Bayer faces dilemma over fate of con­tro­ver­sial Es­sure de­vice

Modern Healthcare - - NEWS - By Elizabeth Whit­man

Af­ter giv­ing birth to her third daugh­ter in 2013, Rina Kel­logg was done hav­ing chil­dren. She wanted to have her tubes tied, but her OB-GYN sug­gested she get a ster­il­iza­tion im­plant called Es­sure.

“She said it was the lat­est and great­est tech­nol­ogy, and that it was like putting a stent in your heart,” said Kel­logg, a 36-year-old liv­ing in Spring, Texas. “I trusted her and I went ahead and did the pro­ce­dure.”

Es­sure con­sists of two sets of tiny coils—one of stain­less steel, wound with poly­eth­yl­ene tereph­tha­late polyester fibers, nes­tled in a larger nickel-ti­ta­nium coil—that are im­planted in a woman’s fal­lop­ian tubes. Scar tis­sue is sup­posed to form around them, se­cur­ing the coils and block­ing the tubes so that eggs can­not be fer­til­ized.

Af­ter the im­plan­ta­tion in Au­gust 2014, Kel­logg was in pain. But she as­sumed her body needed time to ad­just. By Christ­mas, how­ever, she was in agony with cramp­ing and pro­fuse bleed­ing. Dur­ing a fol­low-up visit, Kel­logg’s doc­tor dis­missed her symp­toms as re­sults of stop­ping hor­monal birth con­trol. She also told Kel­logg, 33 at the time, that she was “get­ting older.”

The bleed­ing lasted for more than a year. At 34, Kel­logg had a hys­terec­tomy to re­move the de­vice. Still, her med­i­cal prob­lems per­sisted. Since 2013, she has been di­ag­nosed with chronic fa­tigue, ir­ri­ta­ble bowel syn­drome, fi­bromyal­gia, in­som­nia and other med­i­cal is­sues—a far cry from when she worked 50-hour weeks as a spe­cial-ed­u­ca­tion teacher, all while preg­nant with her sec­ond child.

“I lit­er­ally went from hav­ing no med­i­cal prob­lems be­fore this, to bleed­ing for about 424 days, to hav­ing a hys­terec­tomy as a young mother with three kids,” Kel­logg said. “I’m still hav­ing is­sues, even though I got it out.”

Kel­logg is among a le­gion of women who are speak­ing up about se­vere med­i­cal prob­lems they say were trig­gered by Es­sure. In re­cent years, thou­sands of women al­leg­ing harm from Es­sure have filed law­suits against Bayer, the de­vice’s man­u­fac­turer.

Some ex­perts and physi­cians pre­dict that these ef­forts will drive Es­sure off

Last year, im­pair­ment losses con­nected to Es­sure cost Bayer $413 mil­lion, ac­cord­ing to the com­pany’s 2016 an­nual re­port. The com­pany ex­pects it will face even more law­suits.

the mar­ket, not nec­es­sar­ily be­cause it’s deemed un­safe, but be­cause it will no longer be mar­ketable. In the past, other de­vice and drug­mak­ers have done just that af­ter law­suits, set­tle­ments and Food and Drug Ad­min­is­tra­tion safety warn­ings—not for­mal re­calls—made the prod­ucts a big­ger li­a­bil­ity than they were worth. Un­til com­pa­nies draw that line, pa­tients still face risks.

“I’ll be sur­prised if Es­sure is be­ing sold 15 months from now,” said Erik Gor­don, a pro­fes­sor at the Ross School of Busi­ness at the Uni­ver­sity of Michi­gan. “If Bayer doesn’t pull it, I think the FDA will.”

Es­sure was de­vel­oped in the 1990s by Cal­i­for­nia-based com­pany Con­cep­tus, which Ger­many-based Bayer ac­quired in 2013. Be­tween Nov. 4, 2002, when the FDA ap­proved Es­sure, and Dec. 31, 2016, the FDA re­ceived 14,919 re­ports doc­u­ment­ing de­vice mi­gra­tion, or­gan per­fo­ra­tion, se­vere pain and a slew of other ad­verse re­ac­tions.

In 2016, the FDA man­dated a black box warn­ing, the high­est-level alert, for Es­sure. Pa­tients and their ad­vo­cates con­tinue to call for it to be taken off the U.S. mar­ket, as Brazil did in Fe­bru­ary, when it sus­pended the im­por­ta­tion, dis­tri­bu­tion and mar­ket­ing of Es­sure.

Last year, im­pair­ment losses con­nected to Es­sure cost Bayer $413 mil­lion, ac­cord­ing to the com­pany’s 2016 an­nual re­port. The com­pany ex­pects it will face even more law­suits.

When asked whether it was con­sid­er­ing pulling the de­vice from the mar­ket, Bayer said it “stands be­hind Es­sure and its pos­i­tive ben­e­fit-risk pro­file.”

“The safety and ef­fi­cacy of Es­sure, the only FDA-ap­proved method of per­ma­nent birth con­trol with a non-in­ci­sional pro­ce­dure, are sup­ported by more than a decade of science as well as real-world clin­i­cal ex­pe­ri­ence,” ac­cord­ing to Bayer.

But if Bayer does stop mar­ket­ing the de­vice, it would not be un­prece­dented. Other com­pa­nies have with­drawn med­i­cal de­vices from the mar­ket vol­un­tar­ily in the past with­out the FDA is­su­ing a re­call.

In 2014, John­son & John­son pulled three types of power mor­cel­la­tors, which are used to ex­tract fi­broid tu- mors, af­ter they were found to have a high risk of spread­ing can­cer. Those de­vices con­sti­tuted a small por­tion of its rev­enue.

The FDA did not ban or re­call the mor­cel­la­tors, but it sent a safety ad­vi­sory to doc­tors warn­ing them not to use the de­vices for uter­ine fi­broids. Af­ter that no­tice went out, J&J pulled them off the mar­ket.

“J&J could’ve kept sell­ing it,” Gor­don said, re­fer­ring to the mor­cel­la­tors.

Data from the ECRI In­sti­tute, a Philadel­phi­abased not­for-profit that re­searches pa­tient safety is­sues, sug­gest that some providers are aban­don­ing Es­sure.

In other cases, J&J stopped sell­ing Pin­na­cle hip de­vices in 2013, the same year it paid $2.5 bil­lion to com­pen­sate pa­tients over a dif­fer­ent prod­uct, ASR hip de­vices. In 2012, its Ethicon di­vi­sion stopped sell­ing mesh uri­nary im­plants, over which women had filed thou­sands of law­suits against the com­pany al­leg­ing harm. The fol­low­ing year, a jury or­dered J&J to pay $3.35 mil­lion to a woman be­cause the com­pany did not ad­e­quately warn her doc­tor about the im­plant’s po­ten­tial risks.

Last Oc­to­ber, St. Jude Med­i­cal re­called nearly 400,000 de­fib­ril­la­tors, whose bat­ter­ies could fail un­ex­pect­edly. The FDA re­cently warned that the com­pany had nev­er­the­less some­how al­lowed seven pa­tients to be im­planted with them, even af­ter the re­call. One stock an­a­lyst said that could serve as a PR “black eye” for Abbott, which ac­quired St. Jude in Jan­uary, the Min­neapo­lis Star Tri­bune re­ported.

Costly lit­i­ga­tion, set­tle­ments and neg­a­tive pub­lic­ity are a few pre­cip­i­tat- ing fac­tors that can push a com­pany over the tip­ping point to pull a de­vice.

“For the com­pany, it’s more of a busi­ness de­ci­sion,” Gor­don said. “At some point, your risk man­age­ment peo­ple look at it and say it’s just too fi­nan­cially risky to keep sell­ing these things.”

Bayer said it has sold 750,000 Es­sure de­vices since 2002, the ma­jor­ity of them in the U.S. It does not re­lease an­nual sales fig­ures, but the 750,000 fig­ure hasn’t changed for at least four years. In a 2013 fil­ing to the Se­cu­ri­ties and Ex­change Com­mis­sion, Con­cep­tus said it had dis­trib­uted that same num­ber of Es­sure de­vices.

Data from the ECRI In­sti­tute, a Philadel­phia-based not-for-profit that re­searches pa­tient safety is­sues, sug­gest that some providers are aban­don­ing Es­sure. In 2014, 365 mem­bers of ECRI’s PriceGuide ser­vice spent $8.34 mil­lion to pur­chase 4,836 Es­sure de­vices. In 2015, 299 mem­bers spent $5.79 mil­lion on 3,244 de­vices. The fol­low­ing year, the num­bers fell fur­ther, with 180 mem­bers spend­ing $1.98 mil­lion on 1,122 de­vices.

The data have a few im­por­tant lim­i­ta­tions. The ma­jor­ity of PriceGuide mem­bers are hos­pi­tals and sur­gi­cal cen­ters. The num­bers do not nec­es­sar­ily in­clude pur­chases by physi­cians. They also cover only a span of three years, and so it’s not clear whether the de­cline is the con­tin­u­a­tion of sales trends prior to 2014 or whether it rep­re­sents a change.

Still, physi­cian feed­back cor­rob­o­rates the di­min­ished in­ter­est in Es­sure in­di­cated by those de­clin­ing sales, re­gard­less of prior trends.

In Fe­bru­ary, Modern Health­care polled OB-GYNs about Es­sure through Sermo, an on­line so­cial net­work for doc­tors. Of the 387 OB-GYNs sur­veyed, 272 said they had im­planted Es­sure de­vices in pa­tients. Of those doc­tors, 175, or 64%, said that their Es­sure im­plants per year in the past five years had de­clined sig­nif­i­cantly; 42 doc­tors, or 15%, said the im­plants had de­clined a lit­tle.

“In the end, the doc­tors are the big­gest gate­keep­ers,” Gor­don said. If pa­tients tell physi­cians that they don’t want a de­vice or drug, then physi­cians,

The FDA has re­quired Bayer to con­duct a new study of Es­sure’s ben­e­fits and risks that it hopes will shed light on the com­pli­ca­tions that af­flict women who have Es­sure, com­pared to those who have tubal lig­a­tion.

fear­ing mal­prac­tice suits, be­gin to aban­don it, he ex­plained. If sales fall, then the com­pany loses its in­cen­tive to keep sell­ing the de­vice, es­pe­cially if it’s in­creas­ingly con­nected with law­suits and neg­a­tive at­ten­tion.

In anony­mous com­ments sub­mit­ted with the Sermo poll, OB-GYNs in the U.S. of­fered a mix of opin­ions. “Es­sure pro­vides a form of per­ma­nent ster­il­iza­tion that is par­tic­u­larly help­ful for pa­tients who are not good can­di­dates for ab­dom­i­nal surgery,” one said. “How­ever, since re­versible op­tions . . . are equally ef­fec­tive, I will be mon­i­tor­ing the risk-ben­e­fit pro­file of Es­sure closely.”

An­other said that when the pro­ce­dure goes well, Es­sure was “a great method of ster­il­iza­tion,” but “when things don’t go well (there) can be sig­nif­i­cant is­sues try­ing to re­move the im­plants.”

Sev­eral said they had stopped of­fer­ing Es­sure or sig­nif­i­cantly scaled back due to side ef­fects.

One OB-GYN weighed in on the “para­noia” around Es­sure, call­ing it “one of the worst is­sues I deal with” and say­ing it had caused the doc­tor to per­form many more un­nec­es­sary la­paro­scopies.

Amanda Yunker, an as­sis­tant pro­fes­sor of ob­stet­rics and gy­ne­col­ogy at Van­der­bilt Uni­ver­sity School of Medicine in Nashville, said she has seen “a steady in­crease” in the num­ber of pa­tients seek­ing re­moval in the past few years. She es­ti­mated she has re­moved 80 to 100 Es­sure de­vices, none of which she im­planted.

Yunker’s prac­tice is cen­tered around pelvic pain, and she has no­ticed that such pain is a com­mon symp­tom af­ter pa­tients had Es­sure im­planted. “You’re never 100% sure, be­cause pain is very sub­jec­tive and it’s mul­ti­fac­to­rial. There could be a lot of things that con­trib­ute to pelvic pain,” Yunker said. Nev­er­the­less, “the ma­jor­ity of them def­i­nitely had im­prove­ment in their pain when it (Es­sure) was re­moved,” she said.

No med­i­cal de­vice or drug is per­fectly safe. The fun­da­men­tal chal­lenge with Es­sure is know­ing which pa­tients are apt to do well with it and which are prone to se­vere, even de­bil­i­tat­ing com­pli­ca­tions. The FDA’s po­si­tion is that those in the for­mer cat­e­gory should have ac­cess to the de­vice, even while those who fall in the lat­ter are pro­tected.

“The un­for­tu­nate thing is, we don’t know where peo­ple fall prior to im­plant­ing the de­vice,” Yunker said.

Many stud­ies fo­cus­ing on Es­sure have com­pared as­pects of the pro­ce­dure, such as meth­ods of pain man­age­ment or fol­low-up test­ing. They have not sought to find re­la­tion­ships be­tween a pa­tient’s med­i­cal pro­file prior to the pro­ce­dure and her out­comes after­ward.

Ac­cord­ing to a sys­tem­atic re­view of Es­sure by re­searchers in Fin­land and pub­lished in the jour­nal Fer­til­ity and Steril­ity in 2010, long-term data on Es­sure’s safety and ef­fi­cacy were still un­avail­able, and there were no ran­dom­ized con­trolled stud­ies of the de­vice. The re­searchers also noted that most stud­ies on Es­sure have been funded by Bayer.

The FDA has re­quired Bayer to con­duct a new study of Es­sure’s ben­e­fits and risks that it hopes will shed light on the com­pli­ca­tions that af­flict women who have Es­sure, com­pared to those who have tubal lig­a­tion.

Es­sure pa­tients, es­pe­cially women who are part of the Face­book group Es­sure Prob­lems, and their ad­vo­cates ar­gue that the only way to pre­vent fur­ther harm is to re­move the de­vice from the mar­ket en­tirely.

But the FDA main­tains that the de­vice is safe for a ma­jor­ity of women and that pulling the de­vice would de­prive them of an im­por­tant birth-con­trol op­tion. It also says that the re­quired black box warn­ing does enough to pro­tect pa­tients.

“Af­ter sig­nif­i­cant re­view and anal­y­sis of avail­able in­for­ma­tion, we be­lieve Es­sure is safe and ef­fec­tive for many women-but also that some women ex­pe­ri­ence very se­ri­ous and some­times de­bil­i­tat­ing prob­lems,” said Deb­o­rah Kotz, an FDA spokes­woman.

Mean­while, the more than 14,000 re­ports to the agency have “not changed the FDA’s de­ter­mi­na­tion re­gard­ing the ben­e­fits and risks of Es­sure,” Kotz said. Es­sure of­fers ben­e­fits de­spite these side ef­fects, she added, not­ing that it is cur­rently the only non-in­ci­sional form of per­ma­nent birth con­trol.

Kotz said that the up­dated la­bel­ing “helps to en­sure that pa­tients are ap­pro­pri­ately in­formed of the risks” from Es­sure. “Ban­ning Es­sure would re­move the de­vice from the mar­ket for all pa­tients-and would limit the op­tions avail­able to physi­cians and pa­tients.” Natalie Hansen, a 47-yearold liv­ing in Mooresville, N.C., and a for­mer Es­sure pa­tient, is skep­ti­cal of that ap­proach.

Be­fore she was im­planted with Es­sure in 2011, Hansen re­called, her doc­tor dis­missed her queries about the risk of an al­ler­gic re­ac­tion to nickel, which Hansen knew even then that she was sen­si­tive to. And since then, she has made more than 70 doc­tor’s vis­its and en­dured sear­ing pain, de­pres­sion, cysts, se­vere bloat­ing, autoimmune symp­toms and a host of other med­i­cal prob­lems. Yet she con­sid­ers her­self lucky.

In early April, she had a hys­terec­tomy, and with it, her pain and com­pli­ca­tions have dis­ap­peared-al­most mirac­u­lously. Her sense of hu­mor, damp­ened for years by the con­stant pain, has resur­faced. “De­spite hav­ing or­gans taken out, I haven’t felt this good in years,” she said.

Hansen said that doc­tors to­day are fully aware of the risks of Es­sure, even af­ter the black box warn­ing the FDA is­sued in 2016. “Who’s hold­ing them ac­count­able to make sure they’re ac­tu­ally giv­ing this in­for­ma­tion to pa­tients?” she asked.


Ellen Han­ra­han is one of thou­sands of women al­leg­ing harm from Es­sure. Han­ra­han gave birth to her daugh­ter Leena in 2012, de­spite hav­ing the per­ma­nent ster­il­iza­tion de­vice im­planted two years ear­lier.

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