"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."

Make YOUR thoughts known now! Bayer Essure BLACK BOX warning is not enough!

This is the link:

http://www.regulations.gov/#!submitComment;D=FDA-2016-D-0435-0001

The Food and Drug Administration (FDA) Notice: Labeling for Permanent Hysteroscopically-Placed Tubal Implants Intended for Sterilization, Draft Guidance for Industry and Food and Drug Administration Staff; Availability

My information is public and I chose 'Individual Consumer'

"In 2010, the FDA paid to fly me to Silver Spring MD for three days of training to be a CDRH (medical device) Patient Representative.  I have never been called to serve on an Advisory Panel because nearly 100% of all medical devices go through the 510(k) -aka 510 pray- clearance method.  The device manufacturer names a predicate device, submits a fee and some paperwork and the clearance is approved.  Bayer Essure coils are rare in that they were cleared through PMA which protects the manufacturer from any litigation.   The women harmed by Bayer Essure are truly sacrificial lambs.  They were not informed that there is absolutely no warranty on this product and that their basic civil rights to a jury trial are null and void.  The harm perpetrated by this German conglomerate is assured by the current proposed legislation.  The PMA should be immediately revoked so that patient rights to justice are restored.  If Bayer conducted a legitimate scientific study and the product performs (patient outcomes) as advertised, this will come out in ‘discovery’.  In any case, there should not be any more insertion of these coils until the safety and effectiveness of this device are determined.  The leadership of the CDRH is questionable, at best.  Dr. Jeffrey Shuren’s entire household income is dependent upon the medical device industry(his wife, Allison is the partner at Arnold and Porter, LLP and prepares companies for device clearance).  Dr. William Maisel was arrested and convicted of soliciting a prostitute, yet he maintains his employment and is instrumental in clearing devices for women’s pelvic health (he is a cardiologist!).  This legislation is far too little and far too late. " 

Joleen Chambers Comment Tracking Number: 1k0-8ofc-rm8e

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.

* Dr. William Maisel (william.maisel@fda.hhs.gov) was convicted of soliciting a prostitute.   

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

Call for Resignations of FDA/CDRH Directors Shuren and Maisel

Jeffrey Shuren, FDA/CDRH Director

Allison Shuren, wife of FDA/CDRH Director

William Maisel, FDA/CDRH Deputy Director

PREVENTABLE Patient Harm from lax FDA/CDRH regulation

Metal-on-metal hips  500,000

Pelvic Surgical mesh 70,000

Bayer Essure 20,000

Power Morcellator for pelvic surgeries

Duodenoscope infections

Bard 'Recovery' Blood Clot Filter fatalities

FDA has a 'hearing problem'. Harmed patients (women) amplify social media voice!

FDA Reviews Essure to See if Device Causes Problems by REUTERS  9/23, 2015

U.S. health experts will review the potential risks of Bayer AG's permanent contraceptive device, Essure, on Thursday in light of growing complaints over possible side effects, and consider whether its use should be restricted. Some 17,000 women who had the device implanted and claim it has hurt them are members of the Facebook group "Essure Problems," run by Angela Lynch, who herself experienced problems with Essure. Complaints voiced by the women include chronic pain, heavy bleeding, fatigue and skin allergies. The Food and Drug Administration panel will be asked to discuss potential changes to the product's label and whether further clinical studies should be conducted. The panel will not be asked to formally vote on their recommendations. Bayer obtained the device with its $1.1 billion acquisition of Conceptus in 2013 and maintains it is safe and effective. It says roughly 750,000 units have been sold, mostly in the United States. It's a small metal spring that goes into the fallopian tubes - an alternative to tying them. Dr. Patricia Carney, the company's medical director for Essure, said the company welcomes the discussion. "We want to understand as a company what is going on," she said. "We want to know whether there is a link to the product." Already the complaints have led some physicians to re-examine their use of the device. Dr. Sebastiaan Veersema, a gynecologist at St. Antonius Hospital Nieuwegein in the Netherlands, was an early European adopter, implanting the device in nearly 1,400 women and training dozens of practitioners in its use. He now believes more research needs to be done to establish what, if any, relationship exists between the device and the problems relayed by some patients. "If there is something wrong with the device I want to know," he said. Veersema said a stronger screening process might be warranted to avoid implanting Essure in women who already have a uterine problem, such as fibroids. Angela Lynch was 28 when she was implanted with the device. She had three children and did not want any more. "Because I had just had a kid I wrote off all my symptoms as hormonal, my body trying to adjust," she said. "After two years I started losing hair. Then I started losing teeth, and over time it got to where my whole body was hurting." In 2012 she had the device removed and underwent a hysterectomy. "After three days it was like I woke up from a five-year flu," she said. Dr. Cindy Basinski, who consults for Bayer and will be testifying on the company's behalf at the FDA meeting, has been implanting the device since 2006 and has conducted about 1,100 procedures with minimal complications. She has had "a couple" of patients come to her with complaints and one asked for the device to be removed. Basinski, who practices in Newburgh, Indiana, said she in "no way discounts the patients out there recounting their experience," but said it was not possible to draw scientific conclusions from anecdotal information. For some doctors, it is not just the implantation of the device that needs to be looked at but how it is removed. Dr. Shawn Tassone, who practices at a clinic in Austin, Texas, began implanting Essure in 2008, said there is no standardized method for removal. "I'm hoping that all this will change the way doctors counsel their patients," Tassone said. "Instead of saying Essure is an easy procedure with no side effects, (they should) say this is a surgery and there are people reporting complications."

http://www.nbcnews.com/health/womens-health/fda-reviews-essure-see-if-device-causes-problems-n432351

Public Citizen blasts FDA for weak regulation of implanted surgical mesh.

FDA Wants High-Risk Label forTransvaginal Mesh

Published: Apr 29, 2014

By Charles Bankhead, Staff Writer, MedPage Today, 

Public Health & Policy

FiDA highlight

WASHINGTON -- The FDA has proposed reclassification of surgical mesh for transvaginal repair of pelvic organ prolapse (POP) as a "high-risk device," a designation that mandates an FDA review of safety and effectiveness prior to considering approval.

The agency also wants to reclassify certain instruments used to perform POP repair as "intermediate-risk devices," as opposed to the current low-risk designation.

"The FDA has identified clear risks associated with surgical mesh for the transvaginal repair of pelvic organ prolapse and is now proposing to address those risks for more safe and effective products," William Maisel, MD, of the FDA's Center for Devices and Radiological Health, said in a statement. "If these proposals are finalized, we will require manufacturers to provide premarket clinical data to demonstrate a reasonable assurance of safety and effectiveness for surgical mesh used to treat transvaginal POP repair."

The proposal does not affect surgical mesh used to treat stress urinary incontinence (SUI), abdominal POP repair, hernia repair, and other nonurogynecologic indications. The proposal is subject to a 90-day public-comment period prior to a final decision.

The proposed reclassification follows other FDA actions and statements related to transvaginal POP repair materials going back 6 years:

         October 2008 -- Released a Public Health Notification about serious complications associated with transvaginal placement of surgical mesh for POP and SUI

         July 2011 -- Released an updated safety communication about serious complications associated with transvaginal POP repair with surgical mesh

         July 2011 -- Released a review of urogynecologic surgical mesh adverse events and scientific literature, identifying serious safety and effectiveness concerns

         September 2011 -- FDA's Obstetrics and Gynecology Devices Panel recommended reclassification of surgical mesh for transvaginal POP repair from class II to class III and require premarket approval

         January 2012 -- FDA ordered manufacturers to conduct postmarket surveillance studies to address specific safety and effectiveness concerns about surgical mesh used for transvaginal POP repair

Some materials to repair POP come as kits that include the mesh and instruments used to place, attach, and secure the mesh. Instruments also are sold separately from the mesh, and the FDA proposal to reclassify instruments pertains to the instruments that are not included in kits.

The FDA action represents a case of "too little, too late," according to Michael Carome, director of Public Citizen's Health Research Group, a Washington-based public health advocacy group. Public Citizen has petitioned the FDA to recall all surgical mesh products from the market.

"Today's action comes nearly 3 years after our petition and after an FDA advisory committee recommended such action," Carome said in a statement. "Moreover, the proposed timeline for full implementation of the FDA's order, if finalized, will take several more years.

"As a result of the FDA's reckless delays and inadequate action regarding surgical mesh for transvaginal POP repair, thousands of women will continue to be unnecessarily exposed to a wide array of serious risks, many of which can permanently alter women's quality of life."

Surgical Mesh: High-Risk Device via FDA

FDA NEWS RELEASE

FDA issues proposals to address risks associated with surgical mesh for transvaginal repair of pelvic organ prolapse

The U.S. Food and Drug Administration today issued two proposed orders to address the health risks associated with surgical mesh used for transvaginal repair of pelvic organ prolapse (POP). If finalized, the orders would reclassify surgical mesh for transvaginal POP from a moderate-risk device (class II) to a high-risk device (class III) and require manufacturers to submit a premarket approval (PMA) application for the agency to evaluate safety and effectiveness.

POP occurs when the internal structures that support the pelvic organs such as the bladder, uterus and bowel, become so weak, stretched, or broken that the organs drop from their normal position and bulge (prolapse) into the vagina. While not a life-threatening condition, women with POP often experience pelvic discomfort, disruption of their sexual, urinary, and defecatory functions, and an overall reduction in their quality of life.

“The FDA has identified clear risks associated with surgical mesh for the transvaginal repair of pelvic organ prolapse and is now proposing to address those risks for more safe and effective products,” said William Maisel, M.D., M.P.H., deputy director of science and chief scientist at the FDA’s Center for Devices and Radiological Health. “If these proposals are finalized, we will require manufacturers to provide premarket clinical data to demonstrate a reasonable assurance of safety and effectiveness for surgical mesh used to treat transvaginal POP repair.” 

Surgical mesh is a medical device that is used to provide additional support when repairing weakened or damaged tissue. Many mesh products come in kits that include instruments specifically designed to aid in insertion, placement, fixation, and anchoring of mesh in the body. Instruments provided in kits will be reviewed as part of the regulatory submission for the mesh product. Instruments are also provided separately from the mesh implant, and the FDA is proposing that this urogynecologic surgical instrumentation be reclassified from low-risk devices (class I) to moderate-risk devices (class II).

Beginning in Jan. 2012, the FDA issued orders to manufacturers of urogynecologic surgical mesh devices to conduct postmarket surveillance studies (522 studies) to address specific safety and effectiveness concerns related to surgical mesh used for transvaginal repair of POP.

In Sept. 2011, the FDA’s Obstetrics and Gynecology Devices Panel recommended that surgical mesh for transvaginal POP be reclassified from class II to class III and require PMAs.

In July 2011, the FDA provided an updated safety communication about serious complications associated with transvaginal placement of surgical mesh used to treat POP. At that time, the FDA also released a review of urogynecologic surgical mesh adverse events and peer-reviewed scientific literature that identified serious safety and effectiveness concerns. The FDA previously communicated about serious complications associated with transvaginal placement of surgical mesh to treat POP and stress urinary incontinence (SUI) in an Oct. 2008 FDA Public Health Notification.

Surgical mesh indicated for surgical treatments of SUI, abdominal POP repair with mesh, hernia repair, and other non-urogynecologic indications are not part of this proposed order.

The FDA will take comments on the proposed order for 90 days.

For more information:

•               FDA Medical Devices

•               FDA: Proposed Order - “Reclassification of Surgical Mesh for Transvaginal Pelvic Organ Prolapse Repair and Surgical Instrumentation for Urogynecologic Surgical Mesh Procedures; Designation of Special Controls for Urogynecologic Surgical Mesh Instrumentation” 

•               FDA: Proposed Order - “Premarket Approval for Surgical Mesh for Transvaginal Pelvic Organ Prolapse Repair”

•               FDA: Urogynecologic Surgical Mesh Implants

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.

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For Immediate Release: April 29, 2014  
Media Inquiries: Susan Laine, 301-796-5349, susan.laine@fda.hhs.gov 
Consumer Inquiries: 888-INFO-FDA, DICE@fda.hhs.gov

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Consumer App for Reporting Adverse Events to FDA!

Reporting Adverse Events? There's an App for That, But Not for Industry--Yet

Latest News | Posted: 24 April 2013

Need to report an adverse event related to a medical device? Now patients are about to find there's an app for that, US regulators revealed yesterday.   https://medwatcher.org

Background

The US Food and Drug Administration (FDA) takes in an enormous number of adverse event reports each year through various systems, including MedWatch.

One issue, however, is that manufacturers, healthcare providers and patients are held to different standards. Medical device manufacturers, for example, are held to medical device reporting regulations that require them to report to MedWatch any adverse events they are made aware of, including for off-label uses.

Patients and healthcare providers, meanwhile, are able to report adverse events, but are not required to do so.

That difference has led to significant under-reporting of adverse events according to some estimates, posing a challenge for regulators in their attempts to transition more of the regulatory assessment process to postmarket settings. If, for example, a particularly dangerous adverse event is only seen in one out of every 10,000 patients, it might not be picked up by clinical testing. Once on the market, lax adverse event reporting practices by healthcare providers could delay the time at which the company and regulators become aware of that safety issue, potentially putting more consumers at risk for a dangerous event.

A New App

That's where FDA's new MedWatcher adverse event reporting application (iOS version) (Android version) comes in, said Bill Maisel, deputy director for science and the chief scientist at FDA's Center for Devices and Radiological Health (CDRH), in a statement.

"This app allows medical device users to easily report suspected or known problems with a device from their smartphone or tablet," he said. Users in this context include patients, caregivers, and healthcare professionals, FDA explained.

Maisel later said in an interview with the Wall Street Journal that the crux of the issue for FDA was: "How can we all find out earlier than we have been finding out?"

"We'll get access to better data more quickly now," he hypothesized.

The audience the application is not to be used by is worth noting in this context: Medical device manufacturers and healthcare providers. Maisel said that these two groups, "will continue to be required to report problems through the Medical Devices Reporting System and the Medical Product Safety Network."

Indicative of Future Changes?

But as Jeffery Shuren, director of CDRH, said at the Medical Device Manufacturers Association's (MDMA) annual meeting in April 2012, the system could be a harbinger of changes to come for industry.

According to MD+DI's Arundhati Parmar, Shuren said that the MedWatcher app "will push through adverse events into the database that will replace the Manufacturer and User Facility Device Experience (MAUDE) database. “It would make it easier for aggregating adverse event reporting.”

That functionality could eventually lead to device manufacturers being given the same reporting capabilities as consumers—an outcome that seems all the more likely given that the MedWatcher app is basically just a more user-friendly version of FDA's Form 3500, according to FDA.

"We're transforming this network into a modern system that uses electronic health information," William Maisel confirmed in an interview with the Wall Street Journal.

But the idea of an app hasn't received unanimous support. Paul Ivsin, a consulting director for clinical trials, argued last week that FDA would be better served by avoiding the use of apps entirely, and instead focus on "developing a robust set of Application Programming Interfaces (APIs) that can be used by the teams who are developing medical data apps." That would result in a wider array of more customizable options to meet the needs of hospitals, manufacturers and patients, he argued. In addition, they could link up with other databases, such as the Sentinel Initiative, giving users access to more information. That would also be in line with a 2012 White House directive ordering agencies to make more data open to the public via APIs.

For now, though, FDA can only wait and see whether consumers actually use the applications. As of the time of this article's publication, the app has been downloaded more than 10,000 times.