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Device Problem Migration (4003)
Patient Problems Abdominal Pain (1685); Arthritis (1723); Fatigue (1849); Foreign Body Reaction (1868); Inflammation (1932); Pain (1994); Pleural Effusion (2010); Scar Tissue (2060); Ambulation Difficulties (2544); Pericarditis (4448)
Event Date 01/17/2021
Event Type  Injury  
Manufacturer Narrative
Product complaint #(b)(4). Attempts are being made to obtain the following information. To date no response has been provided. If further details are received at a later date a supplemental medwatch will be sent. Does ethicon have your permission to contact your surgeon, in the event ethicon would like to contact your surgeon for more clinical information to be used for a product quality complaint investigation? if so, please provide your surgeon¿s name, contact information and sign release of medical information form attached. Additional information was requested and the following was obtained: please provide procedure name and date: (b)(6) 2022. Please provide product code: n/a ultra pro mesh. Please provide lot number: n/a. Was any quality deficiency/non-conformance noted with the mesh before use, during use, during post-op examination or during re-operation if performed? mesh was found folded during removal with adhesions all over body cavity including intestines and abdominal wall on (b)(6) 2022. See timeline below. Please clarify what are the alleged patient adverse event(s) associated to the use of the mesh? symptoms of mesh rejection including pain, fatigue, joint pain and then hospitalized in (b)(6) 2021 for pericarditis and plural effusions due to difficulty breathing. No virus or autoimmune disease was found with blood tests after hospitalization. Was there any medical or surgical intervention performed to treat the alleged adverse event(s)(re-operation; re-suturing; prescription steroids; antibiotics prescribed)? antibiotics and long term steroids prescribed. What is the most current patient health status and condition? health issues have improved but still have pain with deep breathing and scarring in lungs, and seeing the pulmonologist in june. Timeline from 2015 to present: on (b)(6) 2015, after pain increased after sitting all day in a desk job in pain, i discussed symptoms of a possible hernia with dr (b)(6). , with the surgical associates of mid-cities. Dr (b)(6). Ordered an mri to view the pelvis. On (b)(6) 2015, mri completed, no findings except osteoarthritis and bursitis in hips. However, pain was consistent after sitting all day and sought out alternative therapies. The best explanation i could give to my health practitioners was that it felt like a mass. Started visits to a chiropractor for hip and back adjustments with therapeutic massage of legs, hip, and pelvic area. Pain relieved some after stretching and massage, noted as intermittent and moderate. An x-ray was taken with no findings. In (b)(6) 2019, due to long term chronic pain, an exploratory laparoscopy was performed by ob/gyn, dr robert wai, and stated no endometriosis, adhesions, scar tissue or hernias present. On (b)(6) 2019, an endoscopy of the colon was performed, no significant findings. During the month of (b)(6) 2019, pelvic x-rays completed and ruled out any orthopedic issues with no significant findings. On (b)(6) 2019, returned to dr (b)(6) to discuss options of another exploratory surgery, he stated mesh was more advanced and was less of a risk now then back in 2015. He stated he personally had mesh inserted for his own hernia and downplayed the issues of mesh. On (b)(6) 2019, dr (b)(6) performed laparoscopic surgery. An indirect and direct inguinal hernia was found and 3 by 6 inches of ultrapro mesh was applied to the area. A fatty lipoma around the round ligament was discovered and reduced. Another lipoma was removed from inner thigh on the skin surface. On (b)(6) 2019, at the first post-operative visit, i experienced consistent abdominal pain since surgery. Dr (b)(6) sent me for a hida scan and possibly related to gall bladder issues but discovered no findings. Returned to work with severe abdominal pain that only resolved after fasting and drinking fluids for several days. In early to mid 2020, started to experienced shortness of breath and noticed my allergies worsened. Visited dr (b)(6) , completed allergy testing and started immunology shots for newly discovered mold allergies. Went on short term disability due to severe mold allergies and difficulty breathing. Urgent care visit on (b)(6) 2020 for covid pcr test, negative after known exposure. Prescribed zithromax for difficulty breathing. No coughing present, tests for covid and flu a and b, all negative. Urgent care visit on (b)(6) 2020 for difficult breathing and prescribed inhalation medications for mild asthma. Tests for covid and flu a and b, negative. On (b)(6) 2020, shortness of breath and pain upon inspiration worsened, however, no respiratory symptoms or cough present. Dr. (b)(6) ordered an x-ray with no findings. On (b)(6) 2020, after suffering with excruciating lower back pain near kidneys, i urgently went to the baylor grapevine urgent care / er. The er doctor started iv fluids with toradol and ordered a cat (ct) scan due to a possible kidney stone because of severe pain. However, a stone was not found, but discovered a pleural effusion that was possibly caused pain with breathing. On monday, my primary care office called me and placed me on antibiotics for the pleural effusion and pneumonia which he thought was viral. No coughing was present. I had trouble breathing from severe pain related to the pleural effusions. Referred to pulmonologist, dr (b)(6) in (b)(6). Short term disability was recommended and approved from (b)(6) 2021 until (b)(6) 2021. On (b)(6) 2021, returned to baylor urgent care in keller for severe chest pain, another ct scan of heart and lungs completed, pericarditis, pleural effusion and elevated d-dimer were noted and placed on observation overnight and hospitalized due to the possibility of blood clots. Discharged the next night. On (b)(6) 2021, appointment with pulmonologist, dr. David (b)(6), with the lung and sleep clinic. Performed lung function test, results of 39%. Diagnosis was probable viral pneumonia and pleural effusion. On (b)(6) 2021, severe chest pain returned, went to baylor emergency in grapevine. Ekg, ct scan were performed, and er doctor stated he believed the heart and lung issues were autoimmune associated and not from a virus. Heart rate was consistently elevated. Referred to rheumatologist for further testing. D-dimer still elevated. On (b)(6) 2021, had covid antibody test at labcorp to rule out any possible past infections of covid. Test was negative. This was the 2nd negative antibody test performed during the pandemic to rule out past infections. On (b)(6) 2021, dr. (b)(6), from rheumatology associates, ran several blood tests, ordered x-rays of knees, and found no autoimmune diseases in blood work. Diagnosis: polyarthritis, chronic idiopathic pericarditis, pleural effusion. ¿ on (b)(6) 2021, appointment with (b)(6), pa-c at direct orthopedic care due to difficulty walking and bending legs, x-rays of knees completed. Inflammation in both knees present, 20-30 milliliters of fluids withdrawn from both knees, and steroids injected. Prescribed etodolac for pain and inflammation. ¿ on (b)(6) 2021, since my surgeon relocated to california, i returned to surgical associates of mid-cities and spoke to his colleague, dr robert pollard. He stated he never removed a mesh in his 30 years of practice, thought it was not a foreign body reaction or mesh rejection and that removing the mesh would be a significant undertaking and he would not be involved. He stated, i did not have clear evidence even though i had blood work showing inflammation with the c-reactive protein and d-dimer blood tests along with infection markers and inflammation in my heart and lungs. On (b)(6) 2021, a 4th ct was completed at envision imagining ordered from pulmonologist, dr david ostransky. Results stated a small left pleural effusion of unknown etiology with lower lungs demonstrating linear platelike atelectasis and scarring bilaterally. ¿ on (b)(6) 2021, at (b)(6) and white cardiovascular consultants, a transthoracic echocardiogram was completed, and results showed a resolution of pericarditis. On (b)(6), was pressured to leave my position due to errors, poor performance, and continuous health issues that made it difficult to keep up in a fast-paced environment. I was losing massive amounts of hair and suffered brain fog without any explanation. I was put on a performance improvement plan and was continuously micromanaged. Due to poor health, i left the job and filed for unemployment due to the stressful work conditions, and health issues. I was approved by the state of texas unemployment office for unemployment benefits. On (b)(6) 2021, infectious disease physician, dr (b)(6), tested for several infectious diseases and recent viral antibodies with no findings. During the next few months, my condition did not improve until i started a long term, low dose steroid regimen. After finding no autoimmune, infectious diseases or recent viral infections, i joined several mesh support-groups online to research a possible connection of a foreign body reaction to the mesh. Talked to several members of the group with similar experiences and researched removal options from the physicians recommended. In (b)(6) 2021, i flew to the cleveland clinic for an appointment with dr. (b)(6) to discuss removal of the mesh due to autoimmune issues, chronic groin pain with abdomen tenderness and past issues with severe inflammation of joints, lungs, and heart. He agreed to remove the mesh and scheduled surgery in january of 2022. On (b)(6) 2022, laparoscopic surgery was performed by dr k(b)(6), findings included significant intrabdominal adhesions with excision of 100 percent of the right inguinal mesh which had folded at the inferior portion as well as the tendon flexion of the epigastric vessels. Adhesiolysis was performed due to the significant interloop adhesions of the entire abdominal wall, small bowel, omentum, and colon. The surgery was approximately 3. 5 hours long. Due to the amount of significant intrabdominal adhesions around the colon and small bowel, dr (b)(6) recommended two nights in the hospital for observation due to the possibility of organ perforation during surgery. ¿ on (b)(6) 2022, after two nights in the hospital, i was discharged and stayed locally to recover from surgery. I immediately felt an improvement in my well-being after the mesh removal and was able to walk and breathe without pain. On (b)(6) 2022, post-surgery appointment with dr. Sivaraman from rheumatology associates, confirmed the foreign body reaction with autoimmune issues and adhesions directly related to the mesh implant due to all blood tests for autoimmune diseases were negative. These findings conclude a reaction was directly related to the mesh implant. Present day, (b)(6) 2022, healed from surgery without any issues, feel energetic, no more joint issues, deep breathing is painful due to scarring in lungs. Event related to patient's mesh removal surgery on (b)(6) 2022 submitted via mw # 2210968-2022-04371.
Event Description
It was reported that a patient underwent a laparoscopic inguinal hernia repair on (b)(6) 2019 and the mesh was implanted. It was reported that the patient experienced symptoms of mesh rejection including pain, fatigue, joint pain and then hospitalized in (b)(6) 2021 for pericarditis and plural effusions due to difficulty breathing. No virus or autoimmune disease was found with blood tests after hospitalization. It was also reported that the patient had antibiotics and long-term steroids prescribed. It was reported that the mesh was found folded during removal with adhesions all over body cavity including intestines and abdominal wall on (b)(6) 2022. Additional information was requested.
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Manufacturer (Section D)
1000 route 202
raritan NJ 08869
Manufacturer (Section G)
robert-koch strasse 1
p.o. box 1409
norderstedt 22841
GM 22841
Manufacturer Contact
elba bello
1000 route 202
raritan, NJ 08869
MDR Report Key14638942
MDR Text Key293634597
Report Number2210968-2022-04408
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation
Type of Report Initial
Report Date 06/08/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/08/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Date Manufacturer Received05/09/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Initial

Patient Treatment Data
Date Received: 06/08/2022 Patient Sequence Number: 1