BAYER Essure sterilization device: FAILED globally.

Bayer to phase out Essure birth control device in U.S.

Tina Bellon

NEW YORK (Reuters) - Life sciences company Bayer AG said on Friday it would discontinue the sale of its birth control product Essure in the United States, citing a decline in sales of the implantable device that made the business no longer sustainable.

The decision followed an announcement by the company in September 2017 that it would discontinue the sale of the contentious sterilization device in all countries outside the United States.

Bayer said in a statement that the decision was not related to safety concerns. The company, based in Leverkusen, Germany, is facing some 16,000 U.S. lawsuits over Essure, and it said it was expecting more.

“The benefit-risk profile of Essure has not changed, and we continue to stand behind the product’s safety and efficacy, which are demonstrated by an extensive body of research,” Bayer said.

It said it had informed the U.S. Food and Drug Administration of its decision and would update healthcare providers.

Essure will be gradually phased out and U.S. sales halted by the end of this year. Doctors will be able to perform Essure procedures until the end of next year when they will be asked to return unused devices.

FDA Commissioner Scott Gottlieb said in a statement that the agency would continue to monitor Essure’s safety, and added, “We expect Bayer to meet its postmarket obligations concerning this device.”

Early in 2016, the FDA put its strongest safety warning label on the device after thousands of complaints and asked the drugmaker to conduct a post-market study.

The agency said it received nearly 12,000 reports in 2017 related to Essure.

Bayer said extensive research by the company and independent medical researchers showed Essure was safe.

Women have claimed in lawsuits that Essure, which is implanted in a woman’s fallopian tubes to permanently block the passage of eggs to the uterus, could pierce the tubes, and that metal parts of the device could become dislodged and migrate to other parts of the body, causing pain, injuries and severe bleeding.

They also claimed that the device failed to prevent unwanted pregnancies and led to nickel allergies and depression.

Bayer has been accused in lawsuits of knowing the risks associated with Essure and failing to warn sellers, doctors and regulators.

Marcus Susen, a Florida-based lawyer representing a number of women who have sued the company, called its decision long overdue, and said it would be up to a jury to decide if Bayer stopped the sale of Essure for commercial or safety reasons.

Bayer spokesman Steven Immergut said the company had sold roughly one million Essure devices worldwide since the product came on the market in 2002.

The majority of those sales were in the United States, he said, where the company has seen an average 40 percent annual sales decline in the device since its introduction.

In April, the FDA said some women were not being properly informed of the risks associated with Essure before getting implanted and it limited its sale to healthcare facilities providing full information about its risks and benefits.

Bayer said in a statement that the decline in sales was due to an overall decrease of permanent contraception in the United States, a growing reliance on other birth control methods and “inaccurate and misleading publicity about the device.”

Reporting by Tina Bellon; Editing by Clive McKeef, Toni Reinhold

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/

Erin Brockovich, Bayer and Essure horror stories

Bayer contraceptives : Sterilization with sideeffects

By Marc Pitzke, Spiegel online/New York

(AFP)  Consumer activist Erin Brockovich: "We seek dialogue with Bayer "

FiDA highlight/Google translation to English from German

 The legendary U.S. consumer activist Erin Brockovich has a new goal - the German Bayer AG. It's about their contraception Essure . Hundreds of women complain of some horrible side effects.

The gynecologist had promised: Everything would proceed entirely " pure and simple ". Two short, outpatient routine interventions , no anesthesia, done. So uncomplicated, the procedure let themselves almost at lunchtime do.

But after the first appointment, Michelle Garcia doubled in "excruciating pain " . After the second, it only got worse : Suddenly the otherwise dynamic woman was constantly tired , then the pain came back , and eventually she began to bleed uncontrollably hard.

"I almost died," the then 38 -year-old recalls. Fast: "I was lucky. "

What Garcia 2011 almost proved fatal, is in fact actually routine. The single mother from Miami did not want any more children and had therefore opted for the Essure procedure, the only permanent method of contraception without surgery. Two blocking coils are placed in the fallopian tube. " A quick, ten minute procedure in your doctor's office," says the manufacturer , Bayer HealthCare , a U.S. subsidiary of Bayer AG in New Jersey.

Been hundreds of horror stories on record

Michelle Garcia, however, is not the only one in the method went wrong. Hundreds of women have now given Essure horror stories on record, on blogs, websites, Twitter and their own Facebook group : chronic fatigue, depression, weight gain , Fibrositissyndrom , degenerative diseases , autoimmune disorders and menstrual disorders, migraine , allergic reactions, rash, dizziness, fever, unwanted pregnancies , miscarriages. Some of the coils are at least partially migrated through the body.

A petition, Essure " to stop or take this product off the market completely ," now contributes nearly 8000 signatures. The protesters also have prominent flank protection: The consumer activist Erin Brockovich - known by the eponymous film, the 2001 Oscar brought Julia Roberts - has done to their side.

"These women have no chance of recourse," Brockovich complains in an interview with SPIEGEL ONLINE . Since its legendary environmental struggle against U.S. power giant PG & E 20 years ago the infamous for their doggedness Ex - paralegal but has become more circumspect. Cooperation instead of war: "We seek dialogue with Bayer. "

But so far, let Bayer rebuffed them. Therefore Garcia and Angela Lynch travel, one of her fellow-sufferers, now to Germany to confront Supervisory Board Chairman Werner Wenning and the Chief Executive Officer Marijn Dekkers at the Bayer Annual General Meeting on Tuesday in Cologne directly. At the invitation of the activist group Coalition against Bayer Dangers Garcia wants to step up to the microphone there.

Bayer, the problem has indeed saddled probably unintentionally, as it bought up the Essure Conceptus manufacturer last year for $ 1.1 billion. "Bayer and Conceptus have the goal with innovations to promote the health of women," rejoiced Andreas Fibig, the CEO of Bayer HealthCare Pharmaceuticals, still there.

"I do not want others to have to join the same "

"Anyone who feels pain or complications, for whatever reason, our great compassion ," said Edio Zampaglione, Vice President of U.S. Medical Affairs at Bayer winds . Bayer debt wear but no: "There is no birth control method that is one hundred percent effective, and which is also clear in our leaflet. "

Derlei " adverse events," said Zampaglione continued, were also " in clinical trials " and a study by the U.S. Pharmacopeia Drug Administration (FDA?) has already been observed and recognized from the beginning. The turn keeps these side effects for infrequent: Essure is " effective as a means of permanent sterilization to 99.83 percent."

Michelle Garcia took their claims to only five months to find out that their pain decreased on Essure. It turned out, therefore, that a coil broken and had wandered in Garcia's abdomen. Both coils should be removed surgically.

Garcia started in a support group to get involved, which now has more than 7,000 members: "I do not want others must join the same." They also sent in 2013 a long letter to Bayer CEO Dekkers, investor relations chief Alexander Rosar and spokeswoman Tricia McKernan . "Women suffer unspeakable pain and serious discomfort, which they got after Essure was implanted," she wrote and warned Bayer. " You now have a nightmare " One answer they never got.

Why are they now pilgrimage to Cologne, " in the lion's den," she says. For their big entrance at Tuesday Garcia has even trained with a coach public speaking because German language was required: " The women rely on my voice. "

Bayer-Verhütungsmittel: Sterilisation mit Nebenwirkungen

Von Marc Pitzke, New York   (Original German)

Die legendäre US-Verbraucheraktivistin Erin Brockovich hat ein neues Ziel - die deutsche Bayer AG. Es geht um deren Verhütungsmittel Essure. Hunderte Frauen klagen über teils grausige Nebenwirkungen.

AFP

Verbraucheraktivistin Erin Brockovich: "Wir suchen den Dialog mit Bayer"

Der Gynäkologe hatte es versprochen: Alles würde ganz "einfach und simpel" verlaufen. Zwei kurze, ambulante Routine-Eingriffe, keine Narkose, fertig. So unkompliziert, die Prozedur lasse sich quasi in der Mittagspause erledigen.

Doch schon nach dem ersten Termin krümmte sich Michelle Garcia unter "qualvollen Schmerzen". Nach dem zweiten wurde es nur noch schlimmer: Auf einmal war die sonst so dynamische Frau dauernd todmüde, dann kamen die Schmerzen zurück, und schließlich begann sie, unkontrollierbar schwer zu bluten.

"Ich wäre fast gestorben", erinnert sich die damals 38-Jährige. Fast: "Ich hatte Glück."

Was Garcia 2011 beinahe zum Verhängnis wurde, ist in der Tat eigentlich Routine. Die alleinstehende Mutter aus Miami wollte keine Kinder mehr und hatte sich deshalb für das Essure-Verfahren entschieden, die einzig dauerhafte Methode der Empfängnisverhütung ohne Operation. Dabei werden zwei Blockade-Spulen in die Eileiter gesetzt. "Eine schnelle, zehnminütige Prozedur in Ihrer Arztpraxis", versichert der Hersteller Bayer HealthCare, eine US-Tochter der Bayer AG in New Jersey.

Hunderte Horrorstorys zu Protokoll gegeben

Michelle Garcia ist aber nicht die Einzige, bei der die Methode schiefging. Hunderte Frauen haben inzwischen Essure-Horrorstorys zu Protokoll gegeben, auf Blogs, Websites, Twitter und in einer eigenen Facebook-Gruppe: chronische Müdigkeit, Depressionen, Gewichtszunahme, Fibrositissyndrom, Degenerationskrankheiten, Autoimmun- und Menstruationsstörungen, Migräne, allergische Reaktionen, Ausschlag, Schwindelgefühle, Fieber, ungewollte Schwangerschaften, Fehlgeburten. Bei einigen seien die Spulen zumindest teilweise durch den Körper gewandert.

Eine Petition, Essure "zu stoppen oder dieses Produkt ganz vom Markt zu nehmen", trägt mittlerweile fast 8000 Unterschriften. Die Protestler haben außerdem prominenten Flankenschutz: Die Verbraucheraktivistin Erin Brockovich - bekannt durch den gleichnamigen Film, der Julia Roberts 2001 einen Oscar brachte - hat sich auf ihre Seite geschlagen.

"Diese Frauen haben keinerlei Aussichten auf Regress", klagt Brockovich im Gespräch mit SPIEGEL ONLINE. Seit ihrem legendären Umweltkampf gegen den US-Stromriesen PG&E vor 20 Jahren ist die für ihre Verbissenheit berüchtigte Ex-Anwaltsgehilfin aber bedächtiger geworden. Kooperation statt Krieg: "Wir suchen den Dialog mit Bayer."

Doch bisher ließ Bayer sie abblitzen. Deshalb reisen Garcia und Angela Lynch, eine ihrer Leidensgenossinnen, jetzt nach Deutschland, um Aufsichtsratschef Werner Wenning und den Vorstandsvorsitzenden Marijn Dekkers bei der Bayer-Hauptversammlung am Dienstag in Köln direkt zu konfrontieren. Auf Einladung der Aktivistengruppe Coordination gegen Bayer-Gefahren will Garcia dort ans Mikrofon treten.

Bayer hat sich das Problem ja auch eher ungewollt aufgehalst, als es den Essure-Hersteller Conceptus im vergangenen Jahr für 1,1 Milliarden Dollar aufkaufte. "Bayer und Conceptus haben das Ziel, mit Innovationen die Gesundheit von Frauen zu fördern", freute sich Andreas Fibig, der Vorstandschef von Bayer HealthCare Pharmaceuticals, da noch.

"Ich will nicht, dass andere das Gleiche mitmachen müssen"

"Jeder, der Schmerzen oder Komplikationen empfindet, egal aus welchem Grund, hat unser großes Mitgefühl", windet sich Edio Zampaglione, Vice President US Medical Affairs bei Bayer. Schuld trage Bayer aber keine: "Es gibt keine Verhütungsmethode, die hundertprozentig effektiv ist, und das steht auch klar auf unserem Beipackzettel."

Derlei "unerwünschte Ereignisse", so Zampaglione weiter, seien außerdem "in klinischen Tests" und einer Studie der US-Arzneibehörde FDA schon von Anfang an beobachtet und anerkannt worden. Die wiederum hält diese Nebenwirkungen für selten: Essure sei "als Mittel zur permanenten Sterilisierung zu 99,83 Prozent effektiv".

ANZEIGE

Michelle Garcia brauchte ihren Angaben zufolge allein fünf Monate, um herauszufinden, dass ihre Pein auf Essure zurückging. Es stellte sich demnach heraus, dass eine Spule zerbrochen und in Garcias Bauchraum gewandert war. Beide Spulen sollen operativ entfernt worden sein.

Garcia begann sich in einer Hilfsgruppe zu engagieren, die inzwischen mehr als 7000 Mitglieder hat: "Ich will nicht, dass andere das Gleiche mitmachen müssen." Auch schickte sie schon 2013 einen langen Brief an Bayer-Chef Dekkers, Investor-Relations-Chef Alexander Rosar und Sprecherin Tricia McKernan. "Frauen erleiden unsägliche Schmerzen und ernsthafte Beschwerden, die sie bekamen, nachdem Essure implantiert wurde", schrieb sie und warnte Bayer: "Sie besitzen jetzt einen Alptraum." Eine Antwort bekam sie nie.

Weshalb sie nun nach Köln pilgert, "in die Höhle des Löwen", wie sie sagt. Für ihren großen Aufritt am Dienstag hat Garcia sogar mit einem Coach öffentliches Reden trainiert: "Die Frauen verlassen sich auf meine Stimme."