Guest guest Posted March 1, 2001 Report Share Posted March 1, 2001 From: ilena rose <ilena@...> Sent: Wednesday, February 28, 2001 9:32 PM Subject: Amelioration of systemic disease after removal of siliconegel-filled breast implants > ~~~ thanks much to Kathy Nye (Kathynye@...) for this excellent study ~~~ > > > > (There are 3 charts I can send as .jpg if you want them.) Amelioration of > systemic disease after removal of silicone gel-filled breast implants > Journal of Nutritional & Environmental Medicine; Abingdon; Jun 2000; Arthur > E Brawer; Volume: 10 Start Page: 125-132 Abstract: > > One hundred and fifty-six patients who developed a systemic illness > following insertion of silicone gel-filled breast implants underwent > removal of these devices. The post explanation clinical course in > symptomatic recipients of silicone gel-filled breast implants was examined > in a study. Purpose: > > > > To examine the post explantation clinical course in symptomatic recipients > of silicone gel-filled breast implants. > > Design: Solo private practice-based evaluation. > > Materials and Methods: 156 patients who developed a systemic illness > following insertion of silicone gel-filled breast implants underwent > removal of these devices. Mean implantation time was 12 years, and > subsequent follow-up averaged 2.5 years. > > Results: 76/156 (49%) of patients noted amelioration of their disease > starting an average 9 months after gel device removal. Longer durations of > implantation were related to less clinical improvement, the latter > declining from 67% of those with final surgery after 7.5 years to 31% at > 14.5 years. Improvement was unaffected by prior rupture or multiple > surgeries, and could not be predicted by age, unilateral implant, or > subsets of clinical features. In 112/156 patients who opted for final gel > device removal without saline exchange, 10% of all improved patients > experienced paradoxical and simultaneous disease progression with the > appearance of new symptoms and signs. This phenomenon was unaffected by > prior rupture, multiple surgeries or prolonged implantation time, but had > a risk nearly five times as great in any of the 44/156 patients who > improved after gel for saline exchange. Transverse rectus abdominis > myocutaneous (TRAM) flap surgery performed after final gel device removal > was associated with a 50% incidence of panniculitis in the breast areas > and/or abdominal site. Self worth issues, usually via support groups, > often needed to be addressed simultaneously with ongoing medical > evaluation in order to effect explantation efforts in some seriously ill > patients. > > Conclusions: In this cohort of symptomatic breast implant recipients, > disease amelioration following explantation provides additional supportive > evidence for the existence of a novel illness triggered by silicone > gel-filled devices. The demonstrated improvement of systemic phenomena > following implant removal was more likely to occur if these devices were > in place for less than 12 years. Saline implants appeared capable of > perpetuating systemic disease progression following an initial gel-induced > disorder. INTRODUCTION > > The removal of silicone gel-filled breast implants in symptomatic > recipients exhibiting a variety of systemic phenomena has been followed by > clinical and laboratory improvement in some patients [1-11]. This is one > of many observations supporting the implication that these devices are > associated with the development of a novel illness. In general, post-- > explantation clinical data have lacked a comprehensive analysis of the > influence and effects of prior gel exposure time, disease severity, age, > multiple prior exchange surgeries, unilateral implant, subsets of clinical > features, saline implant replacement, transverse rectus abdominis > myocutaneous (TRAM) flap surgery or prior gel implant rupture. This report > attempts to address some of these issues. > > MATERIALS AND METHODS > > One hundred and fifty-six female patients who developed a systemic illness > beginning an average 2.5 years after insertion of silicone gel-filled > breast implants underwent removal of these devices. The women are part of > a larger cohort of 300 patients whose clinical features have previously > been described [12,13]. Systemic manifestations, disease severity, > chronological evolution, age, manufacturing diversity and ruptured devices > were comparable in the two groups as ascertained by a single > rheumatologist who interviewed and examined each patient directly. Mean > gel implantation time was 12 years. Subsequent follow-up after removal > averaged 2.5 years and was arranged by either re-examination or telephone > contact. > > The cohort was divided into five groups as noted in Table 1. Forty-four > patients opted for implant exchange whereby the removal of their gel > devices was followed immediately by saline implant replacement. > Improvement of the systemic illness was defined as a lessening of the > frequency and/or severity of at least 50% of the total number of symptoms > and signs manifested by a single patient. This did not require the > complete resolution of any one item, and could coexist with any of the > following scenarios (either singly or in combination): > > (1) no changes in the remaining symptoms and signs; (2) worsening of some > or all of the remaining symptoms and signs; (3) the appearance of new > symptoms or signs. Similar variabilities in the illness were recorded for > the unimproved patients, in whom observations may or may not have revealed > the simultaneous amelioration of a minority of their clinical features. > > RESULTS > > Group I > > Of the 27 patients who underwent removal of their original non-ruptured > implants, the final surgery was performed an average of 7.5 years after > implantation (span: 11 months to 18 years). Eighteen patients (67%) > improved over an average follow-up time of 34 months. The onset of > improvement began an average 9 months after explantation, with the > earliest amelioration noted at 2 months. Two of the improved patients > (11%) developed new systemic symptoms and signs despite their overall > improvement. The 9 unimproved patients were followed up an average 37 > months after explantation, with 1 (11%) manifesting new symptoms and > signs. > > Group 2 > > Ruptured original implants were removed in 48 patients. The average time to > rupture was 8.3 years (span: 2-21 years), and the average elapsed time from > implantation to final surgical removal was 12.83 years (span: 4-25 years). > The longest interval from rupture to final surgery was 13 years. > Improvement began an average 9 months following final surgery in 21 > patients (44%), with the earliest amelioration noted at 2 months. Two of > the 21 (10%) developed new symptoms and signs. Of the 27 unimproved > patients, 8 (30%) developed new systemic features. Follow-up time averaged > 26 months for each subdivision. The most striking finding in this category > was that rupture, by itself, did not determine whether or not improvement > occurred after explantation. A subgroup was analyzed where the total > implantation time for each patient was 10 years or less (average 7.5 > years; average time to rupture 6.25 years). Sixty-three percent of > patients in this subgroup improved, which is comparable to the improvement > rate of 67% in Group 1. Thus, the duration of gel device exposure (but not > rupture) appeared to determine whether or not improvement occurred > following explantation. Further analysis of this same subgroup revealed > that one-third of the unimproved patients developed new symptoms and > signs. Thus, rupture (but not gel device exposure time) appeared to > determine the threefold risk of disease progression in unimproved patients > following explantation. Surprisingly, neither rupture nor gel device > exposure time influenced the percentage of improved patients who developed > new symptoms and signs, which remained constant at 10%. > > The following case history is illustrative: > > A 33-year-old white female, previously in excellent health, underwent > bilateral cosmetic breast augmentation with the insertion of silicone > gel-filled breast implants. Postoperative breast numbness and capsular > contracture were followed 2 years later by the development of headaches, > neck pain, and depression. Within three additional years she complained of > abdominal cramps, loose stools, sinusitis, menstrual irregularities, > fatigue, pain and swelling in multiple small and large joints and two > hours of morning stiffness. Lateral implant displacement occurred in the > right breast accompanied by bilateral bogginess, heaviness, sagging, and > micronodularity. Over the next 9 years (up to the age of 47) she developed > skin dryness, forearm numbness, seizures, wheezing, palpitations, multiple > dental cavities, carpal tunnel syndrome, intermittent blurry vision, > tinnitus, dysphagia, dry eyes and dry mouth, diffuse myalgias, a > thirty-pound weight gain, oral ulcerations, intermittent periorbital > edema, fevers, eyelid twitching, chills, dizziness, cognitive dysfunction, > rib pains, nail cracking and splitting, skin rashes, itching, bilateral > greenish-black breast discharge and night sweats, none of which was > alleviated by the institution of estrogen replacement. Multiple laboratory > tests including chemistries, thyroid function, complete blood count (CBC) > sedimentation rate, anti-nuclear antibody, etc. were normal or negative, > and a computed tomography scan of the brain was normal. Bilateral ruptured > implants were removed, without replacement. Three months after > explantation, at the age of 48 (and extending over the next 24 months), > she began to notice gradual improvement (but by no means resolution) of > her polyarthritis, morning stiffness, palpitations, night sweats, chills, > dizziness, weight gain, depression, loose stools, abdominal cramps, > dysphagia, fevers, sinusitis, eyelid twitching, periorbital edema, rib > pains, tinnitus, forearm numbness, wheezing, headaches, mouth sores and > neck pain. Current physical examination at age 50 reveals anterior chest > wall telangiectasias, vitiligo and freckling; a positive Phalen's sign; a > Schirmer test exhibiting 0 mm of tear formation; parotid swelling; and > palmar erythema. > > Group 3 > > This category includes 8 patients who have undergone insertion and/or > exchange of multiple sets of silicone gel-filled breast implants, with no > documented ruptures, followed by final gel device removal. Total > implantation time averaged 8.75 years (span: 3-17 years; longest single > set = 9 years). The entire group had an average 28-month follow-up, but > the number of patients was too small for comparable analysis. > > Group 4 > > Twenty-nine patients had multiple sets of silicone gel-filled breast > implants inserted and/or exchanged, with at least one documented rapture. > The time from initial implantation to final surgery averaged 14.5 years > (span: 3-22 years), and the average time to rupture was 6.67 years (span: > 2 months to 16 years). Nine patients (31%) experienced improvement > beginning an average 10 months after final explantation, with the earliest > improvement noted at 4 months. One of these patients (11%) developed new > symptoms and signs. Of the 20 unimproved patients, 5 (25%) developed new > phenomena. Follow-up averaged 28 months for both subdivisions. > > Within this explantation category a subgroup was analyzed, where the total > implantation time for each patient was 16 years or less (average 13 years). > Forty percent of this subgroup experienced improvement, which is comparable > to 44% in Group 2. This reinforces the observation (in this series of > patients) that the length of time of gel device exposure (but not rupture) > determined whether or not improvement occurred following explantation. The > following case history is illustrative: > > A 27-year-old white female with postpartum breast atrophy underwent > bilateral insertion of silicone gel-filled implants. Postoperative breast > itching and capsular contracture were followed one year later by recurrent > urinary tract infections, leg edema and a skin rash on the trunk, at which > time implant exchange was performed using another set of silicone > gel-filled devices. Recurrent capsular contracture was accompanied at age > 32 by hair loss, fatigue, nausea, weight loss, anterior chest pain and > myalgias. At age 35 an excised breast nodule revealed silicone granuloma, > and mammography was positive for bilateral rupture. At age 43, having > developed livedo reticularis, polyarthritis, dry eyes and dry mouth, one > hour of morning stiffness, periorbital edema, headaches and leg > varicosities, she underwent bilateral implant exchange for a third set of > silicone gel-filled breast implants. At the time of surgery it was noted > that there was " gel all over the place. " Capsular contracture recurred, > and one year later diffuse skin freckling developed along with cognitive > dysfunction and extremity dysesthesias. Bilateral implant exchange for a > fourth set of silicone gel-filled breast implants revealed that the third > set had already ruptured. Two years later, at age 46, she was noted to > have diffuse telangiectasias on the anterior chest wall, splotchy > hyperpigment > > > > > > Quote Link to comment Share on other sites More sharing options...
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