FDA Violations and Highest Risk FDA Bayer Essure

Original Essure Manufacturer Had Long History Of FDA Violations

By Michael Monheit    March 10th, 2016

In 2013, German pharmaceutical manufacturer Bayer acquired a small California-based company named Conceptus Inc. As the name suggested, Conceptus’ work in medical devices focused on reproduction, but the company made few waves with its first product line, a system of miniature catheters used to access Fallopian tubes.

It was what Conceptus eventually attached to those micro-catheters that would garner Bayer’s interest, and ultimately convince the multinational conglomerate that Conceptus was worth around $1.1 billion.

“Unanimous Approval” & Growing Profits

Conceptus had developed Essure, a metal coil implant that could be guided through the uterus and inserted into a Fallopian tube. After implantation, the body naturally reacts to the device, or more accurately, the polyethylene terephthalate (PET) fibers wound around the device’s nickel titanium coils. In textile manufacturing, PET is referred to by its more familiar name, polyester. But inside the body, according to Conceptus, PET has a different effect: triggering the growth of scar tissue.* Once the Essure implant has been inserted, the Fallopian tube coats the device in a thick layer of scar tissue, the company says, blocking both the tube itself and any eggs traveling to the uterus.

Essure’s innovative design certainly seemed promising, and Conceptus spent the years between 1998 and 2002 developing and testing the device. After “receiv[ing the] FDA’s most stringent review prior to marketing,” the agency’s so-called Pre-Market Approval process, Essure was approved for sale on November 4, 2002.  Essure was, and continues to be, a Class III medical device, among “the highest risk devices,” according to the FDA.

Few people are aware that the FDA uses two very different processes to regulate medical devices and pharmaceutical drugs. More often than not, medical devices are sent through a fast-track approval process, in which manufacturers need only show that their own device is substantially similar to one already on the market. In practice, though, that “substantial” similarity appears to be loosely interpreted. Many devices make it on the market, and thus into operating rooms and patients’ bodies, without any new safety or effectiveness testing.

But Essure was different, with a radically novel design, one the FDA guessed could cause patient’s significant harm. So the agency required clinical trials involving human subjects. By the time Essure was approved, in 2002, “the FDA had one to two years of safety and effectiveness outcomes data for Essure,” according to Jennifer Rodriguez, an FDA spokesperson who spoke to ABC News in October 2014. A “unanimous approval” followed, with the caveat that Conceptus would continue studying the device’s safety in several required studies.

Essure Soon Marred By Manufacturing & Side Effect Reporting Problems

In the meantime, obstetricians and gynecologists were beginning to adopt Essure as an alternative to tubal ligation, the industry standard for permanent female sterilization. Essure was easier, requiring only a 10-minute outpatient procedure to implant, Conceptus claimed. Citing the results of its clinical trials, which have now been widely critiqued, the coils were “safe and effective.”

Essure was on the ascendant, and Conceptus representatives were busy training doctors around the nation on how best to use the implants. By the end of 2003, according to a company shareholder report available here, “more than 14,000 patients” had been implanted with Essure, and no “pregnancies related to device failure” had been reported. Even more encouraging, Conceptus was turning a profit, reporting $442,000 in gross profits for the 4th quarter of 2003.

But for all the early signs of success, and Conceptus’ growing national reach, problems were beginning to crop up back at home, in Mountain View, California.

Spotty Record-Keeping & Rejected Raw Materials

During a series of routine inspections in June and July of 2003, FDA investigator Mark Chan noticed a discrepancy between Conceptus’ Lot History Records and the information included on Quality Assurance Forms, which track to show that a device is being made in the way its manufacturer said it would be.

Specifically, Chan found “hand-written” notes on the company’s records, which revealed that “raw materials and sub-assemblies (i.e., Inner/Outer Coil Sub-assemblies) were being rejected during” the manufacturing process. But that information wasn’t making its way onto the company’s Quality Assurance Forms, which would have notified Conceptus’ Quality Assurance department of the problem.

In a formal report, known as a Form 483, issued by the FDA when inspectors think they’ve discovered violations of federal law, Chan observed: “not all data […] are analyzed to identify existing and potential causes of nonconforming product and other quality problems.” The inspector also discovered that no “Material Review Reports,” which would have notified an entirely different board within Conceptus of the problem, were being generated either.

Why the materials were rejected in the first place is uncertain, but in Chan’s mind, Conceptus wasn’t checking up on potentially-defective raw materials, and it seemed to be a problem of communication between the company’s departments. In a recent lawsuit, one former Essure patient raised an even more troubling question: where did the rejected raw materials end up? In a trash bin or in an implant?

Conceptus Used Unlicensed Facility For 3 Years, California Health Department Finds

Whatever the answer, observers could not deny the severity of Conceptus’ next run-in with regulatory officials, this time inspectors at the California Department of Health. In 2008, the company was cited for manufacturing Essure implants out of an unlicensed facility.

Conceptus had been using the facility, state Health Department investigators said, for three years. By June 11, 2008, according to a narrative report completed by Health Department Investigator Christine Rodriguez, Conceptus’ licensing violations had been “corrected.” Finally, Conceptus was licensed to manufacture medical devices in California, but the company was far from out of the woods.

FDA Inspector Discovers Unreported Adverse Events

Between December 2010 and January 2011, FDA investigator Timothy Grome reviewed company documents and found evidence that Conceptus had failed to report multiple adverse events to the FDA.

Grome discovered two reports, sent to Conceptus by health professionals between July 12, 2010 and December 10, 2010, of women in whom the Essure implants had perforated their bowels, a complication that could “have caused or contributed to a death or serious injury.” But rather than pass these reports on to the FDA, as the company had with 41 other reports that did not involve bowel perforation during the same period, Conceptus appeared to have kept them internal.

A different report, in which a CT scan had revealed that a patient’s implant “was in 2 pieces […] with one of the pieces outside of the tube between the uterus and bowel,” had also been kept from the FDA, Gromes wrote in a Form 483 that would follow his inspection.

Conceptus’ apparent reporting violations between December 8, 2010 and January 6, 2011 were even more egregious. Gomes found no less than five reports of “perforation,” in which the coil implant had moved into a patient’s abdominal cavity or peritoneal cavity. But none had been submitted to the FDA as required, within 30 days of their receipt.

Gomes hit Conceptus with a related violation, since the coil’s obvious ability to move into the peritoneal cavity had never been included in the company’s official analysis of potential device failures.

Conceptus Denies Device Failure

After Gomes’ visit, the California Department of Health returned to Conceptus’ manufacturing facility for a routine inspection required by state law. While no new violations would be issued at this time, the Health Department’s subsequent report sheds light on the company’s response to the FDA’s findings.

In a letter sent to the federal agency on January 20, 2011, state health investigator Lana Widman wrote, Conceptus “disput[ed] the validity of [Gomes’] observations, regarding the reporting of complaints for peritoneal perforation.” According to Conceptus, the perforations were “a result of the physician’s misuse of the device or an error during insertion and not a failure of the device to perform as intended.”

Today, the FDA is busy drafting a new “black box” warning for Essure. While the final wording of this warning has not yet been published, it is likely to include “fallopian tube or uterine perforation,” alongside side effects like “persistent pain, irregular vaginal bleeding,” and the complication Conceptus failed to report nearly 6 years, “intra-peritoneal device migration.”

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

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

Bayer Essure: A Device of Torture with No Remedy

A DEVICE PROMISING SAFE, PERMANENT BIRTH CONTROL DELIVERS PAIN, WOMEN SAY

BY AMY SILVERSTEIN   Dallas Observer     WEDNESDAY, JULY 22, 2015

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.

Dylan Hollingsworth

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."

Dylan Hollingsworth

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

FAILED Hip Implants prompt FDA study.

 New FDA Study to Look atCauses of Failure in Hip Implants

Posted: 25 July 2013

By Alexander Gaffney, RF News Editor  FiDA Highlight

One of the largest medical device scandals in the last decade has involved

metal-on-metal hip implants, so-named because of the metal (usually chromium)

attachment that attaches a leg to a metal socket.

In the wake of their failures, the US Food and Drug Administration (FDA) moved to examine its regulatory processes, eventually deciding to require premarket approval (PMA) applications for all such implants. But now evidence has emerged that the agency still has further questions about what more it could have done to prevent the devices from ever having reached the market.

Background

Medical devices are a relatively recent addition to FDA's regulatory authority, with FDA only receiving the authority to vigorously regulate them in 1976 under the Medical Device Amendments. Because some medical devices were already marketed at that time, FDA classified them all as class III, high-risk medical devices until it could review and classify them properly.

Some of those devices went on to serve as predicates for 510(k) premarket notification applications, which claimed that they were substantially equivalent to already-approved devices and were thus able to avoid conducting clinical trials to re-prove their safety and efficacy.

The problem with that, some researchers claim, is that many of the original devices which metal-on-metal hips claimed to be ancestors of have since been recalled from the market under dubious circumstances, meaning the devices might never have been safe to begin with. Further, the metal-on-metal hips were not so similar to the original device as to be clearly substantially equivalent. Devices of this sort are routinely approved and are referred to as "split predicates."

In light of those concerns—and a lack of action on the part of Congress during the 2012 passage of the Food and Drug Administration Safety and Innovation Act to explicitly close the so-called loophole—FDA announced on 17 January 2013 that it would move to require all metal-on-metal implant devices to be submitted in the form of a PMA or PDP, which typically require clinical trials in support of the application and thus an investigational device exemption (IDE) application as well.

A New Study

But even with these new requirements, FDA said it is still concerned about hip implants in general, and most especially with respect to how they are worn down. In the case of metal-on-metal hips, the chromium coatings of the device wore each other down, in some cases dislodging metal chromium shavings that caused tissue damage and raised fears about metal ions entering the bloodstream and causing cancer.

In a solicitation notice posted on the Federal Business Opportunities (FBO) website, FDA noted that "there is renewed concern of wear and corrosion of conical head/stem taper junctions in modern modular total hip replacements." While not a "new phenomenon," FDA said new design changes like metal-on-metal bearings, larger femoral heads and modular designs have reintroduced the issue even as the new features more closely approximate patient features.

As a result, FDA said it's embarking on a new project to "investigate the potential link between volumetric wear and corrosion of conical head/stem taper junctions in explanted total hip replacements and clinical outcomes."

As with nearly all solicitation notices, it's looking to the private sector to help it design and run the study, the results of which will be used to "aid development of standard test methodologies for preclinical evaluation of total hip implants."

The study will reportedly look at 250 explanted metal-on-metal hip replacements of various sizes and genders and use the American Society for Testing and Materials (ASTM) protocol for corrosion testing to analyze them. "De-identified patient data and radiographs must be available or obtainable for all devices," the notice explains.

The end goal of the project, which should take about two years total to conduct, is to generate a peer-reviewed journal article explaining correlations between wear and corrosion and relevant parameters (e.g. implantation time, lateral offset, head size, materials, and modularity).

Solicitations are due to FDA by 1 August 2013.

REGULATORY FOCUS Departments: Under RAPS Quality & Compliance Science & Technology Perspective It's the Law

   

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