Patient information on the MiniMIZER RING gastric ring implant

(according to MDR Article 18)

Dear Patient, 
We, Bariatric Solutions International GmbH based in Switzerland, have been known in the field of bariatric surgery around the globe for more than a decade. We have developed a portfolio of alternative, innovative products and would like to continue to do so. We focus all our efforts on helping patients achieve a new quality of life. One of the ways we achieve this is by providing surgeons with new options and improved materials to make their work safer, faster and better. By deciding to have a MiniMIZER gastric ring implanted by Bariatric Solutions International GmbH, you have made an excellent choice. We wish you every success in this new phase of your life.

The MiniMIZER RING is indicated for patients with a Body Mass Index (BMI) greater than 35 (if they have two comorbidities), or with a BMI greater than 40. The MiniMIZER RING is implanted in patients who, due to their morbid obesity, require a gastric bypass, mini gastric bypass, sleeve gastrectomy or revisions of these previous procedures in order to achieve weight loss.

The MiniMIZER RING forms a passive restriction around the newly formed stomach. The implantation is intended to prevent enlargement of the residual stomach or enlargement of the gastrointestinal connection. This results in long-term and sustainable weight loss. 
We want you to lose weight successfully and would therefore like to provide you with some important information. Please read the following information carefully and contact your doctor if you have any questions.

International Implant Card 
After your surgery, you will have received an implant ID card. On this card you will find all the information you need to identify the product, including the product name, the lot number, the unique device identifier (UDI), the reference number and our address.

Explanation of the symbols on the implant card

Instructions for the patient on what to do after using a MiniMIZER gastric ring

After implantation of the MiniMIZER RING, it is important that you adhere to the eating, drinking and behavioural recommendations of your bariatric surgeon.

Possible side effects and complications

Undesirable side effects that could be caused by the insertion of a MiniMIZER gastric ring are: 
• Vomiting and nausea
• Foreign body sensation
• Acid reflux

If you suffer from any of these side effects, diarrhea or abdominal pain, please contact your doctor immediately.

Possible extremely rare complications/risks that could occur are:
• Blockage of the esophageal-gastric passage
• Erosion (abrasion of the stomach wall by the gastric ring)
• Migration (ingrowth of the gastric ring through the stomach wall)
• Slipping
• Silicone allergy

Precautionary measures
Eating too quickly, without adequate intervals and/or without adequate chewing can cause food to get stuck in the stomach, which in turn can trigger vomiting.

If the stuck food does not dislodge promptly, it may need to be removed gastroscopically (through the mouth/esophagus).

During weight loss, patients must be regularly examined by a doctor for signs of deficiency, anemia or other related complications.

Anti-inflammatory medicine that can irritate the stomach, such as aspirin and steroid-free anti-inflammatory medicine, should only be taken with precautions and after consulting your doctor.

Interaction with other medical devices used
There are no known risks that could arise from interaction with other medical devices in use. Therefore, there are no known precautions or other measures that should be taken by the patient or a healthcare professional.

Interactions with medical imaging procedures
The MiniMIZER RING is compatible with common medical imaging techniques such as X-ray and magnetic resonance imaging (MRI). However, always inform the doctor or healthcare professional of the presence of the implant.

The MiniMIZER RING does not show up in screening procedures of Terraherz scanners at airports or stores. If you are unsure, point out the implant to the staff.

Regular checks and monitoring by a doctor
a) Patients who have undergone bariatric surgery must be examined regularly by their doctor. This also applies to cases in which the MiniMIZER RING has been used.
b) If the MiniMIZER RING malfunctions, food intake can be painful, difficult or even impossible.
c) If the patient notices any of the above symptoms, they should immediately consult the doctor who implanted the MiniMIZER RING.
d)  It should not be assumed that the implant will last indefinitely, although there is no evidence to date that the product properties of the MiniMIZER RING have deteriorated. Bariatric Solutions International GmbH relies on your surgeon to responsibly explain all potential risks of the surgery to you.
e) There are currently no known factors that could shorten or extend the life of the gastric ring.
f) There are currently no known precautions or other measures that should be taken at or near the end of the expected life of the gastric ring.
g) If weight regain occurs, the patient should consult the implanting doctor immediately.

Materials and components
The implant consists of silicone with 7% barium sulphate and 0.25% color masterbatch. There are no manufacturing residues that could pose a risk to the patient.

Reporting
Any serious incident that occurs in connection with the medical device should be reported immediately to the manufacturer and the responsible authority.

Further information for attending doctors
Further information for attending doctors can be found on our website https://bariatric-solutions.com/minimizer-gastric-ring/ or by contacting us directly: info@bariatricsolutionsinternational.com.

Your Bariatric Solutions International Team