DCCKKA028727

Attorney/Client Privilege

(hand noted to DMH, Jane J and Lois Duel)

The Maryland Women’s Health Coalition held a public meeting on January 9 in Baltimore, Maryland, attracting only about 25 attendees.  The Maryland Women’s Health Coalition is strongly anti-implant, and the meeting was chaired by Joan Pitkin, Maryland House of Delegates, a known implant critic who testified at the hearings.

The purpose of the meeting was to discuss the legislation Pitkin is introducing to ban implants in the state of Maryland.  Pitkin also is calling for a national registry of breast implant recipients.

Attending from the FDA was Dr. Helena Breslawac, Investigational Devices.  She is important for two reasons:

1)    She said she has briefed Kessler on the increase in anecdotal reports about the link between implants and autoimmune disease

2)    She said she is involved in selecting a rheumatologist to supplement the existing Advisory Panel.

We think she may be biased against implants.  Some of her comments from the meeting follow:

·         “I briefed Dr. Kessler about the increase in anecdotal reports about the link between implants and autoimmune disease…this was just information, not specifically a study.”

·         “The PMAs were inadequate and inconclusive.”

·         “This is the most difficult issue the FDA has faced…we have a divided staff…the men (in FDA) feel like they are walking on eggshells—there is a conflicting role between the FDA and informed choice.”

·         “”There is no way to predict whether implants lead to autoimmune disease.”

·         “We are not dismissing autoimmune link but must await further review.”