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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC OBTRYX TRANSOBTURATOR MID-URETHRAL SLING

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BOSTON SCIENTIFIC OBTRYX TRANSOBTURATOR MID-URETHRAL SLING Back to Search Results
Device Problems Degraded (1153); Patient-Device Incompatibility (2682); Extrusion (2934); Material Deformation (2976)
Patient Problems Syncope (1610); Abdominal Pain (1685); Rheumatoid Arthritis (1724); Autoimmune Disorder (1732); Autoimmune Reaction (1733); Eye Injury (1845); Fatigue (1849); Fever (1858); Foreign Body Reaction (1868); Incontinence (1928); Inflammation (1932); Neurological Deficit/Dysfunction (1982); Neuropathy (1983); Occlusion (1984); Pain (1994); Positive antinuclear antibodies (ANA) (2015); Raynauds Phenomenon (2034); Scar Tissue (2060); Seroma (2069); Sjogren's Syndrome (2073); Thyroid Problems (2102); Transient Ischemic Attack (2109); Brain Injury (2219); Therapeutic Response, Decreased (2271); Disability (2371); Prolapse (2475); Vascular System (Circulation), Impaired (2572); Test Result (2695)
Event Date 12/07/1999
Event Type  Injury  
Event Description
My name is (b)(6).Once upon a time, i was a healthy, active person, happily married to my high school sweetheart, raising a wonderful son, and working as an admin for a cancer treatment facility.All that completely changed on (b)(6) 1999, when mesh material was first implanted to repair an abdominal hernia.In order to present the entire complexity of my unique mesh-related experience, i have chosen a chronological format: the pain, exhaustion, low-grade fever, overall achiness and seroma development started almost immediately.Ethicon prolene mesh by johnson & johnson, caused an autoimmune reaction in my body.I never recovered from the surgery, and i lost my job due to the fact that i was unable to return to work.It was truly devastating.I kept returning to the doctors, begging for them to help me.I wanted the mesh removed, but was told to "wait and see".I was sent to specialists, had many tests, and was told several times, "off the record, " that my body was reacting to the mesh.Since the implantation of mesh, i was diagnosed with one autoimmune disease after another.At that time, i was (b)(6) and my world was falling apart.What happened to that healthy, happy woman, the wife and mother? i was medically disabled and unable to work outside the home.I needed assistance with everything.It took nearly 4 years for me to get (b)(6), so we suffered financially as well.There was no "recovery" or "getting better".I was now permanently disabled and chronically ill.In (b)(6) 2009, bloodwork revealed a positive ana as my body continued to react to the mesh material.This complex autoimmune process continued to worsen and in (b)(6) 2009, i had to stop receiving biologic.By (b)(6) 2009, the mesh had degraded to such a point and the foreign body reaction became life-threatening, so a second surgery was required.On (b)(6) 2010, the hardened, shriveled mass of mesh and tissue was removed and replaced with alloderm biologic mesh and some other prolene mesh by bard.The surgeon would not use ethicon mesh again, and hoped that these other products would be better tolerated by my body, but that was not the case.I continued to have abdominal pain, seromas, low grade fevers, along with all the autoimmune diseases that came with the use of mesh.Now, we get to the prolapsed bladder.In 2011, i began having a new pain my lower abdomen and urinary incontinence.It also felt like something was hanging out of my vagina.On (b)(6) 2011, i had tot surgery and the beryx transobturator mid-urethral sling by boston scientific was implanted.From the urologist's perspective, the device is "still where he left it".From my perspective, i continue to leak urine, and i feel a constant poking, stabbing pain in my vagina.It hurts more than usual to sit, stand up, bend down, squat and walk.Sexual relations are impossible without unbearable pain.Lastly, on (b)(6) 2012, i had an abdominal reconstructive surgery with removal of scar tissue.Part of that removal included a "lemon-sized, strange looking mass," as the surgeon called it.Yes, it was more degraded, shrunken mesh.I am now (b)(6).I have had a total of 5 tias (mini-strokes) due to small vessel disease, which is also related to the autoimmune response.I currently take 16 prescribed medications daily.Being disabled for 15 years, you learn to accept and adjust.You try your best to stay positive and thank god for a loving support system.You put the past behind you and try to focus on the things you are still able to do.Because of this bladder sling, i have even more pain, leak urine and now am unable to have sexual relations with my husband.It's bad enough to have been healthy and then become disabled, but to already be disabled and then be further impaired is worse! be it ethicon, alloderm, bard, or obtryx, these mesh materials have made me ill and have caused irreparable damage to my body.I have lost wages and potential income, shattered hopes, dreams and pains, and placed an enormous amount of stress on my relationships.I find it unconscionable that the companies that manufacture these products continue to deny any responsibility for the bodily injuries and impact on the quality of life suffered by people like me.List of diagnoses received after mesh implantation: abdominal pain, branch retinal vein occlusion, cerebral hypoperfusion, diabetes, fibromyalgia, gerd, hashimoto's disease, hyperactive bladder, irritable bowel, lumbosacral neuritis, myofascial pain, neurocardio syncope, optic neuritis, peripheral neuropathy, rheumatoid arthritis, raynaud's disease, sjorgen's syndrome, small vessel disease, tia.
 
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Brand Name
OBTRYX TRANSOBTURATOR MID-URETHRAL SLING
Type of Device
SLING
Manufacturer (Section D)
BOSTON SCIENTIFIC
MDR Report Key3977560
MDR Text Key4631999
Report NumberMW5037576
Device Sequence Number3
Product Code OTP
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 07/08/2014
3 Devices were Involved in the Event: 1   2   3  
1 Patient was Involved in the Event
Date FDA Received07/30/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Patient Sequence Number1
Treatment
L-THYROXINE 1 50MCG; QVAR INHALER 1 80MCG; RESTASIS 2 0.05%; PROVIGIL 1-2 200MG; ASPIRIN 1 324MG; RHINOCORT 2 SPRAY; METFORMIN ER 3 500MG; LIXINOPRIL 1 40MG; LIPITOR 1 80MG; LIDODERM PATCH 2; PLAVIX 1 75MG; SINGULAR 1 10MG; VESICARE 1 5MG; ALLODERM BIOLOGIC MESH; CYMBALTA 1 60MG; LOTEMAX 3 0.5%; SKELAXIN 3 800MG
Patient Outcome(s) Hospitalization; Other; Disability;
Patient Age38 YR
Patient Weight98
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