Public Citizen sues FDA for information on Advisory Panel participants

Public Citizen v. Food and Drug Administration and Department of Health and Human Services

Documents:

Complaint (04/27/2016)

Related Press Releases:

04/28/2016

Description:

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names of professional colleagues and mentors, the amounts of grants received from private companies, and the names of unpublished articles.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.

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.

Sincerely,

_______________________________________________________

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.

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

'We've lost so much': Senate urged to act on failures over mesh device implants

April 13, 2016 - 8:15PM

Joanne McCarthy (FiDA highlights)

EXCLUSIVE

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

http://www.smh.com.au/federal-politics/political-news/weve-lost-so-much-senate-urged-to-act-on-failures-over-mesh-device-implants-20160413-go5obe.html

Read more: http://www.smh.com.au/federal-politics/political-news/weve-lost-so-much-senate-urged-to-act-on-failures-over-mesh-device-implants-20160413-go5obe.html#ixzz45hzjwkUb 

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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.

http://birthcontrolproblems.com/conceptus-fda-violations/

"Fuck You", Bayer Essure!

The Controversial Birth Control That Destroys Your Body

by Amy Martyn 

APR 6 2016 4:55 PM

COURTESY OF BAYER

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."

Justice in New Zealand? J&J DePuy Metal-on-metal hip replacement failure

Court date for faulty hip implant Kiwis

Wednesday, 06 April 2016

Kiwis who received faulty metal-on-metal hip replacements have only a few more months to get behind a class action against manufacturer DePuy.

Orders made by the High Court at Wellington have set a date for September 16, 2016, for patients that received the faulty ASR implants to join proceedings.

So far 26 claimants have signed up, but hundreds of Kiwis are thought to have received the faulty implants.

Meredith Connell, the lawyers acting on behalf of the claimants, said in a statement compensation was being sought for bodily injury including metal poisoning and for financial losses, such as a loss of earnings and the cost of care, as well as exemplary damages.

Some of the recipients have been left with permanent disabilities.

Meredith Connell said while DePuy paid for the claimants' revision surgeries, implant replacements and some out of pocket expenses, it has refused to pay compensation that meets the recipients' major losses.

The DePuy hip joint has been recalled worldwide. Photo / Natalie Slade

A hearing has been set down for September 21 to 22 at the High Court in Wellington which will look at addressing key questions, including whether the ACC bar applies where harm is caused to a New Zealander by an offshore foreign company.

In overseas litigation DePuy has argued the ACC regime prevents New Zealand victims from suing for compensation.

However, the lawyers stated the company's actions in designing and manufacturing the implants took place out of the country and it had not contributed to ACC through levies or taxes.

A similar class action in Australia settled for A$250 million ($277 million) after a 17-week trial in the Federal Court last year.

Patients who were implanted with DePuy's ASR XL Acetabular System or ASR Hip Resurfacing System who would like more information or to join the claim should contact the ASR victims group through their lawyers, Meredith Connell on hips@mc.co.nz or 04 914 0530.

One woman's toxic surgery ordeal

http://m.nzherald.co.nz/lifestyle/news/article.cfm?c_id=6&objectid=11500892

Saturday, 22 August 2015

David Fisher senior reporter for the NZ Herald.

Lynne McKay’s life was ruined for years by two bad hip replacements that left her in agony. What really hurts, she tells David Fisher, is that our health system still fails to hold anyone responsible.

By David Fisher

• Lynne McKay had both her hips replaced in 2007 with metal implants.

• The implants failed, causing her intense physical pain and violent mood swings.

• When the implants were eventually removed in 2012, a company representative attended the surgery and took photographs.

• A Health and Disability Commission investigation found no fault with McKay's medical care.

• About half the 5,000 metal hip implants given to New Zealanders have proved defective in some way but follow-up is left to the companies and surgeons involved.

"When I licked my lips I could taste metal," says Lynne McKay, who has had six hip replacements in six years. "There was a metallic film on top of the water in the toilet and I was having to clean it every day. I was peeing [metal] ions."

The new life she expected to come with her double hip replacement in 2007 never arrived. Instead came fears of madness and near-constant misery, which only partly abated when the metal hips were removed after being recalled as faulty in 2012.

The time in between was awful. Almost immediately, there was pain. Inside McKay's body, the connection between the ball and the cup created a "grinding" which produced an "ionic soup".

When McKay walked, she heard "click, click" as the ball ground against the edge of the cup. Unknown to her, there were "actual chips coming off the back. And the [metallic] dust". The joints - when they eventually came out - were abraded, ground and scratched.

Her body was "trying desperately to sort it out" by collecting the metal fragments into tumours around the hip area. "There was a tumour the size of a small hen's egg."

Then came other changes. "About two years after having my hips done, in hindsight, I started to experience toxicity."

McKay had yellow, green and blue curtains, which first dulled, and then lost their yellow tones. At first she thought the curtains were fading, then she realised she was losing her ability to see colours. She started to experience hearing loss and tinnitus, and had frequent unexplained rashes.

McKay thought she was losing her mind. "I couldn't hold a thought. I was always in tears. My words weren't coming out right. I was cutting my nose off with all my friends. I thought I had Alzheimer's. I really thought I was losing the plot."

With her life falling apart, McKay tried harder to keep it together. She walked the streets for hours doing letterbox drops to build a massage business, which was suffering. "I was desperate for work. I was begging people. I really lowered my professional life. I was fighting for my life on a lot of different levels without knowing what was going on."

Understanding arrived in 2012, when the Stryker Mitch THR (total hip replacement) System was subject to a recall notice. A blood test showed McKay had high levels of chromium and cobalt in her bloodstream. Normal levels are between zero and 20 microscopic nanomoles per litre. McKay had 326 nmol/l. Cobalt was also high - safe was 0-16 nmol/l but she had a 378 nmol/l reading.

Mackay believes her metal hips poisoned her. It's a belief shared by other implant patients with elevated cobalt and chromium readings. The British Medical Journal raised this in 2012 in a story on regulatory failure around metal-on-metal implants, saying the ongoing uncertainty around the impact of the metal ions would never be tolerated in drug regulation.

There is still argument in medical circles as to whether the high levels have any effect, even though concerns have been raised for more than 40 years. The official position is that the long-term effects are unknown.

For McKay, not knowing is unacceptable. She says efforts should be made to find out the effects of metal ions in her body, rather than adopting a "wait and see" approach.

But then, she's long lost faith that the medical system will listen to her.

Back when she was a believer, the former registered nurse anticipated life-changing results from the metal hips surgeon Rocco Pitto put into her body during surgery at Middlemore hospital in 2007.

She was 50 at the time and life had become increasingly painful. "I got to a place where I could only walk to the letterbox with two walking sticks."

Diagnosed with dysplasia, a condition in which abnormal growths form at the joints, she had both hips replaced in March 2007. In hip replacements, the femur is removed for an artificial replacement; in McKay's case, the metal stem was attached to a metal ball that moved inside a metal cup, mimicking the worn-out original.

The metal hip replacements were enjoying a resurgence in surgical popularity, with the belief they would be more durable and last longer than ceramic or plastic alternatives. But by 2010, concerns were raised widely about the safety of metal-on-metal with the recall of a DePuy-branded device.

In April 2012, the recall notice for McKay's device went out.

The Lancet medical journal raised the alarm with a study showing 6.2 per cent of implants had to be replaced five years after being put in. It compared to 2.3 per cent for ceramic-on-ceramic implants and 1.7 per cent for metal-on-plastic types. British figures showed McKay's implants - the Stryker Mitch THR System with an Accolade femoral stem - had a revision rate of 8.8 per cent over four years. The alert to surgeons in Britain included advice that they screen patients annually for the presence of chromium and cobalt in the body.

In New Zealand, documents released under the Official Information Act show Stryker initially wanted to class the notice as a "safety alert", saying it no longer distributed the device in New Zealand. Medsafe wrote back to say it did not agree and insisted the notice be classified as the more serious "hazard alert", effectively matching the British response.

The letter announcing the recall on the Mitch head went out to surgeons on April 13 2012. Under the New Zealand system, the state has no role to play in contacting surgeons.

Instead, the regulator - Medsafe - asks the medical device company to make contact with the surgeons to whom it sold the implants and for them to notify patients. The OIA papers show Stryker didn't hear back from all surgeons (who it calls "customers" in emails to Medsafe) who used the device until three months later on July 6 2012.

McKay believes her metal hips poisoned her. Photo / Jason Oxenham

In McKay's case, Pitto's recalls were handled through Middlemore Hospital. Furious at the impact on her life over the past five years, she says she developed strong feelings of anger and frustration towards Stryker.

She wanted to sue. She wanted justice: "I had asked for medical photographs to record the damage to my hip. The kids had started to tell me I needed to collect things for class action."

She wanted to get Stryker into court and sue the company for the grief it had caused.

When McKay went into surgery in July 2012, she says she had no knowledge of - and did not consent to - a Stryker representative being among the gowned and masked surgical team preparing to operate. She says she objected strongly and was even more upset on waking after surgery to see on her notes: "The representative of Stryker Medical was attending today's surgery and also took some photos."

McKay: "That's when I lost it. Those photos were my evidence of what had happened to me." The faulty parts were also removed.

Though Pitto later told a Health and Disability Commission investigation he did discuss consent with Ms McKay, the Counties-Manukau District Health Board has said he didn't need her permission to have a Stryker representative in surgery and didn't ask her. The board also told the Herald - and Ms McKay says it's the first she's heard - that the Stryker photographs were not of the surgery but only of the faulty parts, removed from her body. She can't see the images to assure herself - the board says Stryker has deleted the photographs.

There are no signed consent forms showing permission was granted for either Stryker's presence, or the company's decision to take photographs or for the removal of the faulty parts. In all those cases, the health board says no consent was needed. It says consent is not required when someone is part of a surgical team.

For McKay, it felt as if the system was aligned against her - and even aligned with the company she blamed for the faulty parts.

In the end, McKay had a further three operations - a total of four hip replacements in 13 months after the recall. The replacement of the first metal hip in July 2012 was a failure - it dislocated less than two months later and needed replacing in November 2012.

One foot after another, neither working properly, "I fought to keep moving," says McKay. The replacement hip went in backwards so was replaced again on May 29, 2013. And then it was the other side. The right hip was revised in August 2013 and she then went into recovery for a year, getting $257 a week from ACC with a small accommodation top-up. Now, at least, "the metal taste was gone and energy levels were back up. But I'm in constant pain." She hisses with frustration.

"I'm sick of saying that actually. I walk like a drunk woman. I've no sense of stability in my hips. It hurts me to walk upstairs. My body is managing the indiscrepancies in core balance muscles but I pay for it in other ways. The body reorganises itself around weak muscles.

"I'm back massaging but I have to do it differently. I do my gardening and my housework on my knees."

McKay doesn't want anyone's sympathy. She's angry with nothing to strike out at. A complaint to the Health and Disability Commission talked of the "benefit of hindsight" and said Pitto's professional practice was appropriate given the knowledge at the time. Pitto declined to speak to the Weekend Herald.

And that's it. The metal hips that went bad inside her body were never approved for use in New Zealand, because our system doesn't require approval for medical devices.

The surgery took place largely in public hospitals, paid for with public money, and the taxpayer has since supported her recovery with a (meagre) salary supplement. ACC has never kept track of how much it cost the public to cover surgery to replace defective products or to cover rehabilitation afterwards.

No public body is taking action to discover the extent of the issue and whether it could have been handled better. When a group of Kiwi patients set off to Britain courts to unsuccessfully sue Stryker for negligence, they did so without Government support.

A spokeswoman for the Counties Manukau District Health Board pointed to a Health and Disability Commission investigation which found "the care provided to Mrs McKay was appropriate in the circumstances.

The DHB acknowledges the distress and pain that Mrs McKay has suffered as a result of the metal on metal hip implant and apologises that she had to undergo further surgery to replace the device."

A spokeswoman for Stryker said the company had "strict policies" guiding the behaviour of its staff in and out of operating theatres and investigated any complaints against them. The company would not provide a copy of its policies and would not comment on the specific case.

The scale of the issue is difficult to gauge. A Medsafe briefing counted about 1200 metal-on-metal devices that were recalled or subject to hazard notices. A further 1300 metal-on-metal devices had failure rates so high that surgeons were advised to check on their patients regularly.

In some cases, the surgeons who carried out the operations have died or retired - Medsafe's hope is that their successors will reach out on their behalf.

Health Minister Jonathan Coleman's office hasn't had any briefings on the issue in the past two years.

A spokeswoman says the regulatory system worked as it was meant to - but that system is about to be completely overhauled. "Health care is always rapidly changing, including emerging technologies, and we need to look at how legislation can better support that."

A law for the new regulatory scheme is expected to be put before Parliament next year and will "regulate the quality, safety and efficacy/performance of all therapeutic products across development and manufacture, market entry, and use".

Among the patients given the 2500 implants that were never good enough, McKay and a small cluster of unknowns have had extreme adverse experiences.

"I worry about what the future holds after being toxic for so long," McKay says. "Sometimes you just have to suck it up and get on with it - but somebody should be accountable."

Implants approved before risk known

Metal hip implants were recognised as a risk to patients after they were approved for use, says a surgeon who advised the Australian Government on the technique.

Surgeon Peter Devane - a hip replacement and revision specialist - says metal implants and metal caps on affected joints grew in popularity through the 2000s although use varied around the world. New Zealand was more conservative than most.

Devane was part of the system that cleared the devices for use in Australia. Between 1998 and 2008 he sat on the orthopaedic committee of Australia's Therapeutic Goods Association, the body that advises government on which devices can be used. The Australian system approved products under guidelines developed by the Global Harmonisation Task Force, a collection of volunteer regulatory bodies and medical device companies from around the world. At the time, metal-on-metal hips were in the "2b" category which meant they faced few regulatory hurdles because they were considered to be a modification of a previously-approved product.

From about 2007, work began to upgrade the categorisation to reflect a higher risk, but metal-on-metal hips had already gone through. Devane says governments were left playing catch-up. A British Medical Journal article later labelled it regulatory failure.

In New Zealand, the use of the products peaked in 2007. "Then those reports on metal-on-metal started coming out. We were aware of them - regulatory bodies were aware of them. By 2010, metal-on-metal was down to 3 per cent (of hip replacements)."

The comparative low number of replacements here - about 5000 replacements - tempered the surgeons' responses. "We didn't want to create a panic culture because it's not as big a problem (as abroad)," says Devane.

New Zealand's regulator Medsafe doesn't have an "approval process". In a statement, it told the Herald: "The [New Zealand] legislation does not require any form of pre-market assessment of medical devices." Medsafe takes guidance from other regulatory authorities -including the TGA - while medical device companies sell direct to surgeons.

Medsafe has "no mandate to approve medical devices or to monitor their import into the country", the statement said. Instead, companies are obliged to register devices on a database. "A notification on the database does not signify that a medical device has been 'approved' in any way