Deaths may be linked to gas­tric de­vice

FDA looks at sev­eral cases of weight-loss pa­tients dy­ing af­ter in­ser­tion of bal­loon.

Los Angeles Times - - THE NATION - By Melissa Healy melissa.healy@la­ Twit­ter: @LATMelis­saHealy

The U.S. Food and Drug Ad­min­is­tra­tion has alerted physi­cians who treat obe­sity that it is in­ves­ti­gat­ing whether there is a link be­tween gas­tric bal­loons — new-gen­er­a­tion weight-loss de­vices — and the deaths of five pa­tients.

In an alert is­sued Thurs­day, the FDA said that from 2016 to the present, five “unan­tic­i­pated deaths” had oc­curred in pa­tients a month or less af­ter hav­ing liq­uid-filled gas­tric bal­loon sys­tems im­planted in their stom­achs. In three of the cases, the agency said pa­tients died be­tween one and three days af­ter the weight­loss de­vice had been put in place.

“At this time, we do not know the root cause or in­ci­dence rate of pa­tient death, nor have we been able to defini­tively at­tribute the deaths to the de­vices or the in­ser­tion pro­ce­dures for th­ese de­vices,” the FDA told physi­cians.

The agency sug­gested it would ex­plore the pos­si­bil­ity that pa­tients suf­fered gas­tric and esophageal per­fo­ra­tion or in­testi­nal ob­struc­tion, ei­ther while the de­vice was be­ing im­planted or after­ward.

Four of the deaths in­volved the Or­bera In­tra­gas­tric Bal­loon Sys­tem, man­u­fac­tured by Apollo En­do­surgery and ap­proved by the FDA in Au­gust 2015. One re­port in­volved the ReShape In­te­grated Dual Bal­loon Sys­tem, made by ReShape Med­i­cal Inc. in San Cle­mente and ap­proved by the FDA in July 2015.

The agency said it had re­ceived re­ports of two other deaths since 2016 re­lated to po­ten­tial com­pli­ca­tions as­so­ci­ated with bal­loon treat­ment. In one of those, a pa­tient who had the Or­bera bal­loon sys­tem im­planted suf­fered a gas­tric per­fo­ra­tion. In the sec­ond death, a pa­tient who got the ReShape bal­loon sys­tem suf­fered an esophageal per­fo­ra­tion.

Apollo En­do­surgery said in a state­ment re­leased Thurs­day that the com­pany had re­ported all five cases re­lated to its prod­uct to the FDA. The com­pany said it had “not re­ceived any com­mu­ni­ca­tion or in­di­ca­tion from the at­tend­ing physi­cians or hos­pi­tals that the deaths have been due” to the Or­bera de­vices. The state­ment added that the com­pany “has re­ceived no prod­uct li­a­bil­ity-re­lated claims in con­nec­tion with th­ese five cases.”

Rep­re­sen­ta­tives of ReShape Med­i­cal Inc. could not be reached for com­ment.

The FDA’s new scru­tiny of the weight-loss de­vices fol­lows ear­lier safety con­cerns con­veyed to health­care providers.

In Fe­bru­ary, the agency warned that it had re­ceived re­ports of ad­verse events in which liq­uid-filled gas­tric bal­loons in pa­tients’ stom­achs over­in­flated with air or liq­uid — a phe­nom­e­non it called spon­ta­neous hy­per­in­fla­tion. The prob­lem re­quired re­moval of the de­vice ahead of sched­ule.

The agency also said it had re­ceived re­ports that pa­tients get­ting the de­vices de­vel­oped acute pan­cre­ati­tis, which also re­sulted in the need for early re­moval of the bal­loons.

Stan­ford bariatric sur­geon John Mor­ton, who has im­planted roughly 70 of the ReShape de­vices, said he had not seen com­pli­ca­tions in his pa­tients, who typ­i­cally have lost weight with the de­vices.

“Ev­ery death is a tragedy, and has to be in­ves­ti­gated,” said Mor­ton, who is a past pres­i­dent of the Amer­i­can So­ci­ety for Metabolic and Bariatric Surgery. But as de­vices used for pa­tients at rel­a­tively low lev­els of obe­sity, and which pro­mote rel­a­tively mod­est weight loss, the stan­dard of safety they should meet is par­tic­u­larly high, he added.

Both the ReShape and Or­bera sys­tems are ap­proved for pa­tients with a body mass in­dex, or BMI, be­tween 30 and 40. They gen­er­ally are con­sid­ered a less-in­va­sive and less­costly al­ter­na­tive to bariatric surgery for pa­tients who are less obese or can­not tol­er­ate per­ma­nent sur­gi­cal al­ter­ation of their gas­troin­testi­nal tract.

“I can only spec­u­late this is likely to do with tech­nique,” Mor­ton said. “There’s skill in­volved in the place­ment of th­ese bal­loons. Who places them makes a dif­fer­ence. If you’re an ex­pe­ri­enced en­do­scopist and sur­geon, you rec­og­nize the signs of per­fo­ra­tion, which is im­por­tant be­cause they’re treat­able.”

Gas­tric bal­loons are de­liv­ered into the stom­ach via the mouth in an out­pa­tient pro­ce­dure con­sid­ered min­i­mally in­va­sive. The pro­ce­dure gen­er­ally takes less than 30 min­utes, dur­ing which a pa­tient is un­der mild se­da­tion. The de­vices are de­signed to be in place for six months.

Once in place, the bal­loon is in­flated with a ster­ile so­lu­tion, which takes up room in the stom­ach. While nau­sea and stom­ach dis­com­fort are ex­pected in the days im­me­di­ately fol­low­ing the pro­ce­dure, those symp­toms typ­i­cally abate. While the de­vices are in place, pa­tients who get them are ex­pected to feel less hun­gry and typ­i­cally re­port los­ing 5% to 10% of their weight.

Apollo’s web­site says that more than 220,000 peo­ple world­wide have had its weight-loss bal­loons im­planted. In­ter­na­tional sales of gas­tric bal­loons were es­ti­mated to to­tal about $120 mil­lion in 2015, driven by broad use in Brazil, Mex­ico and Europe.

But Mor­ton said man­u­fac­tur­ers re­port that only about 5,000 gas­tric bal­loons have been im­planted in the United States. The Amer­i­can So­ci­ety for Metabolic and Bariatric Surgery says fa­cil­i­ties it has ac­cred­ited to per­form the pro­ce­dures have im­planted about 1,000 of the de­vices, and re­cently re­ported they have seen no deaths be­cause of com­pli­ca­tions.

“Th­ese de­vices need to be placed in cen­ters that have ad­e­quate fol­low-up, the re­sources to pro­vide that fol­low-up and the ex­pe­ri­ence to rec­og­nize th­ese com­pli­ca­tions,” Mor­ton said.

The FDA said Thurs­day that it “con­tin­ues to work with Apollo En­do­surgery and ReShape Med­i­cal Inc. to bet­ter un­der­stand the is­sue of unan­tic­i­pated death, and to mon­i­tor the po­ten­tial com­pli­ca­tions of acute pan­cre­ati­tis and spon­ta­neous over­in­fla­tion.”

The agency said it would in­form the pub­lic when it has more in­for­ma­tion. In the mean­time, of­fi­cials said that “pa­tients should speak to their doc­tors to de­ter­mine which obe­sity treat­ment op­tion is best for them.”

M. Spencer Green As­so­ci­ated Press

GAS­TRIC BAL­LOONS for weight loss can be in­serted fairly quickly, but have raised var­i­ous safety con­cerns.

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