Showing posts with label preventable harm. Show all posts
Showing posts with label preventable harm. Show all posts
Thursday, September 13, 2018
Wednesday, June 7, 2017
Bayer Essure: Banned in Finland, the Netherlands, England, Wales, Scotland, Northern Ireland and Brazil
Holly Kelly Ennis
June 7, 2017 FiDA highlight
Victims of Essure celebrated again today after learning that the controversial Essure Sterilization device will be discontinued in the United Kingdom as of September 1, 2017. This follows on the heels of Essure being banned by Brazil in February and recently discontinued in Finland and The Netherlands, with rumors of other countries to follow by the end of the Summer. Bayer recently confirmed it will discontinue sales in the United Kingdom set forth in the letter below:
As Bayer discontinues the sale of the Essure device or countries ban it outright, this exerts greater pressure on the FDA to take affirmative action regarding pulling the device from the market. For over three years, since the Essure Problems Administrators first shared their valid concerns regarding the device, they have heard the same tired response from the FDA, "We understand your frustration. We assure you, Essure is a high-priority issue for the Agency and we continue to take feedback like yours into consideration." Obviously, the FDA is not hearing the Group's concerns, nor is it a high priority. In fact, despite repeated pleas from the Group regarding the making the Black Box Warning mandatory to physicians, the FDA designated it as a "guidance." Accordingly, over 200 hundred women have contacted the Group since the BBW was implemented on November 15, 2016 to report that doctors failed to mention the BBW or use the Patient Decision Checklist.
The FDA responded yesterday that it, "continues to review the available information about Essure, including reports of problems submitted to the FDA." These reports now total over 15,000 with over 9,000 reports of surgical removals since 2009. How long will the FDA continue to "review" the horrific stories of ladies significantly injured by the device before it takes some definitive action and revokes the PMA for the device? The job of the FDA is to protect the health of American citizens, not line the pockets of pharmaceutical and medical device companies. FDA, it is time. Do Your Job.
Questions regarding the Essure Sterilization Device can be directed to attorney Holly Ennis at 1-800-856-6405 or visit us online at www.Ennislaw.com
http://www.ennislaw.com/blog/more-pressure-bayer-and-fda-essure-discontinued-united-kingdom/
Tuesday, June 6, 2017
The Biggest Global Health Disaster of Our Time: Surgical Mesh
PUBLISHED: 20:06 06 June 2017 FiDA highlight
One in three women could be suffering in silence with mesh implant problems in a women’s health scandal that has been called the biggest disaster of our time.
One of the risks of pelvic mesh implants is loss of sex life due to chronic burning and cutting pains or chronic infec tion. This has led to marriages breaking down. The risks are unacceptable say campaigners globally. PHOTO: Pexels.
The shocking figures come as a Scottish surgeon this week told BBC Radio that mesh has a: “Whopping 15 per cent of women who develop serious complications.”
Speaking on the Kaye Adams show, Dr Wael Agur said: “No woman should get a life long disability just because of a surgical treatment of urinary incontinence.
“One life ruined is one too many and it’s absolutely unacceptable that a patient will take pain killers for the rest of her life.”
Instead, he said surgeons should move back to two alternative, time honoured surgical fixes, with risks which are acceptable.
The mesh implant scandal was featured on the BBC Victoria Derbyshire show in April. Seen here interviewing reporter Kath Sansom, Claire Cooper and Kate Langley.
Campaigners globally say pelvic mesh risk, quoted in all countries as one to three per cent, is vastly under estimated and based on studies which are either short term, run by medics with conflicts of interest or on animals who cannot speak of the pain or lost sex lives due to intense burning and cheese wire pains in their vaginas.
As the scandal unravels women are calling on governments worldwide to ban mesh implants, used to fix incontinence and prolapse, often caused by pregnancy and childbirth.
Campaigners, Elaine Holmes and Olive McIlroy fought for a suspension on mesh in Scotland in June 2014 but it was re-instated in March 2017 amid claims of a whitewash independent review - now being scrutinised by an independent expert.
Scottish MPs Neil Findlay and Jackson Carlaw have called this a disaster on asbestos proportions.
Leaked document of the English Group Working Party into mesh implants - group members agreed to try to reduce media impact of mesh relating to Yellow Card reporting. Patient reps have not been invited to any meetings for more than a year. PHOTO: Contributed
Welsh MP Owen Smith has called it the worst health scandal he has seen in his time as a politician.
Australian senator Derryn Hinch has said this is the biggest women’s health issue since the morning sickness drug thalidomide.
American lawyer Ben Anderson said: “This is the greatest women’s health crisis of our generation.”
New Zealand politician, Christine Rankin, who suffered agonising mesh implant pain and was told by her surgeon to get used to living with it, said: “Mesh is dangerous and it should be used with caution and the truth needs to be told about it.”
The MHRA commissioned a study into mesh complications. The result is the York Report from 2012.
Problems reported by women globally include leg pain making it difficult to walk far, pain in buttocks and groin making it painful to sit for long, the sharp-edged mesh cutting into tissues, nerves or even busting through vaginal walls, chronic infections and allergic reactions to the plastic material.
Some women are left disabled in wheelchairs and others have to use sticks to help them walk.
Studies with high risk figures include:
• An American study which show 42 per cent of women suffer complications - 20 per cent of them serious.
• An Italian study which found risk rate was 30 to 40 per cent.
• An American review which says the risk of pain following a mesh operation is 31 per cent.
• A Canadian study which found problems for 27.9 per cent of women.
• A Canadian review that says 22.3 per cent of women risk suffer painful infections.
• A Canadian study discovered poor outcomes for at least 15 per cent of women.
• The FDA say the hooks used to implant mesh can cause damage for up to almost 30 per cent of women.
Almost 20 years after the operation was launched, women say the world must wake up to the fact that mesh implants are not a “gold standard” fix.
Surgeon Firouz Daneshgari, said: “By any modern industrial standards of quality, a 30–40 per cent rate of adverse events is simply unacceptable.
“Can any of us imagine what would happen if one-third of all cars, computers, food packages, or any other commodity we purchase would fail or result in recalls?
“Moreover, it is unlikely that the manufacturer would remain in business after such recalls and failures.”
In the UK, the NHS and MHRA say the benefits outweigh the risk, which they say is as low as one in 100 women.
However, they base their figures on a review called the York Report, carried out in 2012.
Campaigners say the studies in it are flawed as many are short term - as little as six weeks post operation - so do not capture the true picture. Some problems don’t cut in until months or years later.
The UK York Report says the risk of losing or suffering a reduced sex life can be as high as 13.5 per cent while the risk of pain can be as high as six per cent and erosion as high as 5.8 per cent.
However, it averages out its figures of risk to just one to three per cent - a figure quoted in most UK patient information leaflets.
Sling The Mesh campaigner Ann Boni said: “How bad has this got to be before the authorities admit mesh has lifelong disabling risks?”
If a woman suffers complications, then removal is major surgery, Mrs Boni added, but said many surgeons push women to only have part of the mesh tape taken out.
A partial removal takes around half an hour while a full removal can take up to two hours - making it clear that partials are preferred on a cost basis.
A survey carried out by patient support group, Sling The Mesh, found that a full removal can relieve symptoms for almost six out of ten women - 57.14 per cent.
A partial removal, however, left only two out of ten women - 21 per cent - feeling like it had improved things.
Mrs Boni said: “Mesh is designed as a permanent implant and was launched onto the market without the benefit of robust, quality clinical trials. “No thought was given to how it was going to be removed when complications arose.
“It is easier to perform a partial removal but what must be impressed on surgeons is that if women seek removals they must be given full removals because at least the patient stands a chance of getting some quality of life back.
“Partial removals can leave women worse off months or years down the line as mesh continues to shrink, migrate into pelvic organs, harbour infection and the foreign body reaction continues to activate an adverse immune response”
“Surgeons know that if there are problems it is very difficult to fix. So why do they still implant it?”
• A study called Prospect said more than one in ten women suffer complications following a prolapse mesh operation.
• A study, which includes UK mesh removal specialist Suzy Elneil as author, says there should be a red card system for new medical devices. It also says not all women should be considered for mesh as previous pelvic or lower abdominal surgery may mean adhesions. Also some women may have a congenitally distorted pelvis or been traumatised by other causes such as childbirth. http://www.europeanurology.com/article/S0302-2838(11)00868-2/pdf
http://www.wisbechstandard.co.uk/news/women-step-up-pressure-to-ban-pelvic-mesh-implants-the-biggest-health-disaster-of-our-time-1-5051244
Monday, January 4, 2016
Pelvic Surgical Mesh Regulation: Too Little, Too Late!
FDA strengthens requirements for surgical mesh for the transvaginal repair of pelvic organ prolapse to address safety risks
For Immediate Release
January 4, 2016
FiDA highlight & comment
The U.S. Food and Drug Administration today issued two final orders to manufacturers and the public to strengthen the data requirements for surgical mesh to repair pelvic organ prolapse (POP) transvaginally, or through the vagina. The FDA issued one order to reclassify these medical devices from class II, which generally includes moderate-risk devices, to class III, which generally includes high-risk devices, and a second order that requires manufacturers to submit a premarket approval (PMA) application to support the safety and effectiveness of surgical mesh for the transvaginal repair of POP.
The orders will require manufacturers to address safety concerns, including severe pelvic pain and organ perforation, through a rigorous PMA pathway to demonstrate safety and effectiveness. The actions apply only to mesh devices marketed for the transvaginal repair of POP. These orders do not apply to surgical mesh for other indications, like stress urinary incontinence (SUI) or abdominal repair of POP.
“These stronger clinical requirements will help to address the significant risks associated with surgical mesh for repair of pelvic organ prolapse,” said William Maisel, M.D., M.P.H., deputy director of science and chief scientist for the FDA’s Center for Devices and Radiological Health. *
“We intend to continue monitoring how women with this device are faring months and years after surgery through continued postmarket surveillance measures.”
Surgical mesh has been used by surgeons since the 1950s to repair abdominal hernias; in the 1970s, gynecologists began implanting surgical mesh for the abdominal repair of POP and, in the 1990s, for the transvaginal repair of POP. In 2002, the first mesh device with this indication was cleared for use as a class II moderate-risk device, and there are five manufacturers who are currently marketing this product.
Over the past several years, the FDA has seen a significant increase in the number of reported adverse events associated with the use of surgical mesh for transvaginal POP repair, and an advisory panel of experts recommended in 2011 that more data is needed to establish the safety of the device. The FDA has since taken several actions to warn doctors and patients about the use of surgical mesh for transvaginal POP repair.
Manufacturers of surgical mesh to treat POP transvaginally will have 30 months,(June 2018) as required by federal law, to submit a PMA for devices that are already on the market. Manufacturers of new devices must submit a PMA before those devices can be approved for marketing.
POP occurs when the muscles and tissue of the pelvic floor become stretched, torn or weakened and can no longer support pelvic organs such as the bladder, bowel or uterus; as a result, the organs drop from their normal position and bulge (prolapse) into the vagina. While not a life-threatening condition, women with POP often experience low back pain or pelvic pressure, painful intercourse, constipation or urinary problems such as leakage or a chronic urge to urinate.
Doctors may perform surgery on women with POP who have significant symptoms, often using a minimally invasive transvaginal technique to reduce recuperation time. Surgical mesh may be permanently implanted during this surgery to reinforce the weakened pelvic floor muscles and repair POP, but over the past several years the FDA has received thousands of reports of complications involving the use of mesh for transvaginal POP repair. The most common problems reported include severe pelvic pain, pain during intercourse, infection, bleeding, organ perforation and urinary problems from mesh eroding into surrounding tissues.
To warn doctors and patients about the use of surgical mesh for transvaginal POP repair, the FDA has:
- Issued safety communications in 2008 and in 2011 warning doctors and consumers about an increase in adverse event reports related to mesh used for urogynecological procedures;
- Convened an advisory panel in September of 2011 to solicit recommendations on actions to take regarding urogynecologic surgical mesh for transvaginal POP repair;
- Issued orders to manufacturers in January 2012 to conduct postmarket surveillance studies to address specific safety and effectiveness concerns related to surgical mesh used for transvaginal repair of POP; and
- Issued two proposed orders in May 2014 to reclassify the devices from class II to class III and to require manufacturers to submit a PMA application.
Manufacturers may choose to submit a PMA before the 30-month deadline.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm479732.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery
Wednesday, August 12, 2015
The FDA/CDRH FAILURE: unsafe & ineffective high risk devices cause PREVENTABLE patient harm
Evidence Limited for Most High-risk Device Approvals
Marcia Frellick
August 11, 2015
The quality and amount of evidence used by the US Food and Drug Administration (FDA) to support bringing high-risk devices to market varies greatly, new research indicates.
A study by Joseph S. Ross, MD, MHS, from the Yale University School of Medicine in New Haven, Connecticut, and colleagues, published in the August 11 issue of JAMA, found that nearly all devices the authors studied from 2010 to 2011 were cleared on the basis of two studies: one pivotal study (studies that served as the basis of FDA approval) and one nonpivotal study. Nonpivotal studies are typically conducted to assess device feasibility, enrolling a limited number of patients to examine performance and guide premarket development and clinical use.
"[M]ost devices have been or will be evaluated through only a few studies, which often focus on surrogate markers of disease in small numbers of patients followed up over short periods of time and study indications that differ from the original FDA-approved indication," the authors write.
In the United States, the FDA most often grants marketing approval through the premarket approval pathway for high-risk medical devices, which the authors describe "as those that support or sustain human life, prevent illness, or present potential, unreasonable risk to patients."
The premarket approval pathway requires that premarket clinical evidence provide reasonable assurance the device is safe and effective.
The FDA has been expediting patient access to new technologies by being more flexible with premarket evidence requirements for devices, but concerns have been raised that the studies supporting approval lack adequate rigor and are prone to bias.
The current study shows that between 2010 and 2011, the FDA granted initial marketing approval for 28 high-risk therapeutic devices through the premarket approval pathway.
Ten of those devices (35.7%) were recalled at least once, with 1 (3.6%) being the subject of a class 1 recall, meaning it presented the highest risk (reasonable probability of serious health problems or death). One device was voluntarily withdrawn from the market.
Emphasis Shifts to Postmarket Studies
"As the FDA adopts more flexible premarket evidence requirements for devices in an effort to expedite patient access to new technologies, the information generated from post market studies will become increasingly important in guiding regulatory and clinical decisions," the authors write.
However, they note that only about 13% of postmarket studies were completed between 3 and 5 years after FDA approval.
No postmarket studies were identified for 17.9% of devices, and three studies or fewer were identified for 13 (46.4%) of devices overall.
"Our findings of limited premarket evidence generation and few FDA-required postmarket studies highlight the need for continued study, either through manufacturer-initiated or investigator-initiated studies, to advance postmarket understanding of device safety and effectiveness," the authors write.
About 85% of the postmarket studies the authors identified "were not initiated in response to FDA requirements, and 40% were conducted without manufacturer support."
Dr Ross has received grants from the Pew Charitable Trusts and is supported by the National Institute on Aging and the American Federation for Aging Research. He and a coauthor receive support through Yale University from Medtronic and Johnson & Johnson; from the Centers of Medicare & Medicaid Services; and from the FDA to develop methods for postmarket surveillance of medical devices. Another coauthor is supported by the National Heart, Lung, and Blood Institute Cardiovascular Outcomes Center. Another coauthor reports he chairs a scientific advisory board for UnitedHealthcare. Another reports having received a contract (through the University of Colorado) from the American College of Cardiology.
JAMA. 2015;314:604-612. Abstract
http://www.medscape.com/viewarticle/849349
Friday, July 24, 2015
Bayer Essure: A Device of Torture with No Remedy
A DEVICE PROMISING SAFE, PERMANENT BIRTH CONTROL DELIVERS PAIN, WOMEN SAY
In hindsight, Dr. Shawn Tassone says he and his colleagues were perhaps too eager to implant metal coils in their patients' fallopian tubes.
"We do kind of treat women's health a little bit on the sly here in the United States," says Tassone, who practices at Austin Area Obstetrics, Gynecology and Fertility. "I think if you were to tell men you [were putting] a metal coil in their vas deferens ... men probably wouldn't do it. Like, 'Are you kidding me, you're going to put a piece of metal in my testicle?' But with women, it's just kind of OK."
Like many medical problems that started out as promising breakthroughs, the coils seemed to be a good idea to doctors some 750,000 procedures ago. For years, obstetricians and gynecologists have searched for a way to sterilize women without cutting into them, for a birth control method both permanent and non-surgical. In 2000, a small company called Conceptus said it had the answer: a small coil that looked like the spring in a ballpoint pen, called the STOP-2000. One coil would go in each fallopian tube, causing the tube to react and grow scar tissue, keeping the product in place forever.
The company began testing on women in the United States, England and Australia in 2000. Women who participated in the clinical trials were promised they were taking part in research that would help many others. "At the very least," says an early consent form, "your contribution will benefit the search for a non-incisional way for women to be sterilized."
Several of the women in the trials say they experienced bizarre, painful side effects, but were told they couldn't be caused by the device. Years would pass before they found other women with complaints like theirs, well after the STOP-2000 had been approved by the Food and Drug Administration under a more marketable name: Essure.
Tassone was an early user of the Essure. Initially, doctors were required to test their patients for any allergies to nickel, a component of the coils, but then the company lifted the requirement. "That opened the floodgates; then more doctors were doing it," Tassone says. Conceptus told doctors they could perform Essure in their offices, no hospital visit necessary, making the procedure even more cost-effective. At Tassone's practice, placing an Essure would earn him around $400. The doctors were trained by pharmaceutical sales representatives who are not doctors, a practice health advocates criticize but which the manufacturer defends.
"The sales reps are not required to have any medical degrees, but this is very common in the device industry," says Dr. Edio Zampaglione, an executive and physician at pharmaceutical giant Bayer, which purchased Essure two years ago. "It takes somewhere between six to eight months for these sales reps in the beginning to get internally certified and go out and train physicians."
Tassone volunteered as a consultant for Conceptus, fielding questions from doctors near him, attending conferences and seeking advice from sales people during the procedures. In a span of six years, he implanted the Essure more than 200 times, he estimates. If any women did complain to him afterward, he says he wouldn't have connected it to the Essure.
Then a doctor in Florida called him two years ago. A woman whom Tassone had implanted with Essure had moved there and then got pregnant. The woman's new doctor thought Tassone should know. "I thought the Essure was supposed to be pretty infallible," Tassone says. The call was an eye-opener. He searched the Internet and found Essure Problems, a grassroots Facebook group that for many women has been the only formal recognition of their pain. Every day the group of nearly 20,000 women is piled with new complaints about side effects from the device, many that defy explanation: distended bellies the women developed shortly after getting the Essure, migraines, constant bleeding, pain near their abdomens, skin rashes, lethargy and heavy periods, to name a few.
Some of the complaints women had about their minds and bodies sounded like borderline conspiracy theories to Tassone, but a pattern emerged in many of the reported side effects and medical evidence: Patients have gone so far as to post X-rays in the group, showing Essure devices that had somehow traveled out of their fallopian tubes and into other parts of their bodies, some in their uteri or colons. Spin-off groups were formed for Essure women who got pregnant. Tassone stopped implanting the device and began treating patients who didn't want Essure anymore.
But Essure isn't like other forms of birth control, which all cause side effects for a percentage of unlucky users. Essure is designed to stay stuck in a woman's body forever, embedded in inflamed scar tissue. "There is no good way, from the company, from the manufacturer, to take it out," Tassone says. "You would think that they would devise a way to remove their product that doesn't cause significant damage to a woman."
Or, as the FDA's website explains: "Essure is considered a permanent form of birth control and therefore is not intended to be removed."
So, women who no longer want Essure in their bodies anymore have limited resources beyond a support network of others bitter at the medical system they say failed them.
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Dylan Hollingsworth
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On the ground floor of the Texas Health Huguley Hospital in Burleson, Dr. Robert Smith advertises his infertility clinic in neon lights. "ESSURE REVERSALS," reads a glowing pink and blue sign on the door. Two paintings hang in his waiting room. In one, a surgeon and his team operate on a patient as Jesus stands behind the surgeon, guiding his hands. The other shows a young, male doctor looking pensively into the distance. Again, Jesus stands behind him.
Smith takes credit for being the first doctor in North Texas to remove Essure from a woman, and, like the doctors in the paintings, he says his hands are guided by something holier than medical science. "To my knowledge, I had, in the DFW area, the first successful removal of the Essure inserts," Smith writes about himself in one of the several books he's self-published about biblical prophecies that Jesus will rise again. "The above is mentioned not for accolades but rather to acknowledge the gifts that God has entrusted to me."
In person, Smith has a friendly manner, less intense than his literature might suggest. He wears a bow-tie and his hair slicked back. A woman's uterus is embroidered above the right breast of his doctor's coat.
Smith isn't ideologically against birth control, he says, nor will he comment on whether Essure is an inherently flawed medical device. His specialty has been reversing tubal ligation, the older, more common and most effective form of female sterilization. He learned how to do Essure reversals more recently, using similar techniques. Before surgery, he asks his patients to pray with him.
Smith is one of the few doctors near Dallas who will operate on women who don't want Essure anymore. On Texas E-sisters, the local spin-off of the national Essure group, the women compiled a list of trustworthy doctors in the state who can take out Essure. The list contains only 15 names. To get doctors and insurance companies to take their complaints seriously, the women advise each other on how to articulate their problems in the physician's office.
"I think there's this sort of underground carrying of information [in the Facebook group] that you're not going to get from looking at your insurance provider directory," says Dr. Eric Sills, an infertility specialist in Carlsbad, California, who has studied the prevalence of pregnancies with the device.
Patients have a litany of horror stories about doctors who unsuccessfully tried to remove Essure: doctors who simply pulled the coils, causing them to break, or doctors who morcellated them, using a tool to grind up the Essure coils that can release metal pieces into the patients' bodies.
"I looked like I had freaking shrapnel in me," says Angie Firmalino, a mail carrier in New York City who founded the Essure Problems group. Many women assume that the only way to get Essure safely out of their bodies is through a hysterectomy, the kind of invasive surgical procedure Essure was supposed to help women avoid. Patients find that many doctors are reluctant to perform the drastic surgery. Woman instead are told to take medication to deal with pain, or are diagnosed with a "hormone imbalance" or other illness.
"The Essure removal by hysterectomy is not a difficult procedure, but what happens is a lot of us get scared, a lot of us don't want to manage patients with the Essure device in place because we've never had to do surgery like that, so we get scared and so we pass the buck to another doctor," says Dr. Julio Novoa, an OBGYN and plastic surgeon in El Paso and one of the 15 doctors whom the Texas E-Sisters recommend. He counsels women for free regularly on Facebook. On his insurance forms, he makes sure to explain the immediate reason for performing a hysterectomy: not the Essure, but the pain in the woman's abdomen.
Dr. Smith, in Burleson, doesn't just offer Essure patients the basic hysterectomy. He also tells women with Essure they could get pregnant again if they undergo a more complicated surgery called the Essure reversal. He is one of only a few doctors in the state to advertise the procedure. It costs $6,000, gets no coverage from insurance providers and must be paid in cash. "I've been burnt by checks, so after a while you just don't take them," he says.
There's no published data that Smith or any other doctor knows of studying the safety or efficacy of Essure reversal surgeries. By Smith's own count, he has performed reversals on 11 women. "My success rate after 12 months of trying is 66 percent," he says of patients who conceived. He acknowledges that Essure patients who do get pregnant face an unknown risk of ectopic pregnancy, a sometimes-lethal type of pregnancy in which an embryo implants itself outside the woman's uterus. In interviews, IVF specialists tend to be more optimistic about the safety of Essure "reversals" than other types of gynecologists. "If the device itself is supposed to cause inflammation and scarring inside the tube, then if you're going to remove the device you're going to have damage inside that tube," Tassone says.
Smith says he closely monitors any patient who does get pregnant, to ensure the fetus is implanted in the right spot. For now, women who pay cash in hope of getting pregnant again must hope Smith's right in his belief he's getting help from above. "I try to represent what Christ has done for me. I try to do that for the patient, and I think by keeping that in focus, that my hands are guided by God," he says. "So I think I have gifted hands and I think that's part of the reason that these reversals have worked."
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Dylan Hollingsworth
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Maria Rocha stopped by Dr. Smith's office for a consultation, considering the Essure reversal after suffering effects — mainly a huge, bloated belly, bleeding and fatigue — she says the device caused. She also contemplated having children with her fiancé, whom she wasn't with when she got the device two and a half years before. Smith warned her that if she got pregnant, the baby could die unless she underwent a C-section, so she ultimately decided against the surgery.
Rocha was receiving Medicaid benefits when she had the Essure implanted in 2012 and was told by her doctor at a low-income clinic in Waco that he no longer performed tubal ligation. On the day her device was placed, a representative from Conceptus coached her doctor on what to do, she says.
Rocha remembers being surprised by the pain. Later, she ran into a nurse from the clinic, she says, who told Rocha she was one of the first patients her doctor implanted. (His office didn't return messages). She lived with the pain for two and a half years, searching for doctors to help her, until this spring, when, after deciding against the surgery with Smith, she got a hysterectomy from the same doctor who installed the Essure. But he still denies that her health problems are caused by Essure, Rocha says. "He doesn't have an explanation, like why I'm in pain all the time, bloating, why I have periods like twice a month sometimes," Rocha said. Her surgery is in August.
Essure is popular with insurance providers — Medicaid covered about 6,000 Essure procedures in Texas over the last three years, according to data from the Texas Health and Human Services Commission. The ease of getting the procedure can make the patients feel suddenly stranded when they can't get coverage for subsequent complications.
Casey Kummell, an office manager in South Lake, had her Essure procedure in April last year in the same Irving clinic where she gave birth to her children. Kummell was on Medicaid at the time while her husband was unemployed. She wanted to get her tubes tied, but her longtime doctor told her Essure was the better choice.
Kummell read about the backlash to the procedure online and saw that famed but controversial environmental activist Erin Brockovich had started a website against Essure after women in the Facebook group flooded her with mail in a letter-writing campaign. "He said, you know, what a joke all that was, the whole Erin Brockovich stuff, that it's all a joke, all of that can't be caused by this little device," she says, "and so I trusted him."
The procedure was quick and easy, but she developed cramping soon after, a strange pain that felt like being poked with a hot stick. A scan taken by her doctor, which she provided to the Observer, showed that one of the Essure coils had migrated out of her fallopian tube and into her uterus. Her doctor told her he would perform surgery on her for no charge to get the coil out, she says, but the hospital would still charge her $30,000. No longer on Medicaid, she couldn't afford the procedure.
She developed heavy anxiety, fearing she'd need to get a hysterectomy. Finally, nearly a year later, Kummell was able to get on her husband's insurance after he got a new job. The same doctor who installed the Essure performed a complicated surgery to get it out, slicing off a portion of Kummell's uterus but sparing her a hysterectomy. She believes her doctor was genuine when he told her he had never had complications with Essure before.
A pattern of doctors disbelieving patients who complained of side effects began early, back in the clinical trial phase, women say. The Observer interviewed five women who were in post- and pre-market studies of Essure who say they later underwent invasive surgery to get their organs removed. Two provided medical records from their clinical trials.
"We were told it had been passed in the U.S.A. and was new to England. We were in a trial to see if we could get on with our daily lives immediately after," writes Lisa Bennett, a woman in Leeds who says she was part of a clinical trial in 2000, two years before Essure was approved for sale in the United States. Soon afterward, she was in pain and asked for a hysterectomy. Doctors performed the hysterectomy after she demanded it, she writes, but still insisted her pain wasn't caused by the device. Her doctor "was adamant it wasn't Essure related," Bennett says in a message.
The U.S. Food and Drug Administration approved Essure under stringent guidelines called the Class III Premarket Approval process, which is supposed to be so strict that the manufacturers of the device are protected from lawsuits. One attorney in Florida is trying to start a class-action suit anyway. In a petition to the FDA several months ago, his firm includes the medical records of Kim Hudak, one of the clinical trial participants. Several questionnaires in her file show that doctors crossed out answers to her questions and circled new answers. In an interview, Hudak said she recalls filling out the forms herself but with heavy coaching from nurses and researchers, who told her she wasn't suffering any adverse events despite her failing health. Other questionnaires were done over the phone. "I have continued to see doctors of various specialties since 2006, but no one seems to know what is wrong with me," Hudak wrote to her research doctor, Dr. Linda Bradley at the Cleveland Clinic in 2013.
In 2008, eight years after her participation in the trial began, Hudak asked Dr. Bradley for guidance. She was undergoing a removal of one of her ovaries to treat "excessive endometrial growth." She wanted to make sure the surgery was safe to do with the Essure inserts. Bradley counseled Hudak on the phone, she says, and told her to go ahead with surgery.
Shortly after, Hudak received a letter from Cleveland Clinic's Cheryl Williams, clearly indicating the company was no longer interested in hearing from Hudak. "The sponsor has decided to discontinue the study as of December 31, 2008," the letter said. "This means you will not receive any future phone calls or be asked to come in for office visits related to this study." (The Cleveland Clinic says through a media representative: "Our records indicate that the patient voluntarily and actively participated in the STOP-2000 clinical trial from 2000-2008, and both the Cleveland Clinic and the patient complied and completed all study requirements until the study was discontinued by Conceptus in 2008. At that time and with consent, the collected data was submitted to Conceptus for interpretation. Documentation of the patient is consistent with device studies, and the information recorded was provided by the patient.") More recently, Hudak underwent a full hysterectomy.
Dr. Zampaglione, from Bayer, says he reviewed Hudak's records and found nothing wrong. "There were some cross-outs, but those do occur in any kind of medical record, mistakes are made ... what was done was a cross-out and initialing, a cross-out that is 100 percent absolutely allowable and by the book," he says.
Hudak isn't the only participant who believes medical records misrepresented her experience. "A lot of the documents I have were not filled out by me," says Patricia Rhodes, who agreed to join a clinical trial for a free, permanent birth control method in 2000, at the urging of her now ex-husband. She was 24, with one daughter. A security guard then, she had no health insurance, and her then-husband no longer wanted to pay for her hormonal birth control shots. He heard an ad for the clinical trial on the radio. "He's like, 'Hmm ... permanent and free, go check it out,'" Rhodes says.
Rhodes knew she was allergic to nickel, she says, but the doctors told her the coils contained only stainless steel. (The clinic did not return messages seeking comment.)
"I asked them, I don't know, six or seven times, what they were made out of, because I have metal allergies. After six or seven times of bugging the crap out of them trying to find out what [the Essure coils] were made out of, they just told me, 'Oh, they're 100 percent surgical stainless steel,'" Rhodes says. Her clinical trial paperwork similarly shows no mention of any nickel. Essure pamphlets now explicitly warn: "Patients who are allergic to nickel may have an allergic reaction to the inserts."
Her medical consent forms also show no written warnings that the device contained nickel. Zampaglione, the Bayer doctor, said the forms omitted any mention of nickel because patients with nickel allergies were automatically excluded from participation. "If a woman had a nickel allergy, she would have never even made it in the study to sign a consent form, so that is probably why the consent forms for the very early studies did not have anything about nickel."
Yet during the FDA's meeting in 2002 to approve Essure, representatives from Conceptus told an FDA panelist that nickel coils were safe even for women with nickel allergies. "There was no evidence of local toxicity or local irritancy used with the Essure devices," the representative said to an FDA panelist who asked about nickel allergies. Firmalino, the founder of Essure Problems, obtained footage of the meeting by organizing a fundraiser through Essure Problems and purchasing the copyright from the video company that produced it.
Rhodes says her complications began immediately. She bled for the next six months, felt constant pain in her pelvis and developed urinary tract infections.
"Six months after I got them, I was diagnosed with a hormone imbalance, which I didn't have prior," she says. The clinical trial documents make no reference to any of her ailments. On patient questionnaires from the trial, which Rhodes recently obtained, she is listed as feeling "very satisfied." At the same time, her medical records indicate that over the years she made multiple "unscheduled visits" to the doctor's office for pain in her abdomen. Her health continued to deteriorate, she says. She developed ovarian cysts and new allergies to certain foods and medications. By her late 30s, she says, she felt as though she was going to die. A doctor diagnosed her with porphyria, a rare blood disease.
The investigating doctors studying her told her the problems couldn't be related to the device, Rhodes says. In 2002, another doctor prescribed her 14 different medications to manage the symptoms in her uterus and stomach, her medical records show. That same year, Rhodes' clinical trial documents claim that she found her "comfort wearing the device" to be "excellent." Years later, another woman in the same trial, at that same clinic in Arizona Rhodes visited, would give an interview on a local news station making a similar claim: Her clinical trial questionnaires were wrong — they grossly underestimated how much pain she was in. Rhodes finally found a doctor to perform a hysterectomy in March of this year.
In late June, an FDA representative gave Hudak a surprise call. The agency wanted to invite her personally to attend a public meeting planned about Essure, coming up this September. That same day, on June 25, the agency posted a new, public statement about Essure. People have sent more than 5,093 complaints about the device to the agency's adverse-events database, including reports of pain, fatigue, weight gain, heavy periods and nickel allergies. Worse were four reports of adult women who died, and five reports of fetal deaths. The FDA's announcement came several months after a study from Yale found Essure comes with a 9.6 percent failure rate for women trying to avoid pregnancy — previously, all methods of sterilization for both men and women were thought to have a failure rate of less than 1 percent and Conceptus claimed Essure was over 99 percent effective.
Bayer argues that the adverse events and pregnancies are still low enough for the benefit to outweigh the risk. About 750,000 women have been implanted with Essure, according to figures provided by the company and based on the number of kits sold.
Tassone, the doctor in Austin, recalls implanting Essure in a woman in 2006 and watching her tube spasm without warning. The coil suddenly disappeared inside her body. The sales rep in the room, he says, told him to go ahead and put another coil in. Tassone says he refused, thinking that didn't seem like sound medical device. He monitored the woman, he says, and as far as he knew, she never had side effects.
Now, women will occasionally post to the Essure Problems group post-surgery photos of multiple coils that were retrieved from each tube, rather than the one per tube supposed to be there. "I think I've seen up to five," Tassone says. Zampaglione said he could not comment on Tassone's story but said in some women, it is OK to use more than one coil per tube.
In recent years, Tassone says he has performed about 20 surgeries on women who want the Essure removed. He describes patients with huge, distended bellies that suddenly disappeared after the surgery. Other women have told him they experienced more subtle relief from the removal: more energy, better moods and a clearer mind. Perhaps some of the improvements are a placebo effect, he acknowledges. But he doesn't think that should matter. "The point is, if they say they feel better ... who am I to say that the reason that they feel better is good or bad?"
Email the author at amy.silverstein@dallasobserver.com Twitter @AmySilstein
http://www.dallasobserver.com/news/a-device-promising-safe-permanent-birth-control-delivers-pain-women-say-7419165
Thursday, April 23, 2015
Stop Military and Civilian Medical Error 'Death Without Disclosure': Petition
Please sign this petition! Disclosure: Death from Medical Errors
WE PETITION THE OBAMA ADMINISTRATION TO:
Mandate Reporting of All Medical Errors to an Independent Oversight Committee, and to the Patient or Their Next of Kin.
We call on President Obama to mandate a national 'Medical Error Transparency Plan'. Medical errors are known to be the third leading cause of death, and medical errors also create a high number of disabilities. Patient's human rights are being violated by the current lack of transparency. We call for mandatory reporting of medical errors by anyone that has knowledge of, or reasonably suspects, that a medical error has occurred. Reporting must be to an independent oversight committee as well as to the patient, or to the deceased / incapacitated patient's healthcare representative.
Background story:
Service Members Are Left in Dark on Health Errors
By SHARON LaFRANIERE APRIL 19, 2015
FORT WAYNE, Ind. — Lt. Col. Chad Gallagher was T. J. Moore’s squadron leader when the 19-year-old recruit arrived for basic training last spring at Lackland Air Force Base in San Antonio. He was watching at the quarter-mile track nine days later when Mr. Moore, on an easy mile-and-a-half test run, collapsed at the finish line and was rushed to a hospital.
And he was in Indiana shortly afterward to deliver a sorrowful eulogy at Mr. Moore’s funeral. “He had tears in his eyes,” Mr. Moore’s mother, Anita Holmes, said in an interview at her home here. “He said, ‘I didn’t do enough to protect T. J.’ ”
A year later, Ms. Holmes says she still does not know what Colonel Gallagher meant by that.
Outside experts who reviewed her son’s medical records at the request of The New York Times identified a serious medical error at the Lackland clinic: a decision to allow Mr. Moore to make the run even though doctors had pulled him from normal training after he failed the same test just days before. Test results revealing a genetic condition that in rare cases can lead to sudden death during physical exertion were apparently overlooked.
But the official Air Force explanation — in a 15-page report in a white binder, delivered to Ms. Holmes in December after months of inquiries — was that the military had followed proper protocol. No mistakes were identified. No one was faulted.
“I raised T. J. as a single mother on little income for 19 years, and kept him safe. They had him for nine days and sent him home to me in a box,” said Ms. Holmes, who called the report “garbage.”
“No one,” she added, “has really given me good answers about why.”
Tens of thousands of serious medical mistakes happen every year at American hospitals and clinics. While a handful of health care organizations have opted for broad disclosure amid calls for greater openness, most patients and their families still face significant obstacles if they try to find out what went wrong. But as Mr. Moore’s case illustrates, the nation’s 1.3 million active-duty service members are in a special bind, virtually powerless to hold accountable the health care system that treats them.
They are captives of the military medical system, unable, without specific approval, to get care elsewhere if they fear theirs is substandard or dangerous. Yet if they are harmed or die, they or their survivors have no legal right to challenge their care, and seek answers, by filing malpractice suits.
Only 18 months ago did the Pentagon explicitly allow them to file complaints about their treatment, although some had done so earlier. But even then they are barred from learning the results of any inquiry. Under federal law, investigations at military hospitals and clinics are confidential, in part to keep the findings from the roughly two million civilian patients they treat per year — spouses and children of service members, retirees and others — who can and do file malpractice claims.
In scores of interviews, active-duty patients, relatives and military medical workers described how, in that information vacuum, attempts to ferret out the truth about suspected medical mistakes — through freedom-of-information requests, complaints, meetings with military medical officials — produced anodyne letters of condolence, blanket denials of poor care or simply nothing at all.
“There is just no transparency. You can’t sue. You have no insight into the process,” said Cheryl Garner, a military intelligence officer who retired last year. “As active duty, we just don’t have much recourse.”
What’s more, until 2009, clinicians found to have delivered substandard care to active-duty patients in most cases were not reported to a national database that tracks problem medical workers; instead they were reported to an internal database. Even now, those clinicians, typically doctors, are mainly reported only if the service member is disabled or dies, a higher bar than in cases involving civilians.
And comparatively few have been reported, to either database, Pentagon records show. The Army, which runs the bulk of the system’s hospitals, treats four civilian inpatients for every active-duty one. But from 2003 to 2013, it reported nearly 50 times as many medical workers for breaching the standard of care in cases involving civilians.
The experiences of active-duty patients point to broader questions of accountability in a system of 54 hospitals and hundreds of clinics that has recently come under intense scrutiny. As The Times has reported, military hospitals often fail to conduct safety investigations that the Defense Department mandates when patients suffer serious harm or die. Many medical workers report reprisals for speaking out about problems with care. And systemwide efforts to limit errors and bolster quality have often foundered in a convoluted bureaucracy.
Amid growing fiscal pressures, the Defense Department has ordered improvements and is pushing to close hospitals where surgeons and other specialists treat too few patients to keep skills honed. In a new report to President Obama and Congress, a blue-ribbon commission argued that the military hospitals are wrongly modeled after typical civilian hospitals and so are stumbling in their central mission — to train a medical corps for injuries in combat zones.
In an interview, Dr. Jonathan Woodson, the Pentagon’s top health official since 2011, said that the federal confidentiality law notwithstanding, the military explicitly requires its clinicians and facilities to be open and accountable to all patients. If patients and the public once were unnecessarily denied information about quality of care, he said, “that went out the door when I came in.”
“From the top we are fully committed to the standard of transparency,” he said, describing efforts that include retraining thousands of doctors. If that message is not being heeded, he said, “we want to know.”
Yet military culture makes service members the least likely to complain, for fear of being branded troublemakers. And when they have spoken up, some said, they have been brushed aside.
Ms. Garner was 35 in 2007 when she saw a physician assistant at the Langley Air Force Base hospital three times for breast pain and other symptoms she feared might point to cancer. The physician assistant not only dismissed her fears as irrational, she said, but threatened to place a note in her file that could have damaged her career if she came back again.
Nine months later, Ms. Garner was able to switch her care to a Navy hospital. A doctor there speedily ordered a mammogram — and discovered Stage 2 invasive breast cancer. Her persistence, he told her, had saved her life. A double mastectomy and chemotherapy followed.
After she recovered in late 2009, Ms. Garner filed a complaint against the physician assistant, hoping, she said, to protect other patients. But while sympathetic, the hospital’s chief of medical services told her that she had not been mistreated. Not long afterward, the physician assistant was promoted.
‘Drive Families Crazy’
“When it is pretty clear that something occurred, and nobody is being honest with them, that will drive families crazy,” said Dr. Robert Truog, a professor of medical ethics at Harvard Medical School.
To Belinda and Ronald Robinson, that aptly describes the five years they have spent seeking an explanation for what happened to their 27-year-old son, Sgt. Ronald Robinson Jr., at the hospital now called San Antonio Military Medical Center. A gregarious computer technician with a blue Mustang and a love of barbecue, Sergeant Robinson enlisted in the Army at 19, hoping for a long military career like his father’s. But six years later, he was found to have a heart condition called atrial fibrillation, shared by several million Americans and characterized by an abnormal heart rhythm. Exercise sometimes left him disoriented, dizzy, even unable to speak.
Facing a possible lifetime of medication, he decided on an outpatient procedure in which an electrode on a catheter threaded into the heart burns away the problem tissue. Tens of thousands of such procedures are conducted annually in the United States, with an estimated death rate below one in 1,000.
In April 2010, Mrs. Robinson was waiting at the hospital for her son’s procedure to end when a surgeon burst in. “Something went terribly wrong,” he told her. Despite an all-out effort, Sergeant Robinson died within hours.
Two days later, she said, the cardiac electrophysiologist who performed the procedure, Dr. Robert Eckart, telephoned her and her husband. “He said, ‘I wish I could tell you what happened,’ ” Mrs. Robinson recalled in an interview at the family’s restaurant in Slidell, La. “I can never ever forget what he said: ‘It is just an unknown.’ ”
In his notes, Dr. Eckart described the case as an “unexplained rapid death.”
Experts say his caution may have been appropriate. It often takes a thorough inquiry to figure out what happened. But with that one phone call, the Army’s effort to explain Sergeant Robinson’s death came to an end.
Hospital records obtained by The Times suggest the required patient-safety inquiry was never conducted. When the Robinsons asked about the results of an investigation, the Army sent duplicate sets of their son’s medical records. Their Freedom of Information Act requests were answered with a copy of the Army secretary’s condolence letter.
“If we knew the truth, we could deal with what happened,” Mrs. Robinson said. “I could forgive them.”
Two specialists who reviewed Sergeant Robinson’s medical records at The Times’s request called his death both rare and perplexing. But one of them — Dr. Hugh Calkins, director of cardiac arrhythmia services at Johns Hopkins Hospital — said it was not a total mystery. Because of some unknown factor, possibly an equipment malfunction, he said, the doctor inadvertently cauterized too close to two crucial pulmonary veins and the veins shut down, causing fatal hemorrhaging.
“The best people in this field have inadvertently burned inside the veins, and almost always you get away with it,” he said. He called the outcome “a tragic, freak complication,” adding, “I hope that they were straight with the family.”
Told of his comments, Mrs. Robinson fell silent. “No one ever told us that,” she said.
Dr. Eckart, now a civilian physician, said in an email that patient-privacy laws prohibited him from discussing the case. But he wrote, “Sometimes there can be a bad outcome, even if everything was done right.”
Beyond helping bring closure, experts say, honesty about medical errors makes it harder for hospitals to gloss over serious lapses in care.
The San Antonio hospital, the military’s largest, has had a perennial problem with surgical infection control. In 2011, when Mark Probus underwent spinal surgery there, the infection rate of surgical wounds was 77 percent higher than expected, given the mix of cases, according to a Pentagon-ordered comparison with civilian hospitals.
Mr. Probus, then 44, was no average patient: A lieutenant colonel, he worked at Army medical headquarters, assessing hospitals.
But when he nearly died from a surgical infection, requiring three more operations and months of follow-up care, he got no better answers about what had gone wrong than did the Robinsons. When he asked whether the mandatory safety investigation had been conducted, he said, hospital staff members did not respond.
Mr. Probus retired on medical grounds in 2013, utterly disillusioned, he said, by the system’s lack of accountability. “I had no faith whatsoever in what I was doing anymore,” he said.
Honesty With Patients
Defenders of the federal confidentiality law argue that without it, medical workers would not speak freely about mistakes for fear of provoking malpractice suits by the system’s civilian patients. But evidence from some civilian hospitals increasingly raises questions about that argument.
In 2001, the University of Michigan Health System, the state’s largest medical center, decided that officials would inform patients and apologize whenever they discovered a serious preventable error or lapse in care. Administrators say physicians and nurses have grown more open about mistakes — not less — even though, unlike their counterparts in military hospitals, they can be individually sued for malpractice. The hospital has followed its disclosures by negotiating compensation, resulting in lower malpractice costs.
That level of honesty with patients is still rare, but momentum is growing to make it standard. The National Quality Forum, a nonprofit organization whose safety recommendations are followed by hundreds of hospitals, said in 2009 that hospitals should acknowledge and explain preventable errors to patients and apologize.
Dr. Thomas Gallagher, director of the University of Washington’s research center for patient safety and quality of care, said hospital officials can summarize the results of investigations without disclosing so much that medical workers would be afraid to talk. At Johns Hopkins, physicians routinely tell patients not only what inquiries found, but what changes resulted, said Dr. Albert W. Wu, a physician there and a health policy professor.
The Pentagon has taken steps to open up: Three years ago, officials successfully pushed Congress to narrow the 1986 confidentiality law, suspecting it was being used to withhold not only judgments about care but medical facts.
Regulations now require that those facts be shared, thousands of doctors are being retrained and a small band of mediators has been hired to help. The military’s policies, Dr. Woodson says, are no different from those of most civilian hospitals.
Still, in the eyes of leaders in the field, like Richard C. Boothman, the Michigan health system’s clinical safety chief, such policies fall short. “If you can’t be honest about the conclusion, about whether what you did was right or wrong, whether it was reasonable or not reasonable, I don’t see how you can say you have a culture of full disclosure,” he said.
Arguing the need to maintain military discipline, the Defense Department has opposed a series of congressional attempts to modify a law that the Supreme Court ruled in 1950 bars active-duty service members or their survivors from filing malpractice claims. Officials insist that the prohibition in no way lessens the quality or scrutiny of care provided to service members.
But it has led to a bifurcated system of review that has produced proportionally fewer reports of medical workers for substandard care of active-duty patients than of civilian ones.
If the department determines that a medical worker breached medical standards in a civilian case that resulted in a malpractice payment, the worker must be reported to the National Practitioner Data Bank, which health care and licensing organizations routinely check to spot problem physicians and nurses. A similar inquiry is supposed to ensue when the Pentagon authorizes death or disability benefits for an active-duty patient — although until 2009, clinicians who were faulted in those cases were reported only to an internal database.
But in practice, few active-duty cases reach that level of scrutiny. Col. Kimberly Kesling, the Army’s chief of patient safety, said that is because service members are typically young, healthy and in need of only routine care.
Even so, service members make up one-fifth of inpatients and one-fourth of the maternity cases at military hospitals. Yet from 2003 to 2009, the military reported just 15 clinicians for substandard care of active-duty patients, while reporting 710 clinicians — 47 times as many — for unacceptable care of civilian patients leading to a payment.
In interviews, other current and former senior health officials attributed the discrepancy to several factors. For one, analysts who review disability cases typically do not focus on whether bad care is to blame. Indeed, at seven military hospitals visited by inspectors, staff members who handled disability claims did not even know they were expected to look for signs of malpractice, according to a 2007 department report.
“The disability system has never been structured to be a quality-of-care review,” said a senior Air Force official in charge of risk management. “It is fundamentally a disconnect.”
Beyond that, clinicians can be reported for substandard care of a civilian patient who wins a malpractice claim no matter the level of harm — not just if the patient is disabled or dies. Finally, service members are often reluctant to even file disability claims for fear of being declared unfit for duty, making their cases less likely to be investigated.
The gap has narrowed since 2009, when the military tightened regulations and started reporting active-duty cases to the national database. But it has not vanished: In the next four and a half years, 17 times as many medical workers were reported for poor care of civilians than of active-duty patients.
From 2003 to 2013, the Army reported not a single clinician for breaching medical standards in a case that left a service member disabled — despite tens of millions of active-duty patient visits and roughly 250,000 hospitalizations.
‘A Terrible Error’
T. J. Moore enlisted in the Air Force two months after high school, telling his mother that he wanted to accomplish “something big” and help care for her and his sisters. “Now you can rest,” he told her.
A former football player with an engaging grin, he seemed to fit in well at the Air Force base in San Antonio. But on his first Saturday of basic training, he flamed out on the 1.5-mile run, part of a mandatory initial fitness test. Given 18 and a half minutes to run six laps, Mr. Moore stopped after three laps. “Running is not for me,” he declared.
The Times pieced together what followed from Mr. Moore’s medical records, the official Air Force report and records of the family’s meeting with Air Force officials.
Dr. Aasif Mirza, who examined Mr. Moore the next Tuesday at the base’s health clinic, pulled him from standard training. Neither alternative he proposed was viable under military regulations, so the next day, another physician, Dr. Charlie Collenborne, sent Mr. Moore to a medical hold unit for trainees with health issues.
A nurse wrote in his chart: “Pt reports that he can not run at all.” The official Air Force report said “a thorough medical evaluation” was ordered.
Had that occurred, someone most likely would have noticed the results of a blood test that had arrived at the clinic the previous afternoon. Routine lab work done when he arrived at Lackland showed that Mr. Moore had sickle-cell trait, a genetic condition affecting 8 percent of African-Americans.
The vast majority of people with sickle-cell trait lead normal lives, and many are not even aware of their status. But in rare cases, people with the trait who engage in sudden, intense exercise suffer a poorly understood metabolic storm that can end in sudden death. Risk factors include heat and poor physical conditioning.
The military has long worried about such cases: Studies decades ago found that African-American recruits with the trait had a 30 percent higher rate of exercise-related death than those without it. The Air Force screens recruits for the trait and requires precautions, not always enforced: Just three years earlier, a Lackland recruit with sickle-cell trait died after the same 1.5-mile timed run. He had never been issued the required armband to alert medics to his status.
In Mr. Moore’s case, a medical worker had scheduled a Friday appointment to inform him of his test results, sending an email to squadron leaders. But on Thursday, his situation came to a head. Squadron leaders wanted to know if he would repeat the run or should be sent home. A low-level nurse at the base clinic contacted the physicians who had seen him in the previous 48 hours.
Although both had restricted him from basic training, the Air Force report suggests they changed their minds. “Both physicians stated that the Trainee of Concern was medically qualified and simply ‘deconditioned,’ ” it states. It stresses that Mr. Moore himself reported feeling fine since his run five days earlier — the last time he had engaged in any exercise.
The nurse relayed the information to a physician assistant, Seth Kasunick, who cleared Mr. Moore; neither he nor anyone else conducted a physical examination. His note documenting the decision, written after Mr. Moore died, said he had been “informed the trainee was without health concerns.”
That afternoon, in 82-degree heat, Mr. Moore ran five laps quickly. One hundred yards from the finish line, he fell down, got up and collapsed again. He died that night of what the medical examiner later ruled were complications from sickle-cell trait.
Three independent experts who reviewed Mr. Moore’s medical records at The Times’s request agreed that medical workers had failed him. Dr. Janis Abkowitz, a well-known hematologist and medical professor at the University of Washington, said abandoning the precautions just ordered by two physicians “was a terrible error.”
Dr. Stephen Rice, a specialist recommended to The Times by the American College of Sports Medicine, said that based on Mr. Moore’s symptoms when running — especially that his legs felt very hot — physicians should have investigated whether his muscle tissue was breaking down and leaching proteins into the bloodstream. That condition, called rhabdomyolysis, has been associated with sudden death of people with sickle-cell trait who overexert. And the sickle cell test results “should have been communicated to everyone,” he said.
“There was a breakdown here, no question about it,” he said. “You have to gain some lessons here. You can’t just say this is a tragedy.”
The military’s clinicians — Dr. Mirza, Dr. Collenborne and Mr. Kasunick — did not respond to phone calls for comment. Nor did Mr. Moore’s squadron leader, Colonel Gallagher. In a statement late on Friday, the Air Force said that Mr. Moore had died from complications related to a pre-existing condition and that no one who had trained or cared for him was negligent.
Defense Department officials say it is important that patients or relatives hear directly, and promptly, from caregivers in cases of serious harm or death. Surrogates do not work because patients and families do not trust them.
But nine months after her son died, Ms. Holmes said she had only his death certificate, a condolence letter and assurances that inquiries were underway, one of which ultimately produced a report not covered by the confidentiality law. “How can you fight back when they won’t talk to you?” she asked then.
The four Air Force officers who arrived at her house the next month with that report were just messengers, with no ties to the recruit. Their message was that medical workers had come to a careful, deliberate consensus that he could safely repeat the test run. They did not address why the “thorough medical evaluation” described in the report had not been conducted. Nor did they say whether anyone had considered the sickle-cell test results.
Ms. Holmes told the officers that their remarks were scripted. “The people who were in contact with him should have been the ones who came here today,” she said. “It would make me feel so much better if they would just say, ‘We messed up,’ ” she said after reading the report they gave her on their way out. “I just want them to own up and say it, not put up some kind of front.”
In frustration, she wrote to Colonel Gallagher, the squadron leader who said at the funeral that he had not done enough to protect her son. She wanted to ask him directly what he had meant.
There was no reply.
Andrew W. Lehren contributed reporting from New York.
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