Bariatric surgeries, including gastric bypass, gastric banding, and gastric
balloon placement, are among the fastest growing surgical procedures.
While the surgeries have proven successful in helping patients lose weight,
complications are not uncommon and can be life threatening if not properly
diagnosed and treated.
FDA Investigating Gastric Balloons
As San Diego injury attorneys, we are increasingly concerned about the
safety of gastric balloons. The medical devices are currently linked to
the deaths of five patients.
described by the FDA, gastric balloons are temporary devices intended to help treat obesity.
They typically include one, two, or three balloons that fill space in
the stomach. They can be placed via a swallowable capsule attached to
a thin catheter or via an endoscope (a long flexible tube with a small
camera and light at the end). After the device is placed, it is filled
with gas or saline. Balloons filled with saline are then sealed, and all
balloons must be removed after six months.
Implanting a gastric balloon is touted as minimally invasive and effective
weight-loss procedure. However, according to a
recent alert by the U.S. Drug and Food Administration (FDA), the new medical devices may pose serious risks. The agency is currently
investigating five reports of unanticipated deaths that occurred from
2016 to present in patients with liquid-filled intragastric balloon systems.
Four reports involve the Orbera Intragastric Balloon System, manufactured
by Apollo Endo Surgery, and one report involves the ReShape Integrated
Dual Balloon System, manufactured by ReShape Medical Inc.
According to the FDA, the patients all died within a month or less of balloon
placement. In three reports, death occurred as soon as one to three days
after balloon placement. The agency is investigating whether the medical
devices are defective or whether the insertion procedures for the gastric
balloons may have caused the patients' deaths, such as gastric and
esophageal perforation or intestinal obstruction.
The FDA disclosed that it has received two additional reports of patient
death linked to potential complications associated with balloon treatment.
In one case, a patient implanted with the Orbera balloon system suffered
a gastric perforation. In the other, a patient with the ReShape balloon
system implanted suffered an esophageal perforation.
Alarming, this is not the first time the FDA has raised concerns about
the safety of gastric balloons. In February, the agency issued a letter
to health care providers to recommend close monitoring of patients with
liquid-filled intragastric balloon systems for the potential risks of
acute pancreatitis and spontaneous over-inflation. In the wake of the
letter, both device makers revised their product labeling to address these risks.
Medical Malpractice Suits Involving Elective Surgery
Unfortunately, gastric balloons are not the only gastric devices raising
safety concerns. Surgeons are performing fewer gastric band surgeries,
in large part because patients often suffer complications that require
additional procedures. Complications can occur when the medical device
erodes into the stomach or causes obstruction by slipping down. One recent
study found that one in five patients needed additional surgeries within
about five years of receiving a gastric band.
When something goes wrong with weight-loss procedures, patients often wonder
if they can
pursue a medical malpractice lawsuit for harm suffered in conjunction with an elective surgery. The short answer
is yes. If a medical professional deviates from the accepted standard
of care and injures a patient during an elective cosmetic procedure, he
or she can be held accountable in a California medical malpractice lawsuit.
Of course, not all mistakes rise to the level of elective surgery malpractice.
The threshold question is whether the medical professional acted in a
way other medical professionals under the same or similar circumstances
would have acted. In addition, dissatisfaction with the results of an
elective surgery is generally not grounds for a malpractice lawsuit.
Patients whose bariatric surgery involved a medical device, such as a gastric
balloon or lap band, may also have a claim against the manufacturer. In
many cases, complications following weight loss surgeries are linked to
If you or someone you love has suffered harm due to a medical error or
defective medical product, don't hesitate to contact
a San Diego injury attorney at the Law Offices of Robert Vaage for a free consultation.