Listen to this article on Spotify, or watch it on YouTube.
Medical devices designed for weight loss offer diverse approaches to aid individuals in their weight management journey. These devices, regulated by the FDA, can serve as complements to diet and exercise or act as standalone treatments for conditions related to weight.
Restrictive Devices
Gastric Bands (Lap Bands)
Gastric bands are experiencing decreased use due to advancements in more effective weight loss procedures, coupled with the need for regular adjustments and associated complications.
Pros:
- Reversible: Adjustments, removal, or revisions are possible.
- Fewer complications: Generally, fewer issues and a shorter hospital stay than bariatric surgery.
- Gradual weight loss: Allows adjustment to new lifestyle and eating habits.
- Lower risk of nutrient deficiencies: Does not interfere with nutrient absorption.
Cons:
- Limited effectiveness: Less weight loss compared to some surgical procedures.
- Need for follow-up adjustments: Regular visits required for band tightness.
- Potential complications: Risk of slippage, erosion, infection, acid reflux, or vomiting.
Gastric Balloons
Gastric balloons offer a non-surgical option, appealing to those seeking a less invasive approach. While popular among certain individuals, their overall usage is still relatively lower than surgical procedures.
Pros:
- Non-surgical: No incisions or digestive system alterations required.
- Short procedure and recovery time: Placement takes less than 30 minutes.
- Temporary and reversible: Can be easily removed after the treatment period.
Cons:
- Temporary weight loss: Effects are generally temporary.
- Need for lifestyle changes: Sustainable weight loss requires significant lifestyle adjustments.
- Limited weight loss compared to surgery: Typically results in less weight loss than surgical options.
Electrical Stimulation Devices
Maestro Rechargeable System
The Maestro Rechargeable System, also known as the Maestro System, stands as an innovative solution in the fight against obesity. It’s an implantable neurostimulation system targeting nerves controlling hunger and digestion for effective weight loss.
While promising, the Maestro System’s popularity is relatively limited. Ongoing research aims to solidify its long-term effectiveness and safety, with availability varying across regions
Pros:
- Non-restrictive: No alteration to digestive system anatomy, allowing normal eating.
- Reversible: Can be turned off or removed.
- Customizable: Adjustable for personalized treatment.
- Potential Health Benefits: Positive effects on glycemic control and blood pressure.
Cons:
- Surgical Procedure: Requires surgery with potential risks.
- Limited Long-term Data: Ongoing research to assess sustained weight loss outcomes.
- Cost and Insurance: May be costly, and coverage varies.
Tantalus System
The Tantalus System, another implantable device, focuses on weight loss by delivering low-level electrical impulses to the stomach to regulate stomach contractions and delay gastric emptying.
Approved by the FDA since 2007, is not widely available. Limited centers in the United States and Europe offer this procedure, and it’s not as commonly utilized as other weight loss interventions.
Pros:
- Non-restrictive: No need for digestive system alterations or dietary restrictions.
- Reversible: Can be turned off or removed.
Cons:
- Surgical Procedure: Requires surgery with potential risks.
- Limited Long-term Data: Ongoing research for sustained weight loss outcomes.
- Cost and Insurance: May be costly, and coverage varies.
Aspiration Devices
AspireAssist System
The AspireAssist System is an intragastric aspiration device designed to assist individuals in achieving weight loss. Its mechanism involves removing a portion of ingested food from the stomach before full digestion and absorption.
A small tube is inserted into the stomach through a minimally invasive procedure. Connected to the tube, an external port discreetly resides on the abdomen. After a meal, the individual attaches a handheld device to the port, opens the valve, and aspirates stomach contents into a bag.
While the AspireAssist System is currently discontinued, it garnered attention as a weight loss option during its active period.
Pros:
- Customizable: Allows personalized therapy tailored to individual weight loss goals.
- Reversible: The device can be removed if desired.
Cons:
- Psychological Considerations: Requires commitment to lifestyle changes and behavioral modifications, posing challenges for some individuals.
- Dietary Considerations: Adherence to a specific eating and drinking protocol is essential for safe and effective use.
- Limited Long-term Data: The long-term effectiveness and safety need further study for comprehensive evaluation.
- Limited Weight Loss Compared to Surgery: Typically results in less weight loss compared to surgical procedures like gastric bypass or sleeve gastrectomy.
Common Hurdles with Medical Devices
Implanted medical devices, while offering valuable solutions, may encounter several common issues:
- Infection: Infections, caused by bacteria or microorganisms, can occur during or after the implantation process, leading to severe complications if left untreated.
- Device Malfunction or Failure: Wear and tear, damage, or manufacturing defects may cause implantable medical devices to malfunction or fail, necessitating additional surgeries or procedures.
- Migration or Displacement: Changes in the body or movement can lead to the migration or displacement of medical devices from their intended location, requiring corrective measures.
- Pain or Discomfort: Chronic pain or discomfort may arise from factors like device size, location, or the body’s reaction, impacting patients during or after the implantation procedure.
- Allergic Reactions: Some patients may experience allergic reactions to the materials used in the implantable medical device, resulting in symptoms like itching, redness, or swelling at the implantation site.
Understanding the Shift in Popularity
Several factors contribute to the decline in popularity of medical devices for weight loss compared to surgeries or medications.
- Weight Loss Surgeries: Although more invasive, surgeries like gastric bypass or gastric sleeve offer higher effectiveness, with an average weight loss of 50% or more of excess body weight and improvements in weight-related health conditions.
- Weight Loss Medications: Newer medications, despite potential side effects, have shown effectiveness comparable to surgeries in suppressing appetite or blocking fat absorption, providing significant weight loss and health improvements without surgery.
In contrast, medical devices for weight loss may be less effective, leading to more modest weight loss and potential complications like infection or device malfunction. Insurance coverage limitations may also impact their appeal.
It’s evident that medical devices alone do not provide a comprehensive solution to obesity. We need to recognize obesity as a complex issue involving genetic, hormonal, and psychological factors.
Understand that relying solely on expensive tools and surgeries is an idealized notion. While medical devices offer support, a balanced approach remains the most cost-effective and realistic strategy in the battle against obesity.
Learn more about
- Lap Band / Gastric Band for Weight Loss
- Gastric balloon for weight loss
- Gastric Sleeve vs Gastric Bypass
- Other weight loss procedures
Citations
Aarts EO, Dogan K, Koehestanie P, Janssen IM, Berends FJ. What happens after gastric band removal without additional bariatric surgery?. Surg Obes Relat Dis. 2014;10(6):1092-1096. doi:10.1016/j.soard.2013.10.014
AspireAssist Clinician Guide: https://www.accessdata.fda.gov/cdrh_docs/pdf15/p150024d.pdf
AspireAssist Patient Guide: https://static1.squarespace.com/static/620d206fc502122de782c2e1/t/620d225ec0997d18450ba7ce/1645027935038/Patient+Guide+IFU-031.pdf
Borbély Y, Winkler C, Kröll D, Nett P. Pouch Reshaping for Significant Weight Regain after Roux-en-Y Gastric Bypass. Obes Surg. 2017;27(2):439-444. doi:10.1007/s11695-016-2329-3
Cawley J, Meyerhoefer C. The medical care costs of obesity: an instrumental variables approach. J Health Econ. 2012;31(1):219-230. doi:10.1016/j.jhealeco.2011.10.003
Cooper TC, Simmons EB, Webb K, Burns JL, Kushner RF. Trends in Weight Regain Following Roux-en-Y Gastric Bypass (RYGB) Bariatric Surgery. Obes Surg. 2015;25(8):1474-1481. doi:10.1007/s11695-014-1560-z
Dietary Supplements for Weight Loss. ODS. https://ods.od.nih.gov/factsheets/WeightLoss-HealthProfessional/
Disease of Obesity. ASMBS. https://asmbs.org/patients/disease-of-obesity
Doble B, Wordsworth S, Rogers CA, et al. What Are the Real Procedural Costs of Bariatric Surgery? A Systematic Literature Review of Published Cost Analyses [published correction appears in Obes Surg. 2017 Aug;27(8):2193]. Obes Surg. 2017;27(8):2179-2192. doi:10.1007/s11695-017-2749-8
English WJ, DeMaria EJ, Hutter MM, et al. American Society for Metabolic and Bariatric Surgery 2018 estimate of metabolic and bariatric procedures performed in the United States. Surg Obes Relat Dis. 2020;16(4):457-463. doi:10.1016/j.soard.2019.12.022
Estimate of Bariatric Surgery Numbers, 2011-2019. ASMBS. https://asmbs.org/resources/estimate-of-bariatric-surgery-numbers
FDA approves AspireAssist obesity device. FDA. https://www.fda.gov/news-events/press-announcements/fda-approves-aspireassist-obesity-device
Funding by state. Division of Nutrition, Physical Activity, and Obesity. https://www.cdc.gov/nccdphp/dnpao/state-local-programs/funding.html
Funding FY20. Division of Nutrition Physical Activity and Obesity. https://www.tfah.org/wp-content/uploads/2019/02/FY20-DNPAO.pdf
King WC, Hinerman AS, Courcoulas AP. Weight regain after bariatric surgery: a systematic literature review and comparison across studies using a large reference sample. Surg Obes Relat Dis. 2020;16(8):1133-1144. doi:10.1016/j.soard.2020.03.034
Madura JA 2nd, Dibaise JK. Quick fix or long-term cure? Pros and cons of bariatric surgery. F1000 Med Rep. 2012;4:19. doi:10.3410/M4-19
Magro DO, Geloneze B, Delfini R, Pareja BC, Callejas F, Pareja JC. Long-term weight regain after gastric bypass: a 5-year prospective study. Obes Surg. 2008;18(6):648-651. doi:10.1007/s11695-007-9265-1
Maleckas A, Gudaitytė R, Petereit R, Venclauskas L, Veličkienė D. Weight regain after gastric bypass: etiology and treatment options. Gland Surg. 2016;5(6):617-624. doi:10.21037/gs.2016.12.02
Monaco-Ferreira DV, Leandro-Merhi VA. Weight Regain 10 Years After Roux-en-Y Gastric Bypass. Obes Surg. 2017;27(5):1137-1144. doi:10.1007/s11695-016-2426-3
Nyström M, Machytka E, Norén E, et al. Aspiration Therapy As a Tool to Treat Obesity: 1- to 4-Year Results in a 201-Patient Multi-Center Post-Market European Registry Study. Obes Surg. 2018;28(7):1860-1868. doi:10.1007/s11695-017-3096-5
O’Brien PE, Dixon JB. Lap-band: outcomes and results. J Laparoendosc Adv Surg Tech A. 2003;13(4):265-270. doi:10.1089/109264203322333593
Rohner A, Widmer JD, Klasen J, Scheiwiller A, Muller D, Muller MK. Long-term outcomes of gastric band removal without additional bariatric surgery. Surg Obes Relat Dis. 2017;13(2):261-266. doi:10.1016/j.soard.2016.09.010
Santo MA, Riccioppo D, Pajecki D, et al. Weight Regain After Gastric Bypass: Influence of Gut Hormones. Obes Surg. 2016;26(5):919-925. doi:10.1007/s11695-015-1908-z
Sullivan S. Aspiration Therapy for Obesity. Gastrointest Endosc Clin N Am. 2017;27(2):277-288. doi:10.1016/j.giec.2016.12.001
Suter M, Calmes JM, Paroz A, Giusti V. A 10-year experience with laparoscopic gastric banding for morbid obesity: high long-term complication and failure rates. Obes Surg. 2006;16(7):829-835. doi:10.1381/096089206777822359
The AspireAssist. Your Practice Online. https://www.ypo.education/bariatrics/the-aspireassist-t318/video/
Thompson CC, Abu Dayyeh BK, Kushnir V, et al. Aspiration therapy for the treatment of obesity: 4-year results of a multicenter randomized controlled trial. Surg Obes Relat Dis. 2019;15(8):1348-1354. doi:10.1016/j.soard.2019.04.026
Velapati SR, Shah M, Kuchkuntla AR, et al. Weight Regain After Bariatric Surgery: Prevalence, Etiology, and Treatment. Curr Nutr Rep. 2018;7(4):329-334. doi:10.1007/s13668-018-0243-0
Weight-Loss Devices. FDA. https://www.fda.gov/medical-devices/products-and-medical-procedures/weight-loss-and-weight-management-devices#loss
Weiner JP, Goodwin SM, Chang H, et al. Impact of Bariatric Surgery on Health Care Costs of Obese Persons: A 6-Year Follow-up of Surgical and Comparison Cohorts Using Health Plan Data. JAMA Surg. 2013;148(6):555–561. doi:10.1001/jamasurg.2013.1504
Attributions
YouTube: AspireAssist Weight Loss Procedure. www.aspirebariatrics.com
See also
- Akkermansia Muciniphila for Weight LossAkkermansia Muciniphila may lower obesity risks and improve cardiovascular health, but evidence for weight loss is weak.
- Comparing Different Gastric BalloonsMany types of gastric balloons exist, from swallowable to adjustable, although the standard Orbera balloon remains the most commonly used.
- Gastric Balloon Diet PlanOnce you have a gastric balloon, properly transitioning from liquids on day 1 to 3, to solids by day 14, is key to success on your balloon.
- The Allurion gastric balloonThe Allurion is a swallowable gastric balloon that naturally passes into the stools itself. However, it is smaller than the Orbera balloon.
- How to Choose a Diet for Weight LossCICO, low carb, keto, high protein, and intermittent fasting are all good beginner diets. However you should modify them to fit your needs.