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A third intragastric balloon has hit the market with the FDA’s recent approval of the Obalon Balloon system.

This news will undoubtedly increase the number of questions from patients who are now being exposed to manufacturers’ messages claiming these as effective non-surgical weight loss solutions for people with BMIs of 30-40.

Are you ready?

Communicate, Communicate, Communicate
With three distinctly different balloons on the market, it’s important to educate patients on all three devices. If you have elected to go with one brand exclusively, that needs to be clearly explained to the patient, along with the rationale for your decision.

Dr. George Merriman, a member of the PhysicianProtect™ | BARIATRIC Medical Malpractice Program has successfully placed both the ReShape® double balloon and the Orbera™single balloon systems. “When coupled with medication, patients who have opted for this procedure have had positive results – with 10%-20% total body weight loss expected,” he says. However, Dr. Merriman warns that this procedure is not appropriate for everyone. “Expertise in managing the medication side of the equation is extremely important, as is taking into consideration the unique factors contributing to a patient’s obesity.”

5 Risk Tips
Here are five things to consider in managing the risk of introducing new gastric balloons into your practice:

  1. Patient Selection. Develop and formalize appropriate patient-selection criteria.
  2. Medication Expertise. If you plan to develop a program to include a regimen of medications for weight, be sure to partner with a physician who is experienced in prescribing that medication or be able to demonstrate that you have received training and are competent to manage diet medications.
  3. Informed Consent. Develop procedure-specific informed consent forms utilizing risk-benefit analysis specific to the brand of balloon you are using.
  4. Informed Consent #2. Have patients sign a separate informed consent form prior to placement to document an understanding of the need to have the device removed in six months, including the consequences and risks of not maintaining follow-up to have the device removed. Document missed appointments.
  5. Long-Term Support. Invest in resources to support patient lifestyle changes that must be made to significantly change behavior in sustaining weight loss after the balloon is removed.

One of the advantages of the PhysicianProtect™ | BARIATRIC Medical Malpractice Program is access to experienced bariatric practice-specific risk management people and tools.

For more information, questions, or comments, contact amanda@omnisure.com or 512-645-8891.



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