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. micro catheter

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.