reshape procedure reference guide · • no raw fruits and vegetables, coarse breads and cereals,...

ReShape® Procedure Reference Guide

ReShape™. The Non-Surgical Weight Loss Procedure.

NOTE: This guide does not replace the Instructions For Use (IFU) and should be used in combination with the IFUs supplied with the products.

Read

iness Evaluation

Your personalized screening and medical evaluation

The first six months combines balloons with comprehensive coaching

A second six months of personalized support to continue your success

Evaluation

Visit 1: Consultation

Visit 2: Clinic Visit

Readiness EvaluationEvaluate and educate to prepare each individual for success.

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Baseline Assessment

• Screen and assess prior to first visit

• Educate patient on what to expect

• Review patient qualifications

Visit 1: Consultation

• Assess patient’s level of commitment

• Evaluate patient’s needs and goals

• Set expectations

• Review risks and complications

• Optional: administer general psychological evaluation

• Review pre-procedure history and conduct physical exam

• Document current medications

• Determine if patient is qualified for procedure

• Schedule procedure date

Visit 2: Pre-procedure Prep

• Review post-insertion medications

• Review pre- and post-insertion instructions

• Review schedule of visits/coaching sessions

• Review Patient Guide Book

• Register patient on Patient Portal

• Conduct initial coaching session or connect patient with coach

• Call patient two days prior to procedure to review instructions

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Med

ications

Purpose Name Directions

Proton Pump Inhibitor (PPI)

e.g. Omeprazole

Must be started at least three days prior to insertion and taken every day until balloon removal

Antispasmodics e.g. Levsin (Hyoscyamine)

Prescribed for use immediately post-insertion and PRN

Antiemetics/ Anti-nausea

e.g. Reglan, Zofran, Phenergan

Anti-anxiety e.g. Ativan (Lorazepam)

Pain reliever e.g. Lortab

Prohibited Medications

Patient’s PCP should determine if patient can be off of the prohibited medications for the duration of the balloon placement: • Anticoagulants • Chronic oral, injectable, or inhaled steroids • Chronic aspirin over 81 mg/day • Chronic NSAIDs • Other medications known to be gastric irritants or to reduce GI motility

MedicationsA patient who is supplied with and educated on these medications will be better prepared to handle the most common side effects.

The medications listed are guidelines only. Physicians should choose the appropriate medications for patient.

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Dietary GuidelinesPre-insertion Diet

Pre-insertion diet

48 hours prior • Eat only soft foods or easily digested foods such as milk, fruit juices, eggs, cheese, custards, puddings, strained soups, cooked vegetables, rice, baked potatoes, and breads

• No raw fruits and vegetables, coarse breads and cereals, rich desserts or fried foods

• Meat in any form is prohibited; eggs, liquid protein supplements, and tofu are allowed

24 hours prior • Clear liquids only such as juice, clear broth, tea, Jell-O and popsicles

• No food in any form

12 hours prior • No food or liquid of any form • Stomach should be empty before procedure

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Post-insertion Diet Instructions: Days 1-3

Days 1-3: Clear Liquid Diet

Suggestions Instructions

• Clear broth

• Jell-O

• Ice chips

• Small sips of water

• Diluted juices

• Sports drinks

• Herbal and decaf tea

• Popsicles

• Avoid carbonated drinks, coffee, and alcohol

• Drink small sips

• Try warm fluids

• Stay hydrated

Patients will need to follow a specialized, progressive diet immediately following the procedure, so it is equally important to review the post-insertion diet at this visit.

The dietary guidelines are outlined in this chart and can also be found in the Patient Guide Book.

Please instruct to avoid carbonated beverages, as well as caffeine and alcohol. The dietary goal for the first few days following the procedure is to stay hydrated

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Post-insertion Diet Instructions: Days 4-7

Days 4-7: Smooth, Puréed Food


• Liquid protein supplements and smoothies

• Skim or 1% milk • Yogurt (without chunks of fruit)

• Puréed fruit • Soft cooked and puréed vegetables

• Soups (strained or blended)

• Cream of wheat or oatmeal, thinned

• Sugar-free pudding

• Eat food and sip liquids very slowly and stop eating at first sign of fullness; portion sizes may vary from two tablespoons to one cup of food per meal

• Aim for five small puréed meals per day

• Stay hydrated and drink water 30 minutes after each meal

Beginning days 4-7, the patient will need to transition to a smooth or puréed diet. This should begin after all signs of nausea have passed. Many patients prefer liquid protein supplements for ease of use along with yogurt, puréed fruit, strained soups, and soft cooked vegetables.

It is important to counsel the patient to chew food thoroughly, eat very slowly, and stop eating or drinking at first sign of fullness. If they are not tolerating solid foods after 10 days, they should call your office or check in with the dietitian. Focusing on liquids is still important in this phase.

Dietary Guidelines (continued)

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Post-insertion Diet Instructions: Days 8 and Beyond

Days 8-10: Soft Foods


• Tofu • Soft, poached fish • Lean ground meats • Deli meats, thinly sliced • Canned tuna packed in water • Canned chicken packed in broth

• Scrambled eggs • Cottage cheese • Toast • Well-cooked vegetables • Soft fruit with skin removed

• Chew food thoroughly

• Eat very slowly and stop eating at first sign of fullness; portion sizes will vary

• Avoid eating and drinking at the same time

• Stay hydrated and drink water 30 minutes after every meal

Beginning days 8 and beyond, the patient will need to transition to a soft and then a regular diet. Emphasize eating slowly and stop eating at the first sign of fullness. Portion sizes will vary for each patient and with each meal as the stomach volume will be smaller after balloon placement. Meals during the first month may only consist of a few bites. We’ve also included a sample soft foods menu in the Patient Guide Book to help guide them.

Please counsel the patient to limit or eliminate liquid calories such as juice or liquid protein supplements after this phase as they do not provide a sense of satiety and may increase hunger symptoms overall. Once they have completed the diet progression, it is important to transition to protein and fiber rich foods for each meal.

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Soft Foods Sample MenuDays 8-10: Soft Diet Sample Menu*

Breakfast

• ¼ cup of soft fruit such as banana or melon • 1 scrambled egg • ¼ cup skim milk

Mid-morning Snack

• ¼ cup of sugar-free pudding or liquid protein drink

Lunch

• ¼ cup canned chicken or tuna prepared with 1 tablespoon low-fat mayo

• ½ piece toast • ¼ cup mango

Mid-afternoon Snack

• ½ cup non-fat yogurt

Dinner

• 2 ounces soft, poached fish or ¼ cup lean ground turkey

• ¼ cup steamed zucchini squash or carrots • ¼ cup cottage cheese

*Portion sizes will vary. It’s important to not overeat and to stop eating at first sign of fullness.

The Patient Guide Book shows a sample menu for convenience during this time


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Pre-removal Diet

Pre-removal Diet

48 hours prior • Only soft or easily digested foods such as milk, fruit juices, eggs, cheese, custards, puddings, strained soups, cooked vegetables, rice, baked potatoes, and breads

• No raw fruits and vegetables, coarse breads and cereals, rich desserts or fried foods

• Meat in any form is prohibited; eggs, liquid protein supplements, and tofu are allowed

24 hours prior • Clear liquids only • No food in any form

12 hours prior • No food or liquid of any form • Stomach should be empty before procedure

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Additional Dietary RecommendationsPortion Sizes

• Recommended portion sizes will vary per patient as stomach volume will be smaller after dual balloon placement. Meals during the first few months may only consist of a few bites.

• When transitioning from liquid to solid foods, patients should be encouraged to chew thoroughly, eat slowly, and to stop eating at first sign of fullness.

• Monitor and address portion sizes at each coaching session for continued weight loss throughout the program.

Fluids

• Water should be consumed 30-45 minutes after the meal. This will encourage hydration and prevent constipation. Encourage small, frequent sips throughout the day.

• Advise patients to limit consumption of liquid calories after the clear liquid diet phase as they do not provide a sense of satiety. This includes continued use of liquid protein supplements after the first few weeks following implantation. Once patients have completed the diet progression they should transition to protein-rich solid foods instead.

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Vitamin Mineral Supplementation

• While there are no specific vitamin and mineral supplementation requirements during the balloon implant period, if vitamin mineral supplements are prescribed, a chewable supplement might be beneficial to avoid gastric irritation.

Note: For diet related questions please contact [email protected]

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Dietary Guidelines (continued)Are They Still Hungry? Discuss Mindful Eating Techniques

Many people who have the ReShape® Procedure struggle with food and react mindlessly to food triggers. Mindful eating is much more than “eating slowly, without distraction.” While that’s important, many times food triggers and feelings we identify as hunger, isn’t hunger at all.

For example, when a patient feels hungry, instead of reacting to the hunger and mindlessly eating the food, coach the patient to pause and ask the question, “Am I physically hungry?”

Mindful eating empowers patients to finally break old automatic eating habits like eating from boredom, stress or while watching TV and discover strategies that work better for them.

Step 1. Stop and ask “Am I physically hungry?”

Step 2. If yes, eat something nourishing.

Step 3. If no, identify and explore where the hunger is coming from. Is it…

• Head Hunger —“It’s Noon and must be time to eat”

• Eye Hunger—“Wow! That looks so delicious!”

• Nose Hunger—“Ah, I want that food, it smells so good”

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• Mouth Hunger—“I just need something to chew”

• Heart Hunger—“Eating this will make me feel better”

Step 4. Resolve the true source of the hunger and ask…

• What do I really need?

• What can I do instead? Leave the room. Go for a walk. Talk to a friend.

• Remember, it’s not all about food. No amount of food will make them feel better if they are eating from stress or to cure boredom. Only by recognizing the non-food triggers or the true source of their hunger and learning to meet their other needs in more effective ways will they stop the overeating cycle and feel better.

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Risks and

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Nausea, Vomiting, Abdominal Pain & Discomfort

• Most patients will experience some degree of nausea, vomiting, abdominal pain and discomfort

• For some patients, symptoms subside quickly; for others they last longer

• Symptoms usually resolve within the first 30 days

Treatment

• Most symptoms can be treated with prescribed medications and in some cases IV hydration may be necessary

• In more severe cases, patients may opt for early balloon removal

• Educate and encourage patients to call you or return to the clinic for treatment rather than go to the ER

Risks and ComplicationsReview known adverse events (AEs) and complications with patient.

Most AEs can be treated by adjusting the patient’s diet, encouraging PPI usage, monitoring the prohibited meds usage, and reminding the patient to stay hydrated.

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Balloon Deflations

Detection starts with patient:• Blue-green tinted urine• Physical difference—

pay close attention to stomach sensations

• Onset or increase in AE symptoms

Confirmation through:• Ultrasound• X-ray with barium

swallow• CT scan• Endoscopy

Treatment

• Removal of balloons should be scheduled as soon as possible once deflation is confirmed

Others

• Diarrhea, constipation, change in bowel habits • GERD, heartburn, indigestion • Gas, belching, bloating • Dehydration, weakness, fatigue • Esophageal, oropharyngeal pain • Gastric ulcers, erosions

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Contraindications: • Prior gastrointestinal surgery with sequelae, i.e. obstruction, and/or adhesive peritonitis or known abdominal adhesions.

• Prior open or laparoscopic bariatric surgery.

• Any inflammatory disease of the gastrointestinal tract including esophagitis, gastric ulceration, duodenal ulceration, cancer or specific inflammation such as Crohn’s disease.

• Potential upper gastrointestinal bleeding conditions such as esophageal or gastric varices, congenital or acquired intestinal telangiectasis, or other congenital anomalies of the gastrointestinal tract such as atresias or stenoses.

• A gastric mass.

• A hiatal hernia > 5 cm or ≤ 5 cm with associated severe or intractable gastro-esophageal reflux symptoms.

• A structural abnormality in the esophagus or pharynx such as a stricture or diverticulum that could impede passage of the delivery catheter and/or an endoscope.

• Achalasia or any other severe esophageal motility disorder that may pose a safety risk during the removal of the device.

• Severe coagulopathy.

• Hepatic insufficiency or cirrhosis.

• Serious or uncontrolled psychiatric illness or disorder that could compromise patient understanding of or compliance with follow-up visits and removal of the device after 6 months.

• Alcoholism or drug addiction.

• Patients unwilling to participate in an established medically-supervised diet and behavior modification program, with routine medical follow-up.

• Patients receiving daily-prescribed treatment with aspirin, anti-inflammatory agents, anticoagulants or other gastric irritants.

• Patients who are unable or unwilling to take prescribed proton pump inhibitor medication for the duration of the device implant.

• Patients who are known to have, or suspected to have, an allergic reaction to materials contained in the system.

• Patients who have ever developed a serotonin syndrome AND are currently taking any drug known to affect the levels of serotonin in the body [e.g., selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), monoamine oxidase inhibitors (MAOIs)] should not undergo placement of the device.

• Patients who are pregnant or breast-feeding.

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Patient Instructions

Patient InstructionsCall patient to review the following instructions two days before the procedure.

Pre-insertion

Diet • Stomach must be empty before procedure

• 48 hours before: Eat only soft foods–meat in any form is prohibited

• 24 hours before: Consume only clear liquids–no food in any form

• 12 hours before: Stop all food and drink

• Failure to follow dietary guidelines may result in cancellation of the procedure

Medications • Some medications may need to be stopped in the days leading up to the procedure (e.g., blood thinners)

• Review current medications with patient and provide instructions

• Patient may need to consult with their PCP/specialist

Exclusion Criteria

• Review possible anatomic findings that can potentially disqualify patient from balloon treatment

• These endoscopic findings may be old diagnosis or new findings so thorough discussions with the patient about their medical history is important

• Other complications may occur during the procedure, so endoscopy and insertion procedure should be discussed

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Plan for Recovery

• Patient will undergo sedation that will require someone to drive them home

• Patient may need to take a few days off of work/school to get through the post-insertion symptoms

• Prescriptions should be filled prior to procedure day

Recovery

• Patient should expect to experience nausea, vomiting, and abdominal pain

• Patient should be ambulatory as soon as possible and sit in an upright position rather than recline after the procedure

• Hydration is important—small sips of warm water are better than large sips of cold water. Carbonated drinks are not recommended

• Provide instructions on prescribed medication usage for proactive management of these symptoms at home

• Patient may need to take a few days off of work/school to get through the post-insertion symptoms

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Patient Instructions

Initial Coaching Session

Plan for One Hour During Visit 2

In-office • Review Patient Guide Book • Register patient on portal • Provide an education session for the patient covering the pre- and post-insertion diet

Home Education

• Start patient on food journaling to gain perspective on their current food intake

• Prepare home and workplace for dietary changes post-insertion

• Set up the wireless scale

Goals • Develop an overall treatment plan • Prepare patient for necessary dietary and behavioral change

• Set short-term, attainable goals for diet and exercise that will be reviewed at each follow-up

• Develop a therapeutic relationship with the patient

Daily Life • Use Patient Portal to maintain food, weight, and exercise log

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Follow-up Care First 6 Months

Month 1Post-insertion Follow-up Care

Reminders • Patient needs the most care and follow-up within two weeks post-insertion

• Extra care and attention should be made to patient through phone calls, emails, and clinic visits

Day 1 • Call patient within 24 hrs post-insertion

• Call patient every few days until symptoms subside

Day 7-14

(one clinic visit)

• Patient clinic visit

• Remind patient of: • Rx meds• Alternative home therapies• Maintaining liquid diet

(progressive diet)• IV hydration therapy if necessary• Light to moderate exercise

• Check vitals

• Monitor PPI usage

• Perform physical exam

• No NSAID or prohibited meds usage

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Months 2–5Post-insertion Follow-up Care

General In-Office Procedures

• Check vitals

• Take weight


• Confirm patient isn’t taking any NSAIDs or prohibited medications

• Assess, treat, and monitor symptoms, short and long-term complications

• Month 5—Schedule removal procedure

Coaching Session

• Provide customized coaching based on patient’s progress

• Review portal dashboard

• Monitor weight and body composition

• Review dietary guidelines and assess food consumption and overall nutritional status

• Review goals

Therapy (as needed)

• Behavioral and emotional support

• One-on-one or group sessions

Labs • As needed or indicated by institutional practices

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Month 6Post-insertion Follow-up Care and Removal Prep

General In-Office Procedures

• Check vitals

• Take weight


• Confirm patient isn’t taking any NSAIDs or prohibited medications

• Assess, treat, and monitor symptoms, short, and long-term complications

Coaching Session

• Provide customized coaching based on patient’s progress

• Emphasize importance of continued behavior modification

• Monitor weight and body composition


• Review goals

Therapy (as needed)



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Balloon Removal Prep

• Review of pre- and post-insertion instructions

• Post-insertion expectations

• Review of possible complications caused by the endoscopy or removal procedures

• Schedule balloon removal if not previously scheduled

Important Reminders

• Call patient two days prior to removal to review removal instructions

• Call patient 1–2 weeks post-removal to make sure he/she is transitioning well

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Beyond 6 MonthsMonths 7–12

Post-removal Follow-up Care

Coaching Session

• Provide customized coaching based on patient’s progress• Dietary support• Exercise support

• Educational support

• Monitor weight and activity level


• Review goals

• Ongoing patient portal is available past 12 months

General In-office Procedures (as needed)

• Check vitals

• Take weight

• Assess, treat, and monitor symptoms

Therapy (as needed)



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Important ReShape Integrated Dual Balloon System Safety Information

Indications: The ReShape Integrated Dual Balloon System is indicated for weight reduction when used in conjunction with diet and exercise, in obese patients with a Body Mass Index (BMI) of 30 – 40 kg/m2 and one or more obesity-related comorbid conditions. It is indicated for use in adult patients who have failed weight reduction with diet and exercise alone. Contraindications: The ReShape Integrated Dual Balloon System is not recommended for patients with conditions that may increase the risk of poor results (e.g., prior gastrointestinal surgery with sequelae, prior open or laparoscopic bariatric surgery, inflammatory diseases of the GI tract, potential upper GI bleeding), who are unwilling to participate in an established medically supervised diet and behavior modification program, who have alcohol or drug addictions, who receive daily prescribed treatment with aspirin, anti-inflammatory agents, anticoagulants or other gastric irritants, or who currently are or may be pregnant or breast-feeding. Warnings: The maximum placement period for the ReShape Integrated Dual Balloon is 6 months. The risk of intragastric balloon deflation and intestinal obstruction (and therefore possible complications related to intestinal obstruction) is significantly higher when balloons are left in place longer than 6 months. The presence of blue-green urine or sudden loss of satiety, increased hunger and/or weight gain may be a sign of balloon deflation. Failure of patients to take prescribed daily proton-pump inhibitor medication increases the risk of gastric ulceration or perforation. Adverse Events: Placement of the ReShape Integrated Dual Balloon requires an endoscopic procedure with sedation. Potential risks associated with an endoscopic procedure and sedation include adverse reaction to sedation (headache, muscle pain, nausea), infection, pneumonia, and respiratory distress. Potential risks associated with the ReShape Integrated Dual Balloon include ulceration, perforation, abdominal pain, nausea, vomiting, bloating, belching, heartburn, dehydration, and sore throat. These complications may be severe enough to require early removal of the ReShape Integrated Dual Balloon. Although the ReShape Dual Balloon design provides an anti-migration feature, there is the potential risk of device migration and intestinal obstruction. The risk of intestinal obstruction is increased if the device is not removed after six months. If intestinal migration occurs, surgical or endoscopic removal may be required.

Important: For full safety information please talk with your doctor, or call ReShape Customer Support at 1-844-YES-RESHAPE (1-844-937-7474).

CAUTION: Rx only.

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RESHAPE and the RESHAPE MEDICAL logo are registered trademarks of ReShape Medical, Inc. All other brand/product names are trademarks of their respective owners.

© 2017 ReShape Medical, Inc. All rights reserved.04-0208 Rev. A

100 Calle Iglesia, San Clemente, CA 92672

Customer Service Email: [email protected] Phone: 1-844-YES-RESHAPE Fax: 949-276-6910

www.pro.ReShapeReady.com

reshape procedure reference guide · • no raw fruits and vegetables, coarse breads and cereals,...

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