Chances are you’ve heard of at least one permanent sterilization method other than tubal ligation, the industry standard surgery often referred to as “getting your tubes tied.” But we’d be willing to bet that that other form of permanent birth control isn’t called Adiana. Essure has taken the spotlight recently, which isn’t surprising since thousands of women say the birth control implants cause horrible side effects and members of Congress are even trying to get the device un-approved by the FDA.
Here’s Why Adiana, Essure’s “Sister” Device, Is No Longer Available.
But Essure, even though it’s captured most of the media attention, wasn’t the only alternative to tubal ligation approved in the last decade. Adiana, a very similar device, was approved in 2009, though it’s no longer available in the US. So what happened?
Google “Adiana” and you’ll find a page on the Mayo Clinic‘s website, in which Roger W. Harms, M.D., medical director for the site’s web content, responds to the reader-submitted question: “I heard the Adiana system is no longer available. What happened?” Harms begins by noting that, while Adiana is no longer available, “women who’ve already had the system implanted can rest easy.” He continues to explain that Adiana’s manufacturer, Hologic, stopped making the device “for financial reasons, not because there were any problems or safety concerns with the system.”
But is that true? Why and when, exactly, did Adiana go under?
Patent Lawsuits Brought Adiana Down
Adiana was first developed by a company called the Cytyc Corporation, which merged with Massachusetts-based Hologic, Inc. in 2007. Soon, Hologic was pushing for Adiana’s approval, using the same “premarket approval” process Conceptus, Inc. used to get Essure approved, and which has thus far shielded Essure’s current manufacturer, Bayer, from legal liability. Adiana was approved for sale in the US on July 6, 2009, and only five months later, Hologic had already found itself in hot water. None other than Conceptus, then-manufacturer of Essure, had filed a motion in a California federal court, seeking to stop Hologic from introducing its sterilization device to the US market.
Conceptus’ motion, however, was denied, and it took almost two years for Essure’s manufacturer to devise a response. On October 3, 2011, Conceptus sued Hologic, again in California, over patent infringement. After two weeks of trial, a jury found, in part, that Hologic had overstepped its bounds, infringing on claims outlined in Conceptus’ patent for a “Contraceptive Transcervical Fallopian Tube Occlusion Device And Methods.”
To be clear, the jury found that Hologic had infringed on specific aspects of Conceptus’ patent, descriptions not of the device itself, but of the method through which the device achieves sterilization, by causing scar tissue to grow around the implant. Manufacturing Adiana, the actual device, the jury said, was not an infringement on Conceptus’ rights. Even so, Conceptus was awarded over $18 million in damages.
Taking Adiana Off The Market
Four months later, Conceptus tried again to put a complete stop to its competitor’s product, filing a motion for permanent injunction that would have forced Hologic to stop making Adiana entirely. But the Honorable William Alsup, a District Judge in California, disagreed, according to About Health. In his judgment, Alsup wrote that Adiana was “not a copycat product […] Public health has benefited, and will continue to benefit, from having a choice of products for transcervical hysteroscopic sterilization.”
The legal battle, however, continued. Conceptus and Hologic fired motions back and forth, with Conceptus asking for more money, and Hologic asking for the jury’s verdict to be overturned. While all of their motions were denied, the company’s finally came to an accord on April 29, 2012. According to a Conceptus quarterly report filed with the Securities and Exchange Commission in May of that year, Hologic agreed to stop manufacturing and selling Adiana world-wide, if Conceptus agreed to rescind the $18 million settlement. Hologic also handed over the technology behind Adiana, giving Conceptus licensing rights to the device’s technology, but only within the domain of permanent sterilization.
It’s important to note that at this time Hologic was facing serious financial problems. Its acquisitions of other medical device companies, including the original developer of Adiana, Cytyc, had failed to pay off, and shareholders were selling their interests in the company quickly. Since then, the company has bounced back, but not on the strength of its discontinued permanent contraception product.
How Did Adiana Work?
Judge Alsup’s opinion, that Adiana was not a “copycat” of Essure, was not an idle one.
Unlike Essure, Adiana used low-level radiofrequency energy, transmitted by way of a catheter inserted into the fallopian tube, to burn away a thin layer of cells. After that, a small silicone implant would be inserted into the fallopian tube. As with Essure, scar tissue would eventually grow around the implants, blocking off the fallopian tube and preventing pregnancy.
Was It Effective?
In an early clinical trial, named EASE, 6 out of 570 women became pregnant within one year of receiving the implants, although half of those pregnancies were considered the result of physician’s error, and specifically, a doctor misinterpreting the results of a hysterosalpingogram, tests performed three months after implantation to ensure the devices are working properly.
The following year, according to a paper published in the journal Reviews In Obstetrics & Gynecology, three more patients became pregnant as a “result of method [device] failure,” and another pregnancy was reported 3.5 years after the women received Adiana. But at that point, Cytyc was no longer following most of the women initially registered in the trial. Only 133 patients were followed for the three years, leading Doctors Sophia N. Palmer and James A. Greenberg to estimate a true failure rate of 1.82% after two years, a rate that the researchers note was “higher than all methods evaluated in the[ir] study, except for the spring clip application,” a form of tubal ligation.
Adiana, it seems, was not as effective as its market competitors, which may partially explain Hologic’s willingness to part with the device.
How Did The Device Rank On Safety?
Clinical trials showed Adiana to have a “good safety profile,” according to Palmer and Greenberg, although numbers reported in a document reviewed by the FDA prior to the implant’s approval, suggest that 3% of patients studied experienced prolonged back pain during their first year, and another 3% reported pelvic pain during the same period. A full 6% suffered cramping unrelated to menstruation and 4% experienced abnormal vaginal bleeding. Each of these adverse events, by Cytyc’s own admission, were severe.
Essure and Adiana are markedly different implants. While Essure has a relatively long coil structure, the Adiana implant is much shorter. It’s been compared to a “grain of rice” elsewhere, and this may explain why no one in the Adiana clinical trials reported device migration or perforation. Adiana sits fully within the fallopian tube, without hanging into the uterus. Essure, on the other hand, projects into the uterus and has been linked to perforation and/or migration rates of up to 5%.
Despite these differences, take a look at this adverse event report, in which an Adiana patient describes a litany of terrible side effects strikingly similar to those reported for Essure:
“Since i have had the adiana implants inserted, i’ve been progressively symptomatic.
Beginning from the time i had the procedure, i’ve had severely heavy bleeding with periods, irregular periods, severe cramping, near constant pain in right lower abdomen (ovary?), stomach bloating to point of looking pregnant, severe lower back pain where i almost can’t even walk at times, hair loss, teeth are decaying rather rapidly when i sued to have healthy teeth, loss of appetite, impossible to lose any weight, dizzy spells, migraine headaches, irritability, ringing ears, allergies worsened, severe fatigue, skin breaking out, breast tenderness, brain fog/short term memory loss. I am sure that i’ve missed several symptoms.
I did not feel this horrible ever until after i got the adiana implants. I will be looking for a doctor educated with these to see, and will probably need a hysterectomy to remove them. Had 2 gyn appointments and mentioned the heavy periods to them, one ordered an ultrasound to look for possible issues, said ultrasound was ‘clear.’ “
While it may be true that Adiana was pulled from the market for largely financial reasons, from this, and other, adverse event reports, it appears the device had been linked to serious side effects, much like Essure.