February 1, 2023

Tenet: FDA approves new weight-loss option

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logo-1562-1700New FDA approves new weight-loss option – promises significant benefits to Caribbean patients who want to lose weight without surgical intervention.

The U.S. Food and Drug Administration has approved a new balloon device to treat obesity without the need for invasive surgery; which could provide significant benefits for many patients in the Caribbean struggling with weight issues and prefer a non-surgical option.

The ReShape Integrated Dual Balloon System (ReShape Dual Balloon) is intended to facilitate weight loss in obese adult patients. The device likely works by occupying space in the stomach, which may trigger feelings of fullness, or by other mechanisms that are not yet understood.

“For those with obesity, significant weight loss and maintenance of that weight loss often requires a combination of solutions including efforts to improve diet and exercise habits,” said William Maisel, M.D., M.P.H., acting director of the Office of Device Evaluation at the FDA’s Center for Devices and Radiological Health. “This new balloon device provides doctors and patients with a new non-surgical option that can be quickly implanted, is non-permanent, and can be easily removed.”

Dr. Fernando Bayron of Tenet Florida Physician Services (TFPS) is now offering the ReShape™ integrated dual balloon system, a non-surgical and proven weight-loss procedure approved by the Food and Drug Administration (FDA).  To qualify for the procedure, patients must be adults with a body mass index (BMI) between 30-40 and a condition or disorder which accompanies obesity. Dr. Bayron is one of only three bariatric surgeons in South Florida currently offering this temporary and minimally invasive weight-loss option.

The balloon system is available to patients who haven’t succeeded at diet and exercise alone or who do not want, or qualify for bariatric surgery. During a brief outpatient procedure, Dr. Bayron endoscopically inserts the balloons into the stomach of a patient, who is comfortably sedated under light anesthesia. Six months later, Dr. Bayron deflates the device and removes the balloons from the patient’s stomach.

“The dual balloon system procedure is different from other weight-loss procedures because it’s a non-surgical option for patients. It gives them a low-risk alternative for weight-loss. This is a new tool in the fight against obesity,” said Dr. Bayron, a general surgeon certified by the American Board of General Surgery and specialist in bariatric surgery.

By inserting the two saline-filled balloons, made from medical grade silicone, into the stomach for six months, Dr. Bayron creates a short-term, built-in portion control system. He said patients can still eat the healthy foods they enjoy while the balloons help the patients to feel full and less hungry. The connected balloons conform to the natural shape of the stomach. After insertion of the balloons, Dr. Bayron is part of a team providing one-year of comprehensive coaching on a jump start to healthy living. Patients participate in 12 months of medically-supervised nutrition and exercise coaching to help enable sustained weight-loss.

For more information on this non-surgical option of weight loss, treatments and procedures, email: [email protected] or call toll-free – 1-855-836-3846

About Tenet Florida International:

 With its close proximity and world-class healthcare, south Florida has been a preferred destination for patients from the Caribbean and Latin America seeking healthcare outside of their borders. As one of the largest healthcare networks in south Florida, Tenet Florida hospitals and outpatient centers are swiftly becoming a favored choice for health services by international patients. Tenet Florida comprises nine acute care hospitals with ten sites of service throughout Palm Beach, Broward and Miami-Dade Counties.

Tenet Florida Hospitals’ specialized centers of excellence include:

  • 2 major trauma hospitals (Level I)
  • 1 pediatric hospital
  • 6 bariatric centers
  • 5 cardiac centers
  • 10 orthopedic hospitals
  • 3 NICU centers – level III (highest certification)
  • 4 oncology centers
  • 10 comprehensive & primary stroke centers
  • 1 pediatric cardiology center
  • 1 pediatric neurosurgery center
  • 1 gamma knife center

Together, the nine hospitals with ten sites of service provide some of the most comprehensive, specialized medical, surgical and outpatient services in a single healthcare network. From the routine to the most challenging cases, Tenet Florida hospitals and outpatient centers have a strong reputation for delivering high quality healthcare and outstanding customer service. For more information on Tenet’s International program please email our team at [email protected]


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