Fw: An approach that integrates patient education and informed consent in br...

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----- Original Message -----

From: " Kathi " <pureheart@...>

Sent: Monday, September 23, 2002 11:49 PM

Subject: Re: An approach that integrates patient education and informed

consent in br...

> please remove identifiers...

> This article appears to be a step in the right direction...I would also

> like to see each patient, and family member/partner given, weeks in

> advance of the procedure, the FDA web info as well as the NCI research

> about implant recipients having a higher incidence of brain/lung cancers

> and suicide, Dr. Brawers article on Amelioration of Symptoms after

> implant removal, and the FDA's research on implant women having higher

> incidences of fibromyalgia and antibodies to collagen in asymptomatic

> patients, along with recent research from Yonsei about silicone

> injections causing pulmonary embolisms, ect. ect. ...and then I would

> like to see it standardized so that EVERY woman wanting implants gets

> the same information ...and then I would like to see the FDA set a

> standard for clinical trial data submitted for product approval,

> requiring manufacturers to meet criteria for LONG TERM SAFETY and

> TRUTHFUL complication rates which include baseline exams/bloodwork and

> follow up after device removal....Included in the long term follow up

> after implant removal I would like to see how effective mammograms are

> after multiple breast surgeries....

>