disease” who are considering spinal fusion surgery — a $40 billion per year industry in the U.S. In an attempt to pinpoint the disc that’s causing problems, the surgeon will typically do a pressurized injection of the suspect disc and one or two non-degenerated control discs.
Experts say that provocative discography has no proven benefit for identifying symptomatic discs and has previously been shown on magnetic resonance imaging to be associated with faster degeneration of injected discs. The new study followed 75 patients who received the injections and compared them to 75 matched controls. The point of the new study was to see whether the disc degeneration seen on MRI would translate into clinically important back pain symptoms.
There was no significant history of back pain in either group when the study began. But the new 10-year data showed that there were more back pain surgeries (16 vs. 4); more frequent sciatica and back pain syndromes, and greater work loss and doctor visits for low back pain in the punctured discs compared to controls.
More pain. More surgery. More costs.
All with a procedure that’s still performed tens of thousands of times a year.
But no news coverage.
An expert asks: “Why would providers perform this test?”
James Rickert, MD, an orthopedic surgeon and contributor to, called it a “very important study.” The study has limitations, Rickert noted, including the fact that 40 out of the 150 patients were lost to follow-up during the 10-year study period.
“But readers should be aware that a trial of this sort with 10 years of follow up is very compelling evidence of discography’s potential problems,” Rickert says. “Such long term studies are rare,” he adds, and this one should tell readers: “Do not go undergo provocative discography.”
Patients looking for relief are subjected to all sorts of tests but provocative discography is the most invasive, and, typically, causes some insult to structures that are either normal or are not pain generators for the patient.  Add in the low diagnostic yield for patients, why would providers perform this test?
Similarly, Steven Atlas, MD, MPH, another contributor, likened the issue to a “house of cards” that’s finally beginning to topple. He noted that responses to provocative discography depend upon a variety of factors including the physician’s technique for performing the procedure.
So, not surprisingly, results are not very reliable. We also know that patients who have fusion based upon findings of provocative discography don’t do any better than individuals who have surgery but don’t undergo this test. We also know that patients can report more pain after the procedure, including pain they didn’t have before the procedure. And now we know that there are long-term risks associated with discography.
Mark Schoene, editor of The Back Letter as well as a contributor, emphasized that the study also threatens companies developing new biologic treatments that might help fix degenerated discs.
Most of these companies are planning to deliver those therapies via disc injection. The compounds they will inject, however, often have large-size molecules and will require large-bore needles—as large or larger than the needles employed in [these] studies. This suggests that these therapies may actually cause harm through the acceleration of disc degeneration.
Schoene said that companies producing these therapies are fearful that the studies may prompt the FDA to alter its safety standards regarding these injections—and order long-term human safety studies. Human studies of these injections would take a decade or more to perform and “could stop this new business in its tracks,” he said.
Few vested interests pushing reduction of unnecessary care
The news media weren’t entirely silent on the issue of back pain last week. The Minneapolis Star Tribune had a hard-hitting exposé on Medtronic’s Infuse bone graft device. It asked why more than a thousand adverse events associated with the device weren’t reported to the FDA.
A handful of stories (HealthDay, WebMD) also reported on a pair of New England Journal of Medicine studies (see here and here) looking at clinical outcomes for spinal fusion surgery. They reported that the more invasive and costly fusion surgery isn’t any better than a simpler surgery known as decompression for patients with pain resulting from spinal arthritis.
But the silence about provocative discography is provocative. With such huge implications, how can this critical study have received no mainstream media coverage? (The study was, after all, the subject of a news release put out by the North American Spine Society that should’ve pinged journalists’ radars.)
Rickert says it mainly comes down to who’s willing and able to invest in publicity for these studies.

“When a clinical trial shows positive results for a test/procedure, the manufacturer deploys an army of salesmen and media specialists and publicists to publicize the data,” Rickert notes. “That doesn’t happen with studies that call existing procedures/tests into question.”

Sunday, May 1, 2016

Settlement Gag Clause: 'Instance of Misconduct' 2005

Bill Would End Gag Clauses That Stifle Victims Who Sue

April 19, 2005|Jordan Rau | Times Staff Writer

SACRAMENTO — Wendy Conner asked a San Diego doctor to smooth over a forehead scar in 2000. But her plastic surgeon injected fat from her abdomen into an artery in her head, permanently blinding her right eye.
Conner sued and eventually settled for what she says was a small sum. As part of that legal agreement, she promised not to turn the doctor in to state authorities. "It's a horrible thing when somebody does something so terrible to you, and then you have to cover for them for the rest of your life," she said.
For decades, negligent doctors and other professionals in California have deterred their victims from reporting them to state regulators by making silence a condition of settling lawsuits. Regulators, consumer advocates and lawmakers say these legally dubious gag clauses are among the most troublesome gaps in California's consumer protection efforts.
They are pressing to ban the stipulations, even though Gov. Arnold Schwarzenegger refused to do so last year. The governor vetoed legislation that had passed with bipartisan support, saying that eliminating gag clauses "does not further the goal of making California more business-friendly."

"The whole practice is just unconscionable, and it deprives executive branch agencies of the information they need to do their job," said Julianne D'Angelo Fellmeth, the state-appointed independent monitor for the Medical Board of California. "I don't understand how the governor didn't see that the first time around."
Conner still will not publicly identify her surgeon even though the medical board in January forced the doctor, Richard M. Escajeda, to surrender his license. Investigators charged that the year after he blinded Conner, Escajeda botched a breast implant surgery in another woman and then failed to anesthetize her properly during a subsequent surgery, causing her to experience the entire painful operation.
There are other reasons besides gag clauses that regulators never learn of lawsuits that could be evidence of professional malfeasance. Court officials and hospitals, for instance, are required by law to report criminal convictions, disciplinary actions and civil judgments against doctors, but Fellmeth's evaluation of the medical board last fall found that many do not.
The problems are not limited to the medical profession. Under state law, attorneys and automobile makers are banned from trying to stop former clients from complaining to regulators, but there are no similar prohibitions for 230 other types of licensed professionals in California.
Democratic lawmakers have resurrected last year's proposal as AB 446, sponsored by the chairwomen of the two legislative panels that oversee the state's professional regulators, Assemblywoman Gloria Negrete McCloud (D-Chino) and Sen. Liz Figueroa (D-Fremont). An Assembly hearing is set for today.
The measure would still allow secret settlements in which plaintiffs promise not to reveal the nature of the case's resolution, including the amount of money paid out. But 2.3 million California professionals -- including accountants, architects and embalmers, as well as healthcare professionals such as doctors, psychologists and nurses -- would face discipline from California's regulatory boards if they were to insert gag clauses that dissuaded plaintiffs from making complaints to authorities.
"Gag clauses in malpractice settlements present unnecessary roadblocks which impede the medical board's investigators from their sworn duty to protect the public," the board president, Mitchell Karlan, said through a spokeswoman. State regulatory boards for 10 other professions endorsed last year's effort to outlaw the provisos.
The strongest opposition has come from builders, engineers and small contractors. They fought last year's proposal and are preparing another campaign to block this year's version.
Richard Markuson, deputy executive director of Consulting Engineers and Land Surveyors of California, a Sacramento-based association, said professionals already are required to report to regulators any large civil lawsuit settlements.
"This would eliminate some of the finality that a settlement could bring to parties in a dispute," Markuson said.
Schwarzenegger agreed, writing in his veto message that "even after the resolution of a civil suit, this bill could still require a licensee to [undergo] a second adjudication before a regulatory body."

It is far from clear that the gag clauses are enforceable. The attorney general's office last year told lawmakers that it believed such clauses cannot be imposed, citing several judicial rulings.
One was a 2000 appeals court ruling that voided a settlement that prohibited customers of a securities agent from reporting misconduct. The court ruled that the inclusion of the confidentiality clause was "not only directly connected to [the agent's] misconduct, but is an instance of misconduct in itself."

Still, advocates and plaintiffs say the pressure to consent to gag clauses often is intense.

Saturday, April 30, 2016

Public Citizen sues FDA for information on Advisory Panel participants


Related Press Releases:

Advisory committees furnish expert advice to federal government agencies. The FDA has approximately 50 advisory committees and panels that the agency advice on issues related to FDA-regulated products, such as whether the FDA should approve new medical products, request additional studies, or change a product’s labeling. The FDA posts on its website a roster of the members serving on each advisory committee, frequently accompanied by members’ curricula vitae (CV). The FDA frequently redacts the CVs, however, by blacking out information about the dates of degrees conferred, the names of professional colleagues and mentors, the amounts of grants received from private companies, and the names of unpublished articles. Many of the redactions were unaccompanied by any indication of why, but many were marked to indicate that the FDA believed that the redacted information fell under the Freedom of Information Act (FOIA) exemptions for confidential commercial information and for material the disclosure of which would cause an unwarranted invasion of privacy.

CVs are compiled by individuals specifically for the purpose of sharing information about the individuals’ background. Believing that the redactions based on the FDA’s determination that the information is “confidential” or “private” are thus unjustified under FOIA, and that the information redacted would help the public better to assess the backgrounds, qualifications, and potential biases of advisory committee members, Public Citizen submitted a FOIA request to the FDA in May 2014, in which Public Citizen requested “unredacted” copies of the CVs. As of April 2016, only three of the FDA’s six divisions had responded to the request, and all but one continued to redact information from the CVs.

Public Citizen sued the FDA under FOIA seeking an order compelling the FDA to respond fully to its request, without the redactions that appear to be wholly unjustified. In addition, because FOIA requires agencies to post frequently requested records online and the FDA’s website concedes that advisory committee member CVs are frequently requested, the suit seeks an order requiring the FDA to post unredacted copies of the CVs on its website going forward.

Tuesday, April 19, 2016

Bayer Alters 'Essure' Adverse Event Reports

Fitzpatrick Questions FDA About Essure Reporting

April 19,2016 (FiDA highlight)

WASHINGTON, D.C. — Congressman Mike Fitzpatrick (PA-8) sent the following letter to the Food and Drug Administration Tuesday regarding dramatic changes in the reporting of adverse events caused by the medical device Essure:

Dear Dr. Shuren,
Information has been brought to my attention that shows a dramatic change in how Adverse Event Reports relating to the permanent sterilization device Essure were submitted to the FDA coinciding with the agency’s announcement that it was reviewing the safety of the device.

As you know, when a manufacturer submits an Adverse Event Report to the FDA one of the data fields to be filled is “Reporter Occupation.” Examples of how that field can be coded by the manufacturer include “Physician,” “Health Professional,” “Nurse,” “Pharmacist,” “Paramedic,” “Risk Manager,” and “Other.”
As it relates to Essure, from January 2002 through June 2015, the manufacturer of the device submitted nearly 600 Adverse Event Reports in which the “Reporter Occupation” field was coded as “Physician.” This corresponds to the narrative information included in the report in which it clearly states the information in the report came from a medical doctor, a Gynecologist/ Obstetrician, a physician, or other similar term.
However, this coding changed dramatically in July 2015. I find this extremely concerning given the fact that on July 17, 2015, the FDA announced it was reviewing the safety and effectiveness of the Essure device.
After the FDA’s public announcement, Adverse Event Reports received by the agency from the manufacturer of Essure no longer coded reports from medical doctors as Physician reports. Instead, almost every report received from a physician between August 2015 and February 2016 listed the Reporter Occupation field as “Other.” This is a clear change from how the manufacturer coded prior to FDA’s announcement despite the same keywords, like medical doctor or Ob/Gyn, being found in the narrative portion of the reports. A similar change was noted in reports received from nurses.
I respectfully request the FDA to review the Adverse Event Reports from physicians and provide answers the following questions:
1. Did the FDA request the manufacturer to change how it was coding physician reports?
2. If the FDA did not request this change, is there a legitimate basis by which a manufacturer would suddenly change how they code reports from medical doctors and Ob/Gyns and code the occupation as “Other” instead of as “Physician”?
3. Was the FDA aware of this change?
4. Did the manufacturer of Essure notify the FDA it was changing how it reported the Report Occupation field within the Adverse Event Reports?
5. Was the FDA aware of this change prior to the September 24, 2015 Advisory Committee meeting related to Essure?
6. Does the FDA review Adverse Event Reports with the Reporter Occupation field coded as “Physician” differently than reports coded as “Other?” Are “Physician” reports given more weight when FDA is reviewing Adverse Event Reports than reports coded as “Other?” If so, please describe the differences in how the FDA reviews a report received from a physician compared to other types of reports.
7. If the FDA were to generate a list of Adverse Event Reports received from “Physicians” about Essure, would reports coded as “Other” be included? If the Reporter Occupation is listed as “Other,” does the FDA conduct additional analysis of the narrative portion of the report to determine if the report came from a medical doctor?
8. Is it illegal for a manufacturer to knowingly manipulate data listed on an Adverse Event Report?
9. What are the penalties for knowingly submitting false information to the FDA in an Adverse Event Report?
10. Has the FDA ever held a manufacturer accountable for falsifying or intentionally miscoding information submitted in an Adverse Event Report?
I appreciate your prompt attention to this request. Should you have any questions, please do not hesitate to contact Justin Rusk on my staff.

Statement of Dr. Zuckerman on Bayer’s adverse reports on Essure

Statement of Dr. Diana Zuckerman, President
National Center for Health Research

Bayer’s vague labeling system of Essure contraceptive problems brought to Congress’s attention
April 19, 2016
This seems to be a clear attempt by Bayer to make the adverse reports regarding Essure seem less credible. By counting physicians and other health professionals as “other,” Bayer assumed correctly that the FDA would take them less seriously. And, the same thing would happen when the FDA reported those adverse events.

This is not the first time that Bayer has misrepresented information about the risks of Essure, and it is time for the FDA to realize that they can’t trust the information that the company is providing.

Wednesday, April 13, 2016

AU "living nightmare" with J&J Prolift pelvic mesh!

April 13, 2016 - 8:15PM

Joanne McCarthy (FiDA highlights)


Five years ago Gai Thompson warned Australia's peak health bodies of a looming disaster involving women receiving mesh device implants to treat common problems after pregnancy, birth and hysterectomies.
This week Mrs Thompson and others are speaking publicly for the first time as they plan a rally in Canberra and call for a formal inquiry into the health regulators and medical bodies they say have failed them.
They are the women who, in many cases, can no longer have sex, have lost their jobs, have had to mortgage or sell their homes, have travelled overseas for surgery to remove the mesh, have suffered excruciating chronic pain, are resistant to some antibiotics because of chronic infections, and have suffered in isolation and silence – often for years.

"We've lost so much that I can't believe in this day and age this can happen to women, that our lives are being destroyed and no one cares," Mrs Thompson said.

In America tens of thousands of mesh victims have taken manufacturers and doctors to court and been awarded damages of up to $12.5 million. In Australia the response from women has been slower because of fewer numbers and isolation, but it is growing, says Australian Pelvic Mesh Support Group founder Caz Chisholm.
A planned rally by her group in Canberra in late May will target one of Australia's peak health regulators, the Therapeutic Goods Administration (TGA), which approved the first of more than 40 different mesh devices for transvaginal (through the vagina) surgery to treat prolapse in 2005. Prolapse is where pelvic muscles and ligaments are weakened after pregnancy, birth or hysterectomy.
The TGA approved the devices despite no evidence of their safe use in prolapse cases and clear warnings in 2003 of the need for controlled trials on related mesh devices.
Eleven years later, in a letter to a patient advocate in 2014, the TGA conceded its assessment process for mesh devices had not been "mature" and lacked "rigour". The letter coincided with belated TGA action requiring clinical evidence from manufacturers of the safety and efficacy of transvaginal mesh devices.
Mrs Thompson's life after mesh surgery in February, 2008, is reduced to a one-page incident report on the TGA website.
She is the woman whose adverse event report to the TGA in October, 2011 about the Johnson & Johnson Prolift mesh device, noted she could no longer have sex and her life after February, 2008 had become "a living nightmare".
The report noted multiple urinary tract infections leaving her resistant to some antibiotics, chronic and severe pelvic pain, chronic bowel problems, incontinence, multiple areas where the mesh had eroded into her vagina, and that she was unable to stand for any length of time, suffered constant fatigue and stress, and had needed successive surgeries and treatments.
She was unable to work and as a consequence she and her husband had been forced to sell their home, Mrs Thompson said.
It took almost exactly three years for the TGA to complete its investigation of Mrs Thompson's October, 2011 complaint, until it placed her adverse event report on its website in October, 2014.
This week she said she first contacted the TGA by phone in 2010, after two years of seeing different medical specialists to deal with the consequences of the surgery.
"You don't know where to complain when something like this happens. When I first phoned the TGA they said they'd had no other complaints. I kept ringing them. I kept saying to them 'What else have I got to do to get you to do something'?" she said.
"They just kept saying sorry, but I was the only complaint they had."
A Senate inquiry into Australia's health care complaints processes will consider a submission by a patient advocate arguing the complaints process has spectacularly failed women given transvaginal mesh devices to treat prolapse surgery.
While it is mandatory for manufacturers to report adverse events to the TGA, they have to be made aware of any adverse events experienced by women. The TGA has confirmed it is not mandatory for doctors to report adverse events experienced by patients.
Ms Chisholm and Mrs Thompson say the majority of women were completely unaware they could complain to the TGA, or even that mesh was classed as a "device" that came under the TGA.
When Mrs Thompson was told three or four years ago that she had irreversible nerve damage in her pelvis because of the mesh, she was advised she could try morphine patches to cope with the pain.
She rejected the idea. Her life is about managing pain and the stress that flows from it.
"I can't get up and down steps. I can't go out for a walk. I feel like I have barbed wire in my pelvis and every time I move it causes me pain," she said.
"To have one day pain free, when you've had years and years of chronic pain, is something I can't even imagine now."
The Therapeutic Goods Administration said it started monitoring urogynaecological meshes in 2008, with a review in 2010 that found complications were closely linked to the skill and training of surgeons.
By August 2014 after a clinical review it reassessed the clinical evidence for devices and took action against some manufacturers, including the cancellation of devices.
In a statement to the Newcastle Herald the TGA said it had strengthened its oversight of new applications for mesh approvals, including conducting its own clinical assessment of the evidence rather than relying solely on European approvals as the basis for approval in Australia.
Johnson & Johnson was contacted for comment.
Newcastle Herald

Friday, April 8, 2016

FDA Violations and Highest Risk FDA Bayer Essure

Original Essure Manufacturer Had Long History Of FDA Violations

By Michael Monheit    March 10th, 2016
In 2013, German pharmaceutical manufacturer Bayer acquired a small California-based company named Conceptus Inc. As the name suggested, Conceptus’ work in medical devices focused on reproduction, but the company made few waves with its first product line, a system of miniature catheters used to access Fallopian tubes.
It was what Conceptus eventually attached to those micro-catheters that would garner Bayer’s interest, and ultimately convince the multinational conglomerate that Conceptus was worth around $1.1 billion.
“Unanimous Approval” & Growing Profits
Conceptus had developed Essure, a metal coil implant that could be guided through the uterus and inserted into a Fallopian tube. After implantation, the body naturally reacts to the device, or more accurately, the polyethylene terephthalate (PET) fibers wound around the device’s nickel titanium coils. In textile manufacturing, PET is referred to by its more familiar name, polyester. But inside the body, according to Conceptus, PET has a different effect: triggering the growth of scar tissue.* Once the Essure implant has been inserted, the Fallopian tube coats the device in a thick layer of scar tissue, the company says, blocking both the tube itself and any eggs traveling to the uterus.
Essure’s innovative design certainly seemed promising, and Conceptus spent the years between 1998 and 2002 developing and testing the device. After “receiv[ing the] FDA’s most stringent review prior to marketing,” the agency’s so-called Pre-Market Approval process, Essure was approved for sale on November 4, 2002.  Essure was, and continues to be, a Class III medical device, among “the highest risk devices,” according to the FDA.
Few people are aware that the FDA uses two very different processes to regulate medical devices and pharmaceutical drugs. More often than not, medical devices are sent through a fast-track approval process, in which manufacturers need only show that their own device is substantially similar to one already on the market. In practice, though, that “substantial” similarity appears to be loosely interpreted. Many devices make it on the market, and thus into operating rooms and patients’ bodies, without any new safety or effectiveness testing.
But Essure was different, with a radically novel design, one the FDA guessed could cause patient’s significant harm. So the agency required clinical trials involving human subjects. By the time Essure was approved, in 2002, “the FDA had one to two years of safety and effectiveness outcomes data for Essure,” according to Jennifer Rodriguez, an FDA spokesperson who spoke to ABC News in October 2014. A “unanimous approval” followed, with the caveat that Conceptus would continue studying the device’s safety in several required studies.
Essure Soon Marred By Manufacturing & Side Effect Reporting Problems
In the meantime, obstetricians and gynecologists were beginning to adopt Essure as an alternative to tubal ligation, the industry standard for permanent female sterilization. Essure was easier, requiring only a 10-minute outpatient procedure to implant, Conceptus claimed. Citing the results of its clinical trials, which have now been widely critiqued, the coils were “safe and effective.”
Essure was on the ascendant, and Conceptus representatives were busy training doctors around the nation on how best to use the implants. By the end of 2003, according to a company shareholder report available here, “more than 14,000 patients” had been implanted with Essure, and no “pregnancies related to device failure” had been reported. Even more encouraging, Conceptus was turning a profit, reporting $442,000 in gross profits for the 4th quarter of 2003.
But for all the early signs of success, and Conceptus’ growing national reach, problems were beginning to crop up back at home, in Mountain View, California.
Spotty Record-Keeping & Rejected Raw Materials
During a series of routine inspections in June and July of 2003, FDA investigator Mark Chan noticed a discrepancy between Conceptus’ Lot History Records and the information included on Quality Assurance Forms, which track to show that a device is being made in the way its manufacturer said it would be.
Specifically, Chan found “hand-written” notes on the company’s records, which revealed that “raw materials and sub-assemblies (i.e., Inner/Outer Coil Sub-assemblies) were being rejected during” the manufacturing process. But that information wasn’t making its way onto the company’s Quality Assurance Forms, which would have notified Conceptus’ Quality Assurance department of the problem.

In a formal report, known as a Form 483, issued by the FDA when inspectors think they’ve discovered violations of federal law, Chan observed: “not all data […] are analyzed to identify existing and potential causes of nonconforming product and other quality problems.” The inspector also discovered that no “Material Review Reports,” which would have notified an entirely different board within Conceptus of the problem, were being generated either.
Why the materials were rejected in the first place is uncertain, but in Chan’s mind, Conceptus wasn’t checking up on potentially-defective raw materials, and it seemed to be a problem of communication between the company’s departments. In a recent lawsuit, one former Essure patient raised an even more troubling question: where did the rejected raw materials end up? In a trash bin or in an implant?
Conceptus Used Unlicensed Facility For 3 Years, California Health Department Finds
Whatever the answer, observers could not deny the severity of Conceptus’ next run-in with regulatory officials, this time inspectors at the California Department of Health. In 2008, the company was cited for manufacturing Essure implants out of an unlicensed facility.
Conceptus had been using the facility, state Health Department investigators said, for three years. By June 11, 2008, according to a narrative report completed by Health Department Investigator Christine Rodriguez, Conceptus’ licensing violations had been “corrected.” Finally, Conceptus was licensed to manufacture medical devices in California, but the company was far from out of the woods.
FDA Inspector Discovers Unreported Adverse Events
Between December 2010 and January 2011, FDA investigator Timothy Grome reviewed company documents and found evidence that Conceptus had failed to report multiple adverse events to the FDA.
Grome discovered two reports, sent to Conceptus by health professionals between July 12, 2010 and December 10, 2010, of women in whom the Essure implants had perforated their bowels, a complication that could “have caused or contributed to a death or serious injury.” But rather than pass these reports on to the FDA, as the company had with 41 other reports that did not involve bowel perforation during the same period, Conceptus appeared to have kept them internal.
A different report, in which a CT scan had revealed that a patient’s implant “was in 2 pieces […] with one of the pieces outside of the tube between the uterus and bowel,” had also been kept from the FDA, Gromes wrote in a Form 483 that would follow his inspection.
Conceptus’ apparent reporting violations between December 8, 2010 and January 6, 2011 were even more egregious. Gomes found no less than five reports of “perforation,” in which the coil implant had moved into a patient’s abdominal cavity or peritoneal cavity. But none had been submitted to the FDA as required, within 30 days of their receipt.
Gomes hit Conceptus with a related violation, since the coil’s obvious ability to move into the peritoneal cavity had never been included in the company’s official analysis of potential device failures.
Conceptus Denies Device Failure
After Gomes’ visit, the California Department of Health returned to Conceptus’ manufacturing facility for a routine inspection required by state law. While no new violations would be issued at this time, the Health Department’s subsequent report sheds light on the company’s response to the FDA’s findings.
In a letter sent to the federal agency on January 20, 2011, state health investigator Lana Widman wrote, Conceptus “disput[ed] the validity of [Gomes’] observations, regarding the reporting of complaints for peritoneal perforation.” According to Conceptus, the perforations were “a result of the physician’s misuse of the device or an error during insertion and not a failure of the device to perform as intended.”
Today, the FDA is busy drafting a new “black box” warning for Essure. While the final wording of this warning has not yet been published, it is likely to include “fallopian tube or uterine perforation,” alongside side effects like “persistent pain, irregular vaginal bleeding,” and the complication Conceptus failed to report nearly 6 years, “intra-peritoneal device migration.”

*This account of Essure’s mechanism of action has been called into question. In fact, according to several women who have filed Essure lawsuits, Conceptus’ own account of how the device works has changed. During a pre-approval meeting, plaintiffs claim, the company told FDA officials that “the trauma caused by [an] expanding coil striking the Fallopian tubes is what cause[s] the inflammatory response of the tissue,” not the PET fibers themselves.

Thursday, April 7, 2016

"Fuck You", Bayer Essure!

The Controversial Birth Control That Destroys Your Body

APR 6 2016 4:55 PM


Despite thousands of women's complaints about Essure—ranging from uterus perforation to miscarriage—the FDA allows the birth control device to remain on the market. Jessica Smith describes how her Essure implant turned her body against her.
Jessica Smith's unedited, angry comment is still on the FDA's website, much to her surprise. "You had an opportunity to remove Essure from the market. You blew it," it reads. Despite complaints from women who say they've experienced painful and severe side effects such as constant cramping, still births, ectopic pregnancies, and miscarriages from the sterilization implant Essure, the Food and Drug Administration has so far allowed drug maker Bayer AG to continue to selling its product.
"Like all forms of birth control, Essure is not perfect and women may become pregnant despite use of the device," Dr. William Maisel, the FDA's Center for Devices and Radiological Health director, said in a statement. Due to multiple lawsuits regarding Essure and a recent congressional investigation, the FDA announced in February that it would place a "black box" warning on Essure and order Bayer AG to conduct more safety studies on the device.
In the meantime, as Essure remains for sale but under federal review, the FDA has invited patients to leave public comments on its website about their experience with the controversial birth control implant. "You could have allowed us the opportunity to be compensated for our horribly damaged bodies, careers, relationships and lives. But you didn't. You blew it," Jessica's post goes on. "You blew it worse than the sex workers blew your Deputy for science at the FDA Center of Devices and Radiological Health back in 2012," she ends the post, crudely referencing the 2012 arrest of the FDA's Maisel in an alleged prostitution sting.
Jessica keeps a cheerful face on, but, like other woman who complain about Essure, she is also clearly bitter. She developed a painful condition called pelvic adhesion disease, in which her reproductive system is fused to her digestive system due to scar tissue. She and her doctors believe this is a result of the Essure implant.
In an interview at her apartment in North Texas, joined by two of her close friends, Jessica showed Broadly her extensive medical records and described the chaotic process of trying to find a doctor who might be able to "fix" her.

Jessica at home
After Jessica gave birth to fifth baby in 2013, she decided to go on a more permanent form of birth control. She considered her options: She could have had her "tubes tied,"—known medically as tubal ligation, the older and more common form of female sterilization—but she decided not to because she had no guaranteed paid sick days left to recover from surgery. Essure then seemed to be the more practical choice; Bayer AG claims that, unlike tubal ligation, Essure is a not a surgery but a quick, non-invasive outpatient procedure. Jessica says her doctor told her the recovery time would be a day.

She says she felt the pain immediately as her doctor implanted the device. She remembers being told to take an Advil. "She's a really conservative doctor, so the impression I had is she thought I was being kind of a weenie," Jessica recalls.
When Jessica got home that night, she says she started passing large tissue. According to Jessica, the nurse on call "said that sounded normal and I didn't need to come back to the doctor for that. And I was like, 'If that's normal, why isn't that one of the side effects listed?'"
You had an opportunity to remove Essure from the market. You blew it worse than the sex workers blew your Deputy for science at the FDA Center of Devices and Radiological Health back in 2012.
The bleeding didn't stop. Not for 10 months. Jessica says that she felt as though she was on her period through the entire 10-month span. She felt a constant pain in her abdomen, which vacillated between feeling bearable to being so intense that she could not stand, and therefore couldn't work.
She made regular trips to the emergency room. Doctors at the E.R. diagnosed her with vague conditions like "abdominal pain" and told her to return to her implanting physician. "I would hang my hat that you have an STD," she remembers one doctor telling her.
Another told her she was suffering from the "period from hell" and prescribed her hormonal birth control pills. Doctors gave her forms about things that cause pelvic pain—conditions like STDs, fibromyalgia, and endometriosis. Nothing pointed to Essure. "Their findings didn't show anything wrong. How can you treat what's not wrong?" she says.

Elizabeth Fluegge, another Essure victim who needed to have her device surgically removed

Jessica returned to her gynecologist's office, where they couldn't find anything wrong, either. At one appointment, she says, her implanting physician's partner "accused me of being a pill seeker and said it's not possible for Essure to hurt because it's so small." In the same breath, however, Jessica says the doctor told her that, unlike her partner, she does not implant Essure, "because leaving metal in soft tissue is not a good idea.'"

The retailer where Jessica works initially denied her paid sick leave but then gave her the days retroactively, allowing her to support herself and her children on the days that she was in too much pain to work. Jessica eventually realized that the pain was at its worst during the time in her cycle when she was ovulating and when she was menstruating.
A year later Jessica found what she believed would be a long-term solution to her pain: a relatively unknown surgery called "Essure reversal." So-called Essure reversals are expensive, complicated procedures performed by fertility doctors; they're not covered by insurance. They promise the woman the chance to get their Essure removed from their body without undergoing a drastic hysterectomy procedure. What's more, doctors who perform Essure reversals say that women who previously had Essure may even be able to get pregnant again.
Jessica chose a doctor in Florida, who charged $6,000 for the procedure. "He said a third of his patients get pregnant afterward," Jessica says. Jessica's fiancée took out a medical loan from a financial firm the doctor conveniently provided a link to on his website. Initially the surgery seemed to cure her pain.
But the relief didn't last, and the pain returned. "It would be kind of intermittent, and then the periods of pain would be longer and longer until I was just in pain all the time again," she says.
In Austin, Jessica visited a new doctor—one who has become popular with Essure patients for offering them advice on Facebook and setting aside time at his practice to meet with them. When he examined Jessica, she says, she was in so much pain he warned her that he may not be able to help. "There isn't a recognized safe method to remove Essure," Jessica says. "So basically it's just doctors making stuff up without much oversight or regulation or anything."
The doctor told her he could remove the scar tissue causing her pain, but that it may grow back, and if it did, she would need to see a different doctor to perform the next, more technically complicated surgery. Jessica took the gamble and underwent her second post-Essure surgery with him anyway.

Jessica's ovaries, the doctor's report explained, were attached to her pelvic side walls, and "her right ovary [had] a significant attachment to the colon.
"The patient, upon inspection of the pelvis, had extensive adhesive disease of the colon and small bowel... she also had severe pelvic disease from the top of fundus down to the endocervix," reads the doctor's surgical report, which Jessica saved. Jessica's ovaries, his report explained, were attached to her pelvic side walls, and "her right ovary [had] a significant attachment to the colon."
This surgery, like the last, only gave Jessica temporary relief. In pain and missing more work again, Jessica searched for another doctor and found one who still implants Essure in women but who also took her pain seriously.
On March 22, she scheduled her third post-Essure surgery. Beforehand, her doctor told her he would not perform a hysterectomy unless it was absolutely necessary.
"Out of surgery," Jessica texted me the next day. "I had a hysterectomy. "They took my uterus, cervix and tubes. I'm sad... This is not what I wanted. We are still paying for my reversal."
Her doctor had found so much scar tissue that he had little choice but to remove much of her organs. "He told me that Essure works very well for most women. Just not for me," she says. "'And 28,000 other women,' I said, because I am relentless."
Now Jessica is recovering and hoping to return to work. She recently busted a stitch open in her belly button after hiding Easter eggs with her children, but says it's otherwise going okay. She still has her job and is waiting for word on if her disability leave will be covered during her recovery time. In the meantime, she has joined a lawsuit against Bayer AG. Though the company's special FDA approval bars it from lawsuits, attorneys are attempting to sue the company anyway, and they recently won a surprising, minor success from a judge who allowed two claims against the company to go forward.

Jessica also leans on her friends for support. Her two friends and coworkers who sat in the interview with her have taken her to the hospital or watched her children when she was in too much pain to stand. And, in an effort to help Jessica with her medical bills, they even organized a surprise fundraiser last month, complete with a band and dozens of vendors at a local bar. The name of their event, written out in all-caps on the marquis of the bar, summed up the attitude that Jessica has about the last past two years of her life: "FUCK YOU, ESSURE."