This page contains information that may be useful in filing a breast implant claim under the current MDL926 Revised Settlement (Manufacturers: Bristol, Baxter, 3M and McGhan).  As you may know, women submitting a claim for benefits under this settlement will need to meet the necessary medical criteria in at least one of the criteria types listed below to receive disease benefits. (you must meet either ARS, GCTS, Lupus, etc.)  This is assuming that you have Acceptable Proof of one or more breast implants inserted before June 1st of  1993 that is covered under this settlement.
 

             ARS Criteria            
Atypical Rheumatic Syndrome / Atypical Connective Disease / Nonspecific Autoimmune Condition

In order to qualify for a Diagnosis for Atypical Connective Disease/Atypical Rheumatic Syndrome/Nonspecific Autoimmune Conditions would require:

___   One or more signs or symptoms listed in Category I and one from Category II.

___   Three signs or symptoms from Category II.

___   Two signs or symptoms from Category I.

___   Two signs or symptoms from Category II plus one non-duplicative sign or symptoms from  Category III.

___   A total of Five non-duplicative signs or symptoms from any of the Categories I through  III.

Category I

A. Raynaud's phenomenon                                        
B. Polyarthritis

       
C. Keratocunjunctivitis Sicca:  subjective complaints of dry eyes and/or dry mouth accompanied by one of the
     following:

      1.  Lacrimal or salivary enlargement

      2.  Parotid enlargement

      3.  Abnormal Schirmer's testing

      4.  Abnormal Rose-Bengal staining

      5.  Filamentous keratitis

      6.  Abnormal parotid scan or ultrasound

      7.  Abnormal CT or MRI or parotid or

      8.  Abnormal labial salivary biopsy
 

Category II

A. Myalgias

B. Immune mediated skin changes or rash as follows:

     1. Changes in texture or rashes that may or may not be characteristic of SLE, Systemic Sclerosis             
     2. (Scleroderma) or Dermatomyositis diffuse petechiae, telangiectasias or levido reticularis

C. Pulmonary symptoms or abnormalities, which may or may not be characteristic of SLE,
     Systemic Sclerosis (scleroderma) or Sjorgren's Syndrome as follows:

     1.  Pleural and/or interstitial lung disease
     2.  Restrictive lung disease
     3.  Obstructive lung disease as evidenced by characteristic clinical findings and  either:

          a.  Characteristic chest x-ray changes or
          b.  Characteristic pulmonary function test abnormalities in a non-smoker (e.g. decrease DLCO or
               abnormal arterial blood gases).

D. Pericarditits

E. Neuropsychiatric Symptoms
F. Peripheral neuropathy diagnosed by physical examination showing one or more of the following:

       1.  Loss of sensation to pinprick or vibration or touch or position tingling,   
       2.  Paresthesias or burning pain in the extremities
       3.  Loss of tendon reflex
       4.  Proximal or distal muscle weakness (loss of muscle strength in extremities or weakness of ankles, hands
            or foot drop)
       5.  Signs of dysesthesia or
       6.  Entrapment neuropathies

G. Myositis or myopathy:

     1.  Diagnosed by weakness or physical examination or by muscle strength testing abnormal
          CPK or aldolase.

     2.  Abnormal cybex testing
          Abnormal EMG
          Abnormal muscle biopsy

H. Serologic abnormalities:

     1.  ANA> or equal to 1:40 (using Hep2)
     2.  Positive ANA profile such as Anti-DNA, SSA, SSB, RNP, SM.  Sci-70,  centromere, Jo-1, PM-Sci or
          dsDCA  (preferable to use ELISA with standard cutoff)                      

     3.  Other autoantibodies, including thryroid antibodies, anti-microsomal, anti-cardiolipin, or RF 
          (by nephelometry with 40IU cutoff)
     4.  Elevation of immunoglobulin (IgG, IgA, IgM)
     5.  Serologic evidence of inflammation such as elevated ESR, CRP.

I.  Lymphadenopathy (as defined by at least 1 lymph node greater than or equal to 1x1 cm).

J.  Dysphagia with positive cine-ecophagram, manometry or equivelent imaging.

Category III

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GCTS  Criteria
General Connective Tissue Syndrome 

The following information is reprinted from the MDL-926 Settlement booklet. 

 V. General Connective Tissue Symptoms (GCTS):

A claim for GCTS does not have to include a diagnosis for “General Connective Tissue Symptoms,”  but the medical documentation must establish that the combination of findings listed below are present. [Exclusion:  classical rheumatoid arthritis diagnosed in accordance with the revised 1982 ACR classification criteria.]

For compensation at Level A:

(1)    any two findings from Group I; or
(2)    any three non-duplicative findings from Group I or Group II.

For compensation at Level B:

(1)    one finding from Group I plus any four non-duplicative findings from Group II or Group III; or
(2)    two findings from Group II plus one non-duplicative finding from Group III.

The following duplications exist on the list of findings:

* Rashes (#3 and #8)
* Sicca ($2 and #12)
* Serological abnormalities (#4 and #9)

In addition to the medical verification of the required findings, a claim for GCTS must include the affirmative physician statements outlined in General Guidelines above.

GROUP I FINDINGS

1.  Polyarthritis, defined as synovial swelling and tenderness in three or more joints in at least two different joint
     groups observed on more than one physical examination by a board-certified physician and persisting for
     more than six weeks.  

     [Exclusion: osteoarthritis.]

2.  Keratoconjunctivisits Sicca, defined as subjective complaints of dry eyes and/or dry mouth,
     accompanied (a) in the case of dry eyes, by either (i) a Schirmer’s test less than 8 mm wetting per 5
     minutes or (ii) a positive Rose-Bengal or fluorescein staining of cornea and conjuctiva;  or (b) in the
     case of dry mouth, by an abnormal biopsy of the minor salivary gland (focus score of greater than or
     equal to two based upon average of four evaluable lobules).  
    
     [Exclusions:  Drugs known to cause dry eyes and/or dry mouth, and dry eyes caused by contact
       lenses.]

3.  Any of the following immune-mediated skin changes or rashes, observed by a board-certified
     rheumatologist or board-certified dermatologist;
    
     (a) biopsy-proven discoid lupus;
     (b) biopsy-proven subacute cutaneous lupus;
     (c) malar rash-fixed erythema, flat or raised, over the malar eminences, tending to spare the nasolabial folds 
          [exlusion:  rosacea or redness caused by sunburn]; or
     (d) biopsy-proven vasculitic skin rash.

GROUP II FINDINGS

4.  Positive ANA greater than or equal to 1:40 (using Hep2), on two separate occasions separated by at
     least two months and accompanied by at least one test showing decreased complement levels of C3
     and C4; or a positive ANA greater than or equal to 1:80 (using Hep2) on two separate occasions
     separated by at least two months. All such findings must be outside of the performing laboratory’s
     reference ranges.

5.  Abnormal cardiopulmonary symptoms, defined as
    
     (a) pericarditis documented by pericardial friction rub and characteristic echocardiogram findings (as reported
          by a board-certified radiologist or cardiologist);
    
     (b) pleuritic chest pain documented by pleural friction rub on exam and chest x-ray diagnostic by a board-
          certified radiologist); or
    
     (c) interstitial lung disease in a non-smoker diagnosed by a board-certified internist or pulmonologist,
          confirmed by (i) chest x-ray or CT evidence (as reported by a board-certified radiologist) and (ii)  
          pulmonary function testing abnormalities defined as decreased DLCO less than 80% of predicted.

6.  Myositis or myopathy, defined as any two of the following:

     (a) EMG changes characteristic of myositis; short duration, small, low amplitude polyphasic potential;
           fibrillation potentials; and bizarre high-frequency repetitive discharges;
    
     (b) abnormally elevated CPK or adolase from the muscle (outside of the performing laboratory’s reference
           ranges) on two separate occasions at least six weeks apart. (If the level of the initial test is three times
           normal or greater, one test would be sufficient.) 

           [Exclusions: injections, trauma, hypothyroidism, prolonged exercise, or drugs known to cause
            abnormal CPK or aldolase]; or
    
     (c)  muscle biopsy (at a site that has not undergone EMG testing) showing evidence of necrosis of type 1 and
           2 muscle fibers, phagocytosis, and an interstitial or perivascular inflammatory response interpreted as
           characteristic of myositis or myopathy by a pathologist.

7     Peripheral neuropathy or polyneuropathy, diagnosed by a board-certified neurologist, confirmed by
    
     (a) objective loss of sensation to pinprick, vibration, touch, or position,;
     (b) symmetrical distal muscle weakness;
     (c) tingling and/or burning pain in the extremities; or
     (d) loss of tendon reflex, plus nerve conduction testing abnormality diagnostic of peripheral neuropathy or
          polyneuropathy recorded from a site that has not undergone neural or muscular biopsy. 
         
          [Exclusions:  thyroid disease, antineoplastic treatment, alcoholism or other drug dependencies,
           diabetes, or infectious disease within the last three months preceding the diagnosis.]

GROUP III FINDINGS

8.  Other immune-mediated skin changes or rashes, observed by a board-certified rheumatologist; or
     board-certified dermatologist;

     (a) livedo reticullaris;
     (b) lilac (heliotrope),  erthematous scaly involvement of the face, neck, shawl; area and extensor surfaces of
          the knees, elbows and; medial malleoli;
     (c) Gotton’s sign, pink to violaceous scaling areas typically found over the knuckles, elbows, and knees; or
     (d) diffuse petechiae.

9.  Any of the following serologic abnormalities;

     (a) ANA greater than or equal to 1:40 (Using Hep2) on two separate occasions separated by at least two
          months;
     (b) one or more positive ANA profile; Anti-DNA, SSA SSB, RNP,SM,  Scl-70, centromere, Jo-1 PM-Scl,
          or double stranded DNA (Using ELISA with standard cutoffs);
     (c) anti-microsomal, anti-cardiolipin, or RF greater than or equal to 1:80.

10. Raynaud’s phenomenon, evidenced by a physician-observed two (cold-related) color change; as a
      progression, or by physician observation of evidence of cold-related vasospasm, or by; a physician
      observation of digital ulceration resulting from Raynaud’s phenomenon.

11. Myalgias, defined as tenderness to palpation, performed by a physician, in at least three muscles, each
      persisting for at least six months.

12. Dry mouth, subjective complaints of dry mouth accompanied by decreased parotid flow rate using
      Lashley cups with less than 0.5 m.l per five minutes. 
     
      [Exclusion:  drugs known to cause dry mouth]

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  Lupus Criteria

The following information is reprinted from the MDL-926 Settlement booklet.  This Lupus criteria is applicable
for both the MDl-926 and Dow Settlements.
 

III Lupus (SLE)

A claim for SLE must include a diagnosis of SLE (lupus) made by a board-certified rheumatologist based upon personal examination of the patient.  [Exclusion: mild lupus (SLE not requiring regular medical attention including doctor visits and regular prescription medications)]  Supporting medical documentation must affirmatively reveal that at least four of the following 11 criteria are present:

Criterion                    Definition

1.      Malar rash                 Fixed erythema, flat or raised, over the malar eminences, tending to spare the nasolabial
                                   folds.

2.      Discoid rash               Erythematous raised patches with adherent keratotic scaling and follicular plugging;
                                   atrophic scarring may occur in older lesions.

3.      Photosensitivity         Skin rash as a result of unusual reaction to sunlight, by patient history or
                                   physician observation.

4.      Oral Ulcers                Oral or nasopharyngeal ulceration, usually painless, observed by a physician.

A   Arthritis                     Non-erosive arthritis involving two or more peripheral joints, characterized by tenderness,
                                   swelling, or effusion [exclusion: erosive arthritis].

6.      Serositis                     (a). Pleuritis—convincing history or  pleuritic pain or rub heard by a physician or evidence
                                          of pleural effusion, 
                                         
                                          or
                                  
                                   (b). Pericarditis—documented by ECG or rub or evidence of pericardial effusion.

7.      Renal                         (a). Persistent proteinuria greater than 0.5 grams per day or greater than 3+
Disorder                           if quantitation not performed
                                         
                                          or
                                  
                                   (b). Cellular casts—may be red cell, hemoglobin, granular, tubular, or mix.

8.      Neurologic                 Seizures—in the absence of offending drugs or known metabolic derangements,
Disorder                     e.g., uremia, ketoacidosis, or electrolyte imbalance.

9.      Hematological            (a). Hemolytic anemia—with reticulocytosis, or
Disorder                     
                                    (b). Leukopenia—less than 4,000/mm total on two or more occasions, or
                                   
                                    (c).   Lymphopenia—less than 1,5000/mm on two or more occasions, or

                                          (d). Thrombocytopenia—less than 100,00/mm in the absence of offending drugs

Immunologic               (a). Positive LE cell preparation or Anti-DNA: antibody to native DNA in abnormal titer,
Disorder                            or                     
                                    (b). Anti-SM:  presence of antibody to Sm nuclear antigen, or

                                    (c). False positive serologic test for syphilis known to be positive for at least 6 months and
                                          confirmed by Treponema pallidum immobilization or fluorescent treponemal antibody
                                          absorption test.

 Antinuclear                An abnormal titer or antinuclear antibody by immunofluorescence or an equivalent assay
                                    at any point in time and in the absence of drugs know to be associated with
                                    “drug-induced lupus” syndrome

Compensation Levels: 

A.  Death resulting from SLE, or sever chronic renal involvement manifested by a glomerular filtration rate of less
      than 50% of the age-and gender-adjusted norm, as measured by an  adequate 24-hour urine
      specimen collection.

B. SLE with involvement of one or more of the following:  glomerulonephritis, seizures in the absence of offending
     drugs or know metabolic derangements.  Lupus Psychosis, myocarditis, pneumonitis, thrombocytopenic purpura,
     hemolytic anemia (with hemoglobin of 10 grams or less), severe granulocytopenia (with a total white cell count
     less than 2000) or mesenteric vasulitis.

C. A diagnosis of lupus in accordance with the above criteria that does not involve the findings in A or B above.  
     (Default compensation level.)         

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 Scleroderma Criteria

 
The following information is reprinted from the MDL-926 Settlement booklet.  This Scleroderma  criteria is applicable for both the MDl-926 and Dow Settlements.

II.   Scleroderma (SS)

       A claim for scleroderma must include a diagnosis of systemic sclerosis/scleroderma made by a
       board-certified rheumatologist based upon personal examination of the patient. 
       [Exclusions:  localized scleroderma] Supporting medical documentation must affirmatively reveal
       that the major or at least two of the minor criteria listed below are present:

 A.  Major criterion:  Proximal scleroderma—systemic thickening, tightening, and induration of the skin
       of the fingers and the skin proximal to the metacarpophalangeal or metatarsophalangeal joints.  The
       changes may affect the entire extremity, face, neck, and trunk (thorax and abdomen).  Description
       of this criterion is adequate if the board-certified rheumatologist records that physical examination of
       the patient revealed scleroderma skin thickening, and adequately describes the parts of the body
       where that thickened skin was found.

B.  Minor criteria: 

      1.  Sclerodactyly:  Above-indicated skin changes limited to the fingers.
     
      2.  Digital pitting scars or loss of substance from the finger pad; Depressed areas at tip of finger or loss
           of digital pad tissue as a result of ischemia.

      3.     Bibasilar pulmonary fibrosis:  Bilateral reticular pattern of linear or lineonodular densities most pronounced in
           basilar portions of the lungs on standard chest roentgenogram; may assume appearance of diffuse mottling
           or “honeycomb lung. These changes should not be attributed to primary lung disease.

Compensation Levels: 

A.                           Death resulting from SS, or severe chronic renal involvement manifested by a glomerular
           filtration rate of less than 50% of the age- and gender-adjusted norm, as measured by an
           adequate 24-hour urine specimen collection.     

B. Clinically significant cardio-pulmonary manifestations of scleroderma or proximal scleroderma
      on the trunk (thorax and abdomen).

C.  A diagnosis of scleroderma in accordance with the above criteria that does not involve the
      findings in A or B above.

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Polymyositis / Dermatomyositis Criteria

The following information is reprinted from the MDL-926 Settlement booklet.  This Polymyositis/ Dematomyositis criteria is applicable for both  the MDL-926 Revised and the proposed Dow Settlement.

IV. Polymyositis (PM)/Dematomyositis (DM)

A claim for polymyositis or dematomyositis must include a diagnosis of the disease made by a board-certified rheumatologist based upon personal examination of the patient.  Supporting medical documentation must affirmatively reveal that the following criteria are present:

-For polymyositis, the first four criteria without the rash;

-For dematomyositis, three of the first four criteria, plus the rash (#5).

Criteria:
 

1. Symmetrical proximal muscle weakness;

2. EMG changes characteristic of myositis including

    (a) short duration, small, low-amplitude polyphasic potential,
    (b) fibrillation potentials,
    (c) bizarre high-frequency repetitive discharges;

3. Elevated serum muscle enzymes (CPK, aldolase, SGOT, SGPT,  and LDH);

4. Muscle biopsy showing evidence of necrosis of type I  and II muscle fibers areas of degeneration and
    regeneration of fibers, phagocytosis and an interstitial or perivascular inflammatory response;

5. Dermatologic features including a lilac (heliotrope), erythematous, scaly involvement of the face, neck, shawl
    area and extensor surfaces of the knees, elbow and medial malleoli, and Gotton’s papules. 

Compensation Level: 

   l confirmed PM/DM diagnoses will be compensated at the GCTS/PM/DM—A level.

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