FDA Fails to Protect Patients from PREVENTABLE Bayer Essure Harm.

Women harmed by sterilization coils push FDA to act

Updated: JUNE 6, 2017 — 7:38 PM EDT

by Marie McCullough, Staff Writer mmccullough@phillynews.com

The ranks of women harmed by Essure sterilization coils continue to grow, while the U.S. Food and Drug Administration’s efforts to inform them of the risks are not working, a 37,000-member advocacy group declared Tuesday.

Administrators of the six-year-old Facebook group Essure Problems said that in the first quarter of this year, the FDA received about 2,000 reports of women who underwent operations — usually hysterectomies — to remove coils that were causing complications such as pain and bleeding.

More than 9,000 removals have been reported since 2009, in addition to miscarriages, fetal deaths, and other problems, according to an analysis of the FDA’s “adverse events” reporting system. It was conducted by Madris Tomes, a former FDA manager who is the founding CEO of Device Events, based in York, Pa.

Angie Marie Firmalino, 44, a co-founder of the Essure Problem group on Facebook

“More than 15,500 adverse-event reports have been filed,” said Essure Problems cofounder Angie Marie Firmalino, 44, of Tannersville, N.Y., who needed a hysterectomy to get rid of fragments of broken coils. “We feel like the FDA needs to step in and take action. How much harm is acceptable for a non-lifesaving device?”

Asked for comment, the FDA said it “continues to review the available information about Essure, including reports of problems submitted to the FDA.”

The manufacturer, Bayer Healthcare, emailed: “We take all adverse events seriously. … We have reached out to many women who have reported complications … and provided any guidance we can. There are risks with all medical procedures.”

Surgeries to Remove Essure

This analysis of data from the FDA’s voluntary adverse events reporting system shows how many women needed surgery — either hysterectomy or fallopian tube removal — to remove the Essure sterilization coils because of severe problems such as pain and bleeding. Reports have been steadily increasing with growing awareness of the dangers.

Essure Problems has been among those pushing the FDA since 2013 to take Essure off the market. The coils, approved 15 years ago, are implanted in the fallopian tubes to scar them shut. The device is marketed as a simple, nonsurgical alternative to conventional tubal surgery.

Last year, the FDA ordered Bayer to add label warnings that Essure can cause chronic pain, organ perforation, and allergic reactions, and to create a “patient decision checklist.”

But about 200 women have contacted Essure Problems over the last six months to say that doctors did not tell them about the label warnings or use the three-page checklist.

“Unfortunately for many women, they are being implanted without informed consent,” administrators of the Facebook group emailed the FDA on Monday, demanding tougher action.

The FDA’s response, shared by the group: “We understand your frustration. We assure you, Essure is a high-priority issue for the Agency and we continue to take feedback like yours into consideration.”

Bayer, which acquired Essure in 2013, has been hit by thousands of lawsuits over the coils. Last year, the German-based company’s annual report said it incurred losses of $413 million in connection with the devices.

Bayer has said it does not know how many women have implants, just that about a million Essure “kits” had been sold worldwide, most in the U.S. The company recently announced it would discontinue sales in two small markets, Finland and the Netherlands.

Bayer Essure: Banned in Finland, the Netherlands, England, Wales, Scotland, Northern Ireland and Brazil

MORE PRESSURE ON BAYER AND FDA AS ESSURE DISCONTINUED IN UNITED KINGDOM

Holly Kelly Ennis

June 7, 2017  FiDA highlight

Victims of Essure celebrated again today after learning that the controversial Essure Sterilization device will be discontinued in the United Kingdom as of September 1, 2017. This follows on the heels of Essure being banned by Brazil in February and recently discontinued in Finland and The Netherlands, with rumors of other countries to follow by the end of the Summer. Bayer recently confirmed it will discontinue sales in the United Kingdom set forth in the letter below:

As Bayer discontinues the sale of the Essure device or countries ban it outright, this exerts greater pressure on the FDA to take affirmative action regarding  pulling the device from the market. For over three years, since the Essure Problems Administrators first shared their valid concerns regarding the device, they have heard the same tired response from the FDA, "We understand your frustration. We assure you, Essure is a high-priority issue for the Agency and we continue to take feedback like yours into consideration." Obviously, the FDA is not hearing the Group's concerns, nor is it a high priority.  In fact, despite repeated pleas from the Group regarding the making the Black Box Warning mandatory to physicians, the FDA designated it as a "guidance."  Accordingly, over 200 hundred women have contacted the Group since the BBW was implemented on November 15, 2016 to report that doctors failed to mention the BBW or use the Patient Decision Checklist.

The FDA responded yesterday that it, "continues to review the available information about Essure, including reports of problems submitted to the FDA."  These reports now total over 15,000 with over 9,000 reports of surgical removals since 2009. How long will the FDA continue to "review" the horrific stories of ladies significantly injured by the device before it takes some definitive action and revokes the PMA for the device? The job of the FDA is to protect the health of American citizens, not line the pockets of pharmaceutical and medical device companies. FDA, it  is time. Do Your Job. 

Questions regarding the Essure Sterilization Device can be directed to attorney Holly Ennis at 1-800-856-6405 or visit us online at www.Ennislaw.com

http://www.ennislaw.com/blog/more-pressure-bayer-and-fda-essure-discontinued-united-kingdom/

Bayer Essure: Failure to Inform Patients of Harm or to Follow Patient Outcomes

Bayer’s Essure Contraceptive Implant, Now With a Warning

By RONI CARYN RABIN            NOVEMBER 21, 201

Kim Myers used to compete in rodeo-style barrel horse races, but after being sterilized with an implantable device called Essure, the pain was so intense that she had to stop.

The device’s small metal and polyester coils had pierced her fallopian tubes, her doctor found, so the two implants were removed. But the sharp, laborlike pains didn’t really subside until three years later, when Ms. Myers had a hysterectomy.

Then her surgeon discovered the cause: A piece of metal coil was still embedded in her uterus.

• 
  

Kim Myers, 53, in the stable at her home in Wesson, Miss. Even after her two Essure implants were surgically removed, her sharp pains didn’t subside until she had a hysterectomy.

EDMUND D. FOUNTAIN FOR THE NEW YORK TIMES

“Doctors kept saying there was nothing wrong with me,” said Ms. Myers, 53, of Wesson, Miss. “I knew, with every fiber of my being, there was still something there.”

Ms. Myers was among a parade of women who testified before the Food and Drug Administration 14 months ago, saying they’d been injured by Essure and urging officials to pull the device from the market.

Essure comprises two small coils, made of a nickel alloy and a polyesterlike fiber, placed in the fallopian tubes through the vagina. The coils are designed to provoke an inflammatory response that causes scar tissue to form and block the tubes, a process that can take three months.

F.D.A. officials declined to withdraw the device, saying that Essure was safe and effective for many women although some experienced “very serious and sometimes debilitating problems.” But last week the agency ordered that a so-called black box warning be placed on the device’s packaging saying it could cause the kinds of injuries Ms. Myers sustained.

The implant may puncture the fallopian tubes and uterus, and travel into the abdomen and pelvic cavity, the warning notes, causing persistent pain and requiring surgical removal.

Officials at Bayer, which makes and sells Essure, say poor surgical skills are to blame for complications like Ms. Myers’s and insist there is no proof the device causes other reported side effects like chronic pain and autoimmune disorders.

“These are so common to women,” said Dr. Edio Zampaglione, Bayer’s vice president for United States medical affairs.

The F.D.A. also took the unorthodox step of guiding Bayer in the development of a new checklist of risks for doctors to review with patients before implanting the device. The three-page checklist is broken into five sections, each followed by a spot for the patient’s initials, and is to be signed by both doctor and patient.

The checklist is not mandatory, and critics say it does not mention many common side effects linked to Essure, like heavy, painful menstrual bleeding.

Some doctors complain that the checklist is intrusive and burdensome, may dissuade physicians from using the implants, and is based on anecdotes rather than scientific clinical trial data. Some providers, including Planned Parenthood, have said they will inform patients of the risks and benefits, but not ask them to sign the document.

“There’s no question there are complications, but there are risks and benefits to everything we do in medicine, and we don’t have good data to establish the magnitude of the problem,” said Dr. Christopher M. Zahn, the vice president of practice for the American College of Obstetricians and Gynecologists.

“Decisions like these should be made based on data that’s appropriately vetted, not a series of anecdotal reports,” Dr. Zahn said, referring to the black box warning and the checklist.

Dr. Zampaglione of Bayer noted that some studies had shown that other methods of permanent sterilization, not just Essure, have caused serious long-term adverse events as well.

The F.D.A. approved the implant in 2002 after a fast-track review process that prioritized the device because it was the first sterilization procedure for women that could be done in a doctor’s office, without an incision and without general anesthesia. It offered an option to tubal ligation, commonly known as having one’s “tubes tied.”

Pain and other serious side effects emerged in the clinical trials of Essure. The device could not always be implanted, and failed to block the tubes in a significant percentage of patients. According to the new checklist, nearly one in 10 women who try Essure cannot rely on it to prevent pregnancy.

The F.D.A. approved Essure after trials lasting a year or two, even though the implant was meant to last for life. By the end of last year, the agency had received nearly 10,000 reports of injuries and pregnancies related to the device, as well as reports of a very small number of fatalities.

Many doctors who insert the implant do not know how to remove it.

By contrast, drug trials are required to have a comparison group of participants who are given a placebo.

Earlier this year, Bayer agreed to begin tracking 1,400 women who have the device implanted over the next five or six years. The study is supposed to report final results in 2023, but is already behind schedule.

This study has a comparison group of sorts: It will also follow 1,400 women who choose a more traditional form of sterilization using laparoscopic surgery.

The women will be followed for three years after the sterilization procedures to see how many in each group develop complications like chronic pelvic pain, heavy bleeding and autoimmune disorders, as well as how often each intervention fails, leading to pregnancy.

Researchers will also track how many women with Essure develop such severe complications that they have to undergo surgery to remove the implants.

http://mobile.nytimes.com/2016/11/21/well/bayers-essure-contraceptive-implant-now-with-a-warning.html?referer=https%3A%2F%2Fwww.google.com%2F

Please Support Ariel Grace's Law HR5403

June 10, 2016

The Honorable __________________

___________________ HOB

Washington, DC 20515

Dear ________________________, 

H.R.5403 Ariel Grace’s Law  https://www.govtrack.us/congress/bills/114/hr5403

On June 8, 2016, Congressman Mike Fitzpatrick (R-PA) and Congresswoman Louise Slaughter (D-NY) introduced an important new bi-partisan bill.  This bill seeks to remove the preemption protection granted to Class III medical devices which receive initial premarket approval by the FDA.  Accordingly, manufacturers of medical devices, which  later may be shown to be defective and dangerous, will not be automatically shielded from liability.  Often the threat of civil litigation is the necessary force to ensure that manufacturers provide medical devices that are both effective and more importantly, safe. A similar bill had over 100 cosponsors several years ago, and we hope to drive similar bipartisan support.

The bill is aptly named, Ariel Grace’s Law, after Ariel Grace Burrell, whose stillborn birth was caused by a Class III medical device. Kristiana Burrell has given her blessing to have the bill named after her daughter and the bill was introduced on the one year anniversary of the birth/death.

This  bill is  applicable to all Class III medical devices. It is an amendment to an already existing statute and merely amends the statute to allow access to courts for those injured by defective medical devices and is states as follows:              

This Act may be cited as the “Ariel Grace’s Law

(a)  Amendment- Section 521 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C 360k) is amended by adding at the end the following:

(b)  NO EFFECT ON LIABILITY UNDER STATE LAW- Nothing in this section shall be construed to modify or otherwise affect any action for damages or the liability of any person under the laws of any State.”

(c)  EFFECTIVE DATE; APPLICABILITY. - The amendment made by subsection (a) shall

(1) Take effect as if included in the enactments of the Medical Device Amendments of 1976 (Public Law 94-295): and

(2) Apply to any civil action pending or filed on or after the date of the Act.

As your constituent, I strongly urge your support of this bill. It is unconscionable and unjust that manufacturers who have a medical device approved by the FDA pursuant to a  premarket approval process can be forever shielded from liability and immune from suit even when the device later proves to be dangerous and/or defective and causes injury to device users. It was never the intent of the Federal Food, Drug and Cosmetics Act to provide blanket immunity for medical device manufacturers for defective devices placed into the stream of commerce.  Quite simply, there is no plausible reason nor rationale for the failure to support this amendment, which serves to protect your constituents.  Accordingly, I strongly urge you to join forces with Representatives  Fitzpatrick and Slaughter and make this bill into law as soon as possible.

My best,

Bayer Essure: Permanent Birth Control Pain

Some women say a permanent birth control is causing permanent pain

Leslie Rhode/KXAN Special Contributor  

Published: May 17, 2016, 9:00 pm Updated: May 17, 2016, 11:03 pm

AUSTIN, TX (KXAN) — Essure, a permanent birth control device, is under scrutiny by the Food and Drug Administration after thousands of women have complained of long-lasting painful effects they say are related to the birth control. The manufacturer, Bayer, estimates about 750,000 women are using Essure, and most of them are in the United States.

After Angela Otwell delivered her second child, she thought long and hard about whether or not she wanted a permanent form of birth control. She says her last pregnancy had complications due to an autoimmune condition, but she claims those health challenges cannot compare to the physical and emotional pain she has endured since she got Essure.

The Belton mom was only 28 years old when she had the birth control device implanted in January 2015. Five months later, she had an ovarian cyst rupture she blames on her birth control.

“Ovarian cysts just feel like someone took a very long metal rod that’s sharpened at the end and takes it and skewers it through your body wherever it is,” said Otwell.

For Otwell, the most frustrating part of her life now is the constant fatigue. She says she has lost a great deal of weight and energy since the day she had the permanent birth control implanted. With two young children still not in school, she says she feels so guilty not being the energetic mom her two children deserve.

“I go to the grocery store and that’s about it. I really want a shot at being a mom. I dream of taking the kids to Disney World or, you know, hiking. I just hope I get that opportunity.”

Atwell isn’t alone.

Felicia Crossland lives with fatigue and pain which she also claims was caused by Essure. The Liberty Hill mother loved the idea that the permanent form of birth control did not require anesthesia and down time like having her tubes tied would, so she opted for the devices after her second child. In the years since, she says she often suffers bloating and severe menstrual pain. By the end of most days, Crossland claims the pain becomes too much to bear.

“What happens most nights is there’s this incredible pain that builds in my pelvis and works its way down in my legs,” explained Crossland. “I would like to say it’s something as simple as a pinched nerve, but I really don’t think it is.”

How Essure Works

Doctors insert the small Essure devices into the fallopian tubes through the cervix. Within three months, scar tissue grows around the coils creating a barrier that prevents sperm from reaching the eggs. According to the company’s website, most women go home 45 minutes after the procedure.

Patients are supposed to go back to the doctor after three months for a confirmation check to make sure Essure is working properly to prevent pregnancy. The manufacturer’s website warns women to use other forms of birth control until they pass the confirmation test. Essure marketing indicates the product is 99 percent effective at “permanently preventing pregnancy.”

The Essure coils are made of materials that include a nickel-titanium alloy, a material used in other medical devices like heart stents. The packaging warns patients with nickel allergies may experience an allergic reaction with symptoms like rash, itching and hives. The coils do not contain hormones.

Essure was approved by the Food and Drug Administration in 2002. At the time, the birth control was manufactured by Conceptus, Incorporated. Bayer acquired Conceptus in 2013. Essure received the FDA’s most stringent review before it was marketed and Conceptus was required to conduct two post-approval studies.

According to FDA records, approximately 10,000 complaints have been filed complaining about health complications related to the use of Essure. Records show most women reported pain/abdominal pain, menstrual irregularities headaches and fatigue. The agency says some people reported more than one problem.

The FDA’s website states, “confirming whether a device actually caused a specific event can be difficult based solely on information provided in a given report.”

On Sept. 24, 2015, the FDA held hearings on the growing number of complaints regarding the adverse effects of Essure. Doctors and patients testified about their experiences with the permanent birth control device.

After the hearing, the FDA ordered Bayer to conduct a post-market study to gather more data about Essure’s benefits and risks. The agency also drafted a boxed warning to make sure a woman knows the risks associated with the product and a patient checklist that doctors review with a woman to make sure she understands the benefits and possible health complications.

Bayer still claims the birth control option is safe for most women and the benefits outweigh the risks.

“The data around the safety and efficacy of Essure has been examined in the company and by the FDA, and the data does not support taking it off the market,” said the Director of US Medical Affairs, Women’s Health Bayer, Dr. Patricia Carney. “Even in the latest statements from the FDA–for the majority of women– essure is a good option.”

The FDA took public comment on the draft box warning and patient checklist for 60 days. That period ended on May 3, 2016.

A bipartisan group of U.S. lawmakers introduced the E-Free Act (H.R. 3920) on Nov. 4, 2015 in hopes of pulling Essure off the market. The bill would require the FDA to withdraw its approval of the permanent birth control.

Living with the Pain

Angela Otwell and Felicia Crossland both say they do not blame their health problems on their doctors who implanted Essure, but rather the device itself.

Otwell and Crossland say they have contacted a new physician who has agreed to remove their birth control devices. Because of the way Essure coils are implanted, the women say the coils cannot be removed without a complete hysterectomy, which is the removal of the uterus.

Both women are waiting on the wording of the FDA’s final boxed warning of Essure, but both wish it would just be removed from the market altogether. There has been no action on the E-Free Act in Washington, D.C.

Bayer Alters 'Essure' Adverse Event Reports

Fitzpatrick Questions FDA About Essure Reporting

April 19,2016 (FiDA highlight)

WASHINGTON, D.C. — Congressman Mike Fitzpatrick (PA-8) sent the following letter to the Food and Drug Administration Tuesday regarding dramatic changes in the reporting of adverse events caused by the medical device Essure:

Dear Dr. Shuren,

Information has been brought to my attention that shows a dramatic change in how Adverse Event Reports relating to the permanent sterilization device Essure were submitted to the FDA coinciding with the agency’s announcement that it was reviewing the safety of the device.

As you know, when a manufacturer submits an Adverse Event Report to the FDA one of the data fields to be filled is “Reporter Occupation.” Examples of how that field can be coded by the manufacturer include “Physician,” “Health Professional,” “Nurse,” “Pharmacist,” “Paramedic,” “Risk Manager,” and “Other.”

As it relates to Essure, from January 2002 through June 2015, the manufacturer of the device submitted nearly 600 Adverse Event Reports in which the “Reporter Occupation” field was coded as “Physician.” This corresponds to the narrative information included in the report in which it clearly states the information in the report came from a medical doctor, a Gynecologist/ Obstetrician, a physician, or other similar term.

However, this coding changed dramatically in July 2015. I find this extremely concerning given the fact that on July 17, 2015, the FDA announced it was reviewing the safety and effectiveness of the Essure device.

After the FDA’s public announcement, Adverse Event Reports received by the agency from the manufacturer of Essure no longer coded reports from medical doctors as Physician reports. Instead, almost every report received from a physician between August 2015 and February 2016 listed the Reporter Occupation field as “Other.” This is a clear change from how the manufacturer coded prior to FDA’s announcement despite the same keywords, like medical doctor or Ob/Gyn, being found in the narrative portion of the reports. A similar change was noted in reports received from nurses.

I respectfully request the FDA to review the Adverse Event Reports from physicians and provide answers the following questions:

1. Did the FDA request the manufacturer to change how it was coding physician reports?

2. If the FDA did not request this change, is there a legitimate basis by which a manufacturer would suddenly change how they code reports from medical doctors and Ob/Gyns and code the occupation as “Other” instead of as “Physician”?

3. Was the FDA aware of this change?

4. Did the manufacturer of Essure notify the FDA it was changing how it reported the Report Occupation field within the Adverse Event Reports?

5. Was the FDA aware of this change prior to the September 24, 2015 Advisory Committee meeting related to Essure?

6. Does the FDA review Adverse Event Reports with the Reporter Occupation field coded as “Physician” differently than reports coded as “Other?” Are “Physician” reports given more weight when FDA is reviewing Adverse Event Reports than reports coded as “Other?” If so, please describe the differences in how the FDA reviews a report received from a physician compared to other types of reports.

7. If the FDA were to generate a list of Adverse Event Reports received from “Physicians” about Essure, would reports coded as “Other” be included? If the Reporter Occupation is listed as “Other,” does the FDA conduct additional analysis of the narrative portion of the report to determine if the report came from a medical doctor?

8. Is it illegal for a manufacturer to knowingly manipulate data listed on an Adverse Event Report?

9. What are the penalties for knowingly submitting false information to the FDA in an Adverse Event Report?

10. Has the FDA ever held a manufacturer accountable for falsifying or intentionally miscoding information submitted in an Adverse Event Report?

I appreciate your prompt attention to this request. Should you have any questions, please do not hesitate to contact Justin Rusk on my staff.

Sincerely,

_______________________________________________________

Statement of Dr. Zuckerman on Bayer’s adverse reports on Essure

Statement of Dr. Diana Zuckerman, President

National Center for Health Research

Bayer’s vague labeling system of Essure contraceptive problems brought to Congress’s attention

April 19, 2016

This seems to be a clear attempt by Bayer to make the adverse reports regarding Essure seem less credible. By counting physicians and other health professionals as “other,” Bayer assumed correctly that the FDA would take them less seriously. And, the same thing would happen when the FDA reported those adverse events.

This is not the first time that Bayer has misrepresented information about the risks of Essure, and it is time for the FDA to realize that they can’t trust the information that the company is providing.

FDA Violations and Highest Risk FDA Bayer Essure

Original Essure Manufacturer Had Long History Of FDA Violations

By Michael Monheit    March 10th, 2016

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

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

“Unanimous Approval” & Growing Profits

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

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

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

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

Essure Soon Marred By Manufacturing & Side Effect Reporting Problems

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

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

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

Spotty Record-Keeping & Rejected Raw Materials

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

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

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

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

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

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

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

FDA Inspector Discovers Unreported Adverse Events

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

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

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

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

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

Conceptus Denies Device Failure

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

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

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

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

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

"Fuck You", Bayer Essure!

The Controversial Birth Control That Destroys Your Body

by Amy Martyn 

APR 6 2016 4:55 PM

COURTESY OF BAYER

Despite thousands of women's complaints about Essure—ranging from uterus perforation to miscarriage—the FDA allows the birth control device to remain on the market. Jessica Smith describes how her Essure implant turned her body against her.

Jessica Smith's unedited, angry comment is still on the FDA's website, much to her surprise. "You had an opportunity to remove Essure from the market. You blew it," it reads. Despite complaints from women who say they've experienced painful and severe side effects such as constant cramping, still births, ectopic pregnancies, and miscarriages from the sterilization implant Essure, the Food and Drug Administration has so far allowed drug maker Bayer AG to continue to selling its product.

"Like all forms of birth control, Essure is not perfect and women may become pregnant despite use of the device," Dr. William Maisel, the FDA's Center for Devices and Radiological Health director, said in a statement. Due to multiple lawsuits regarding Essure and a recent congressional investigation, the FDA announced in February that it would place a "black box" warning on Essure and order Bayer AG to conduct more safety studies on the device.

In the meantime, as Essure remains for sale but under federal review, the FDA has invited patients to leave public comments on its website about their experience with the controversial birth control implant. "You could have allowed us the opportunity to be compensated for our horribly damaged bodies, careers, relationships and lives. But you didn't. You blew it," Jessica's post goes on. "You blew it worse than the sex workers blew your Deputy for science at the FDA Center of Devices and Radiological Health back in 2012," she ends the post, crudely referencing the 2012 arrest of the FDA's Maisel in an alleged prostitution sting.

Jessica keeps a cheerful face on, but, like other woman who complain about Essure, she is also clearly bitter. She developed a painful condition called pelvic adhesion disease, in which her reproductive system is fused to her digestive system due to scar tissue. She and her doctors believe this is a result of the Essure implant.

In an interview at her apartment in North Texas, joined by two of her close friends, Jessica showed Broadly her extensive medical records and described the chaotic process of trying to find a doctor who might be able to "fix" her.

Jessica at home

After Jessica gave birth to fifth baby in 2013, she decided to go on a more permanent form of birth control. She considered her options: She could have had her "tubes tied,"—known medically as tubal ligation, the older and more common form of female sterilization—but she decided not to because she had no guaranteed paid sick days left to recover from surgery. Essure then seemed to be the more practical choice; Bayer AG claims that, unlike tubal ligation, Essure is a not a surgery but a quick, non-invasive outpatient procedure. Jessica says her doctor told her the recovery time would be a day.

She says she felt the pain immediately as her doctor implanted the device. She remembers being told to take an Advil. "She's a really conservative doctor, so the impression I had is she thought I was being kind of a weenie," Jessica recalls.

When Jessica got home that night, she says she started passing large tissue. According to Jessica, the nurse on call "said that sounded normal and I didn't need to come back to the doctor for that. And I was like, 'If that's normal, why isn't that one of the side effects listed?'"

You had an opportunity to remove Essure from the market. You blew it worse than the sex workers blew your Deputy for science at the FDA Center of Devices and Radiological Health back in 2012.

The bleeding didn't stop. Not for 10 months. Jessica says that she felt as though she was on her period through the entire 10-month span. She felt a constant pain in her abdomen, which vacillated between feeling bearable to being so intense that she could not stand, and therefore couldn't work.

She made regular trips to the emergency room. Doctors at the E.R. diagnosed her with vague conditions like "abdominal pain" and told her to return to her implanting physician. "I would hang my hat that you have an STD," she remembers one doctor telling her.

Another told her she was suffering from the "period from hell" and prescribed her hormonal birth control pills. Doctors gave her forms about things that cause pelvic pain—conditions like STDs, fibromyalgia, and endometriosis. Nothing pointed to Essure. "Their findings didn't show anything wrong. How can you treat what's not wrong?" she says.

Elizabeth Fluegge, another Essure victim who needed to have her device surgically removed

Jessica returned to her gynecologist's office, where they couldn't find anything wrong, either. At one appointment, she says, her implanting physician's partner "accused me of being a pill seeker and said it's not possible for Essure to hurt because it's so small." In the same breath, however, Jessica says the doctor told her that, unlike her partner, she does not implant Essure, "because leaving metal in soft tissue is not a good idea.'"

The retailer where Jessica works initially denied her paid sick leave but then gave her the days retroactively, allowing her to support herself and her children on the days that she was in too much pain to work. Jessica eventually realized that the pain was at its worst during the time in her cycle when she was ovulating and when she was menstruating.

A year later Jessica found what she believed would be a long-term solution to her pain: a relatively unknown surgery called "Essure reversal." So-called Essure reversals are expensive, complicated procedures performed by fertility doctors; they're not covered by insurance. They promise the woman the chance to get their Essure removed from their body without undergoing a drastic hysterectomy procedure. What's more, doctors who perform Essure reversals say that women who previously had Essure may even be able to get pregnant again.

Jessica chose a doctor in Florida, who charged $6,000 for the procedure. "He said a third of his patients get pregnant afterward," Jessica says. Jessica's fiancée took out a medical loan from a financial firm the doctor conveniently provided a link to on his website. Initially the surgery seemed to cure her pain.

But the relief didn't last, and the pain returned. "It would be kind of intermittent, and then the periods of pain would be longer and longer until I was just in pain all the time again," she says.

In Austin, Jessica visited a new doctor—one who has become popular with Essure patients for offering them advice on Facebook and setting aside time at his practice to meet with them. When he examined Jessica, she says, she was in so much pain he warned her that he may not be able to help. "There isn't a recognized safe method to remove Essure," Jessica says. "So basically it's just doctors making stuff up without much oversight or regulation or anything."

The doctor told her he could remove the scar tissue causing her pain, but that it may grow back, and if it did, she would need to see a different doctor to perform the next, more technically complicated surgery. Jessica took the gamble and underwent her second post-Essure surgery with him anyway.

Jessica's ovaries, the doctor's report explained, were attached to her pelvic side walls, and "her right ovary [had] a significant attachment to the colon.

"The patient, upon inspection of the pelvis, had extensive adhesive disease of the colon and small bowel... she also had severe pelvic disease from the top of fundus down to the endocervix," reads the doctor's surgical report, which Jessica saved. Jessica's ovaries, his report explained, were attached to her pelvic side walls, and "her right ovary [had] a significant attachment to the colon."

This surgery, like the last, only gave Jessica temporary relief. In pain and missing more work again, Jessica searched for another doctor and found one who still implants Essure in women but who also took her pain seriously.

On March 22, she scheduled her third post-Essure surgery. Beforehand, her doctor told her he would not perform a hysterectomy unless it was absolutely necessary.

"Out of surgery," Jessica texted me the next day. "I had a hysterectomy. "They took my uterus, cervix and tubes. I'm sad... This is not what I wanted. We are still paying for my reversal."

Her doctor had found so much scar tissue that he had little choice but to remove much of her organs. "He told me that Essure works very well for most women. Just not for me," she says. "'And 28,000 other women,' I said, because I am relentless."

Now Jessica is recovering and hoping to return to work. She recently busted a stitch open in her belly button after hiding Easter eggs with her children, but says it's otherwise going okay. She still has her job and is waiting for word on if her disability leave will be covered during her recovery time. In the meantime, she has joined a lawsuit against Bayer AG. Though the company's special FDA approval bars it from lawsuits, attorneys are attempting to sue the company anyway, and they recently won a surprising, minor success from a judge who allowed two claims against the company to go forward.

Jessica also leans on her friends for support. Her two friends and coworkers who sat in the interview with her have taken her to the hospital or watched her children when she was in too much pain to stand. And, in an effort to help Jessica with her medical bills, they even organized a surprise fundraiser last month, complete with a band and dozens of vendors at a local bar. The name of their event, written out in all-caps on the marquis of the bar, summed up the attitude that Jessica has about the last past two years of her life: "FUCK YOU, ESSURE."