Fw: Amelioration of systemic disease after removal of siliconegel-filled breast implants

[Guest guest]

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

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