MAUDE Adverse Event Report: MCGHAN SILICONE TISSUE EXPANDERS; BREAST IMPLANT

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Rheumatoid Arthritis (1724); Autoimmune Disorder (1732); Fatigue (1849); Fever (1858); Gastritis (1874); Hair Loss (1877); Headache (1880); Unspecified Infection (1930); Inflammation (1932); Memory Loss/Impairment (1958); Muscle Weakness (1967); Nausea (1970); Pain (1994); Rash (2033); Swollen Lymph Nodes (2093); Vomiting (2144); Burning Sensation (2146); Arthralgia (2355); Joint Swelling (2356); Post Operative Wound Infection (2446); Weight Changes (2607); No Code Available (3191); Constipation (3274)

Event Date 10/31/2014

Event Type  Injury  

Event Description

I had a prophylactic bilateral mastectomy with reconstruction using inamed aesthetics mcghan silicone tissue expanders on (b)(6) 2009.I experienced problems with the tissue expander in the right breast as it shifted position frequently and caused infection twice and was treated with minocycline (which i eventually developed an allergic reaction to that particular antibiotic).The infection would not clear up and that resulted in having to undergo surgery to remove expanders and place implants earlier than anticipated.The expanders were removed and natrelle silicone-filled breast implants (style 20) were placed on (b)(6) 2009.The left breast is 500cc ref 20-500 sn (b)(4) and the right breast is 500cc ref 20-500 sn (b)(4).In (b)(6) 2012, i began experiencing severe nausea, vomiting, constipation, and weight loss (dropped nearly 40 pounds in two months).I saw my pcp and they did extensive testing and diagnostic imaging.A tumor was found in the hysterectomy bed (history of cancer and complete hysterectomy and left salpingo oophorectomy in (b)(6) 2005 and subsequent right salpingo oophorectomy in (b)(6) 2010).Surgery revealed large benign tumor.The gi problems were removed and i was diagnosed with esophagitis and gastritis.A year later, (b)(6) 2014, i began having joint pain that would not go away despite otc nsaids.In (b)(6), i saw my pcp who referred me to a rheumatologist.I saw the rheumatologist and was diagnosed on (b)(6) 2014, with rheumatoid arthritis.Since then, i have taken imuran, enbrel, prednisone, lyrica, and vimovo.None of the medications have provided reprieve from my symptoms.I began to become skeptical of the ra diagnosis, so i began researching my medical records and found a disclaimer in the surgical consent forms for the silicone implants that there may be a link between silicone implants and autoimmune diseases such as sle, ra, scleroderma, and other arthritis-like conditions.Since 2012, i have experienced and continue to experience to a greater degree all the symptoms noted: swelling and/or joint pain or arthritis-like pain, general aching, unusual hair loss, unexplained or unusual loss of energy, more susceptible to colds, flu, etc., swollen glands and lymph nodes, rash (on face that has been diagnosed as seborrheic dermatitis suggestive of autoimmune disease), severe memory problems, headaches, muscle weakness or burning, nausea, vomiting, ibs, and fever.I do not believe that is merely coincidental as i never had problems like this prior to the mastectomy and reconstruction.Therefore, i conclude that the silicone expanders and implants are directly related to my symptoms and condition.Possibly, other variables could contribute such as genetic predisposition and environmental factors.However, in my case there is enough medical data to indicate a causal relationship between the silicone expanders and implants to my autoimmune disease and symptoms.I hypothesize that the reason i have not responded to nsaids (otc and rx), dmards, and biologics is because the root of the problem is the silicone implants.I have an appointment with my rheumatologist on (b)(6) and will report my findings to him.May i request that a representative of the fda follow-up with me regarding my report? (b)(6).

• Brand Name: SILICONE TISSUE EXPANDERS
• Type of Device: BREAST IMPLANT
• Manufacturer (Section D): MCGHAN
• MDR Report Key: 4231760
• MDR Text Key: 4971239
• Report Number: MW5038964
• Device Sequence Number: 1
• Product Code: LCJ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 10/31/2014
• 4 Devices were Involved in the Event: 1 2 3 4

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 35 YR
• Patient Weight: 52