I had TUMT twicewith about the same early results. Nevertheless, things got
worse in 6 weeks rather than better.

Bill

There is more than one technique for microwave, can you
give a little more detail? I am interested in this for
myself because it seems to me to be less violent than laser.
But if it doesn't last...

they run an antenna up the pecker and a temp probe up you annus to touch the
prostate. The computer heats the prostate and keeps the pecker tract cool
with cool water while some of the prostate is vaporized. The only mild
feeling was a need to urinate during the procedure. I have talked to all
ages of men who had this done and was told to go for it. I had sex at the
14th day. Same good feeling, fwd ejaculation etc. 2 weeks before the
microwave they used a scope to check the blockage etc.

Jack,

It is too late for you but I would like to repeat this message ( which is
available on Google)  for the benifit of anyone considering TUMT. Two weeks
is not enough time to know what the outcome will be. I had TUMT in 96 and
had serious burns which I did not know about for several weeks. The scar
tissue left over from the TUMT burns caused me problems for several years.
This past January I had the scar tissue removed and the opening restored and
improved by PVP.

Laserscope flaunts PVP as being "non-invasive". Don't believe it. However,
after several weeks of recovery I was able to say that it worked for me. I
am happy with the final results, unlike TUMT.

The following articles have all been posted before so if you have seen them
I appologize for using the band width. If you are considering TUMT and have
not read them, you owe yourself the time to read them.

I don't mean to imply that there are not some folks out there that are happy
with the TUMT results. I don't know how many you talked to but find it hard
to believe that it was a significant number if you found no unhappy campers.
In the study group that I was part of, more than half withdrew to seek other
treatments. Those that withdrew were not counted in the final tally and the
procedure made it through the FDA scrutiny. It never should have been
approved if people like me were actually considered.

OK. This is what the FDA found in October 2000. The figures now are much
worse and very difficult to uncover.

FDA Public Health Notification:
Serious Injuries from Microwave Thermotherapy for Benign Prostatic
Hyperplasia

(You are encouraged to copy and distribute this information)

October 11, 2000

Dear Colleague:

This is to notify you of the potential for serious thermal injury and
related complications associated with the use of microwave energy to treat
benign prostatic hyperplasia (BPH), and to provide information that can help
avoid these complications. Although the use of microwave thermotherapy for
the treatment of BPH has been demonstrated to be safe and effective, and
more than 25,000 procedures have been performed, we are concerned about some
unexpected procedure-related complications that have occurred since the
marketing of these devices.

Currently marketed devices include the Prostatron (Edap Technomed, Inc.) and
the Targis System (Urologix, Inc.). Dornier Medical Systems, Inc. has
received approval to market their UroWave System but is not yet marketing
it. We are working with the manufacturers to ensure that labeling and
training programs address these complications.

Nature of the Problem

Since 1996, we have received reports of 16 thermal injuries related to
microwave thermotherapy systems. Of these, 10 resulted in fistula formation
and 6 resulted in clinically significant tissue damage to the penis or
urethra. These injuries may not be apparent at the time of treatment, and
may take hours or days to develop. (Note that the original labeling for
these devices did not list fistula formation as a procedure-related
complication.) The reported injuries have required colostomies, partial
amputation of the penis, and/or other therapeutic interventions.

We have identified several factors that may have contributed to the injuries
noted:

 a.. Incorrect placement or undetected migration of either the treatment
catheter or the rectal temperature sensors;
 b.. Failure of the physician to remain with the patient throughout the
entire treatment duration;
 c.. Failure to pause treatment when the patient is communicating serious
pain;
 d.. Oversedation of the patient, which compromises his ability to
communicate pain;
 e.. Treatment of patients who have undergone prior radiation therapy to
the pelvic area;
 f.. Treatment of patients whose prostate sizes are outside the ranges
specified in the labeling; and
 g.. Leakage from the balloons used to retain either the urethral catheter
or the rectal temperature sensor in the correct anatomical position;
Recommendations

 1.. When considering a patient for microwave thermotherapy for BPH, ensure
that he meets the device's indications, including the criteria for eligible
prostate size indicated for the specific system being used. Additionally, it
is important to verify that the patient has not had prior radiation therapy
to the pelvic area, as these patients are at increased risk of rectal
fistula formation. Furthermore, the labeling of each device lists specific
patient populations for which safety and effectiveness of this therapy are
unknown (e.g., those with prostate cancer).
 2.. When discussing the procedure with the patient, it is important to
ensure that he understands the risks and benefits listed in the labeling of
the specific device. He should also understand the duration of the
procedure, the level of pain or discomfort that should be considered normal,
the importance of telling the physician of any unusual pain during
treatment, how to operate any emergency stop button, and the need to remain
as still as possible during treatment.
 3.. Carefully follow the instructions for use provided with these
microwave systems. Note that they require the physician to continually
supervise the procedure throughout the entire treatment period. The
physician must (1) verify that the retention balloons of the urethral
catheter and rectal temperature sensor probe are free of leaks, and (2)
confirm the placement of the urethral catheter and rectal temperature sensor
using acceptable methods (e.g., direct visualization, ultrasound imaging)
both prior to treatment and other specified times consistent with the
manufacturer's recommendations. Either patient movement or component
breakage may cause migration of a properly placed urethral catheter or
rectal temperature sensor.
 4.. Be careful not to oversedate the patient. As patient perception of
pain is an important safety mechanism to ensure that the heating of the
tissue is not excessive, general or spinal anesthesia should not be used.
 5.. Closely monitor the patient and the equipment throughout the entire
treatment, and manually pause treatment if the patient complains of
excessive pain or anything unusual occurs.
Background

Microwave thermotherapy systems are intended to heat the prostate, resulting
in the necrosis of periurethral prostatic tissue, to provide relief of
urinary symptoms in patients with obstructive BPH. These devices heat the
prostate to therapeutic levels using microwave energy delivered by an
antenna contained within a specially designed urethral catheter. The
catheter is designed so that when the balloon is seated at the neck of the
bladder, the active portion of the antenna is positioned within the
prostate. To prevent overheating, the systems circulate cooling fluid
through the urethral catheter to protect the urethral tissue from excessive
heat and automatically vary microwave energy output during treatment based
on information supplied by temperature sensors placed posterior to the
prostate within the rectum. Treatment may last from 30 to 60 minutes.

Because the catheter and/or the rectal temperature sensors can migrate
during treatment, and because the correct placement of both of these
components is critical for safe and effective treatment, the labeling for
all these devices instructs the treating physician to: (1) verify that the
urethral catheter (and rectal temperature sensor probe, if applicable) has a
working retention balloon prior to placement, and (2) verify the proper
position of both the urethral catheter and the rectal temperature sensors
prior to and at specified time intervals consistent with the manufacturer's
recommendation for treatment. These requirements are intended to help ensure
that catheter or rectal temperature sensor migration does not occur in a
manner which would cause undetected excessive heating of surrounding tissues
or the delivery of therapeutic heating levels to areas of the body that are
not intended to receive treatment. The labeling for microwave thermotherapy
devices also instructs the treating physician to monitor the equipment and
patient during treatment, and manually reduce or pause the microwave power
if the patient experiences excessive pain or extreme heating is observed.

Reporting Adverse Events to FDA

The Safe Medical Devices Act of 1990 (SMDA) requires hospitals and other
user facilities to report deaths and serious injuries associated with the
use of medical devices. FDA is interested in additional data on adverse
events involving the use of microwave thermotherapy systems. When submitting
a report, please identify the treatment protocol and catheter type, if
known. Healthcare providers that are employed by facilities that are subject
to FDA's user facility reporting requirements should follow the reporting
procedures established by their facilities. All other providers may submit
their reports to MedWatch, FDA's voluntary reporting program. The reports
can be submitted by phone at 1-800-FDA-1088; by fax at 1-800-FDA-0178; by
mail to MedWatch, Food and Drug Administration, HF-2, 5600 Fishers Lane,
Rockville, Maryland 20857, or online at
www.accessdata.fda.gov/scripts/medwatch.

Getting More Information

If you have questions regarding this letter, please contact Laura Alonge,
Office of Surveillance and Biometrics (HFZ-510), 1350 Piccard Drive,
Rockville, Maryland 20850, by fax at 301-594-2968, or by e-mail at
phann@cdrh.fda.gov. Additionally, a voice mail message may be left at
301-594-0650, and your call will be returned as soon as possible.

All of the FDA medical device postmarket safety notifications can be found
on the World Wide Web at http://www.fda.gov/cdrh/safety.html. Postmarket
Safety notifications can also be obtained through e-mail on the day they are
released by subscribing to our list server. To subscribe, send an e-mail
message to fdalists@archie.fda.gov. In the body of the text, type "subscribe
dev-alert".

Sincerely yours,

David W. Feigal, Jr., MD, MPH
Director
Center for Devices and Radiological Health
Food and Drug Administration

(Updated October 11, 2000)

Articles in JAMA

This comes from FDA. >these devices did not list fistula formation as
aprocedure-related> complication.) The reported injuries have
requiredcolostomies,> partial> amputation of the penis, and/or other
therapeuticinterventions.> We have identified several factors that may have
contributedto the> injuries  The Following is from JAMA:  Microwave Therapy
Warning  Jane E. Henney, MD  The FDA warns physicians that treatment of
benign prostatic hyperplasia(BPH) with microwave energy has been associated
with serious thermalinjuries and related complications. Ten of the 16
injuries reported in thelast 4 years resulted in fistula formation and six
in clinically significanttissue damage to the penis and urethra. The
injuries have requiredcolostomies, partial amputation of the penis, and
other therapeuticinterventions. The agency has identified the following
factors that may have contributed tothe reported injuries: incorrect
placement or undetected migration of thetreatment catheter or the rectal
temperature sensors; failure of thephysician to remain with the patient
throughout the treatment; failure topause treatment when the patient is
communicating serious pain; oversedationof the patient that compromised his
ability to communicate pain; treatmentof patients who have undergone prior
radiation therapy to the pelvic area;treatment of patients whose prostate
sizes are outside the ranges specifiedin the labeling; and water or air
leakage from the balloons that retain theurethral catheter and the rectal
temperature sensor, respectively, in thecorrect anatomical position. AUTHOR
INFORMATION Jane E. Henney, MDCommissioner of Food and Drugs Written
inquiries may be directed to Jane E. Henney, MD, Commissioner ofFood and
Drugs, HF-1, Room 14-71, 5600 Fishers Ln, Rockville, MD 20857.     Another
personal story By - Greg H. Albers I had the targis on 4-22 -99 DO NOT EVER
DO IT! I had a 20 gram prostate on1 mg of Hytrin for two years and doing
fine.Went to Dr. Segura and Dr. Dechetat Mayo in Rochester. They told me I
had to do it. It was just greed I foundout. I had two hours. At 43 minutes I
demanded the technician turn it off.Shouldn't without the Dr.'s permission
and he was busy with two residentsDoing three procedures.  He was not to be
disturbed. For the next 25 minutes Iscreamed for hospital security. At 63
minutes Segura came in and said I wasmaking too much noise knocked me out
and did it another hour. I could notwalk for 24 hours, the urethra was one
minute from being burned off thebladder.  The bladder had a tennis size burn
that my doctors wereamazed didn't rupture from the catheter.  The urethra
was all burned up.  Ihad a 20 gram prostate. It is 50% gone the rest is
cooked, hemmoraged and allsmooth muscle and nerves are burned.  When it is
done it leaves a cautherizedwall of burned tissue even if done right.  The
secretions from the prostatecan never escape and all the secreting ducts are
destroyed along with thechannels for the sectetions to get to the urethra
openings.  The obturatornevrve under the bladder was burned. The sheath is
gone on the nerve.  Thelegs do not work. I was on a walker for 1 month, two
canes 6 months and at 18months on a cane for life. I had a donut for 9
months, no erection, noejaculation and a hernia on the right side from the
nerve damage and muscledamage.  I got  30 blood clots and bled if I lift
over 20 pounds.  I amrunined for life. A dry ejaculation is horrible.  Don't
do it for a minute.I would have a pubic catheter before a TURP or TUMT.
Never ever do a TUMT.If you do a TUNA just allow them to do two spots not
four on each side.  Haveonly the minimum and shave just a little off.  Again
you will looseejaculation from the wall of tissue that is cauterized from
the procedure.However the rest of the prostate will be untouched. Mayo said
so what get apump and get over it.  Urologix is no help.  In the
bibliography of themachine they list articles on the procedure.  75% do not
exist and even thecompany cannot provide them.  It is bogus and a cruel
procedure.  You willloose all ejaculation and the prostate will never
secrete again. I have goneto universities and clinics across the U.S.A.  I
have spent $25,000 of mymoney trying to get functions back.  I am told there
is nothing to be done.It is burned.  The TUMT both Targis and Prostatron are
horrible. Never allowit.  If you do a TUIP only do one minor cut not two and
not four. Go to theU of Mich at Ann Arbor.  They do 15 TURPS a  years total.
Others do 20 a monthper doctor.  They say 50% of all prostate troubles are
not prostate butbladder the same as women.  Get many opinions.  Mayo at
Rochester inmy belief is one of the worst clinics in the U.S.A. Targis says
they onlyhave 3.9% of loss of ejaculation.  However it is almost 100%.  They
will notprovide any information  on what the 3.9% means. It must mean that
if you have1 drop you are not counted as a loss. I had the worst doctor,
uncaring and amiserable mean individuals to do this to me.  Run from it.
The only reasonthey do it is because they can have a nurse do it and they
can double bill thetime. They buy into the equipment and need to pay for it.
The surgical nursetold me to keep quiet she was busy with paper work and
would not get thedoctor.  I was lied to repeatedly at the Mayo Clinic by
Segura and Dechet. TheAUA scoring is also bogus.  Have a 15 year old take it
and he will beA 20 scores.  Remember it is based on the amount of fluid you
take in.  YouMake one cc of urine each minute. I had the flow test and had a
60ccretention.  However they waited 45 minutesafter the test to do the
cysto.  Imade 45 cc during the time.  Then they said I was retaining too
much.  Howevereven after a TURP you have 50 to 100 cc. Remember that after
theseprocedures the internal sphincter is gone.  You will void at least 4
times anight forever.  On Hytrin you will not. So stay on it. i get up
sometimes 11times a night now because the bladder neck is gone and the
internalsphincter.  The doctors on the internet have a financial interest in
Targis orthey would not advise it.  Greg H. AlbersRes;
507-645-5055Email:ghalbers@aol.com++++++++++++++++++++++++++++++++++++++++++
++++++++++++++++++++++++++  MY STORY

November 1, 1996

I am Burr Cook of 44 Phelps Street, Lyons, New York 14489. My phone is
(315)946-3346.

In January 1995 I volunteered for and participated in an FDA study called
Urologix, Inc. T3 System (later became known as Targis) for Treatment of
Benign Prostatic Hyperplasia with sham Control Arm (Pr. 940809-A [96660]).
My urologist was the study investigator at The University of  Rochester
Medical Center, Strong Hospital. On April 17,  1995 I had the treatment and
found out some time later that I was part of the 25% that were in the
control group. The catheter was inserted and the machine turned on for an
hour, but, known only to the machine at that time, the actual microwave was
not turned on. I was told beforehand that there would be no pain involved.
Only minor discomfort from the catheter. This turned out to be relatively
true for this occasion, although the pain was a little more than I expected.
Even though I was a sham I experienced some temporary relief due to the
stretching.

The equipment used was made by Urologix Inc. of Minneapolis.

The study WAS reviewed by the Western Institutional Review Board (WIRB) of
Olympia, Washington. At the time I originally wrote this report the
equipment was not yet approved by the FDA. This equipment is similar to, but
is not, the one known as Prostatron. It uses Trans Urethral Microwave (TUMT)
in much the same way, however.

Several months later, after the results were in, I was offered the treatment
for real. The original agreement was that this would be done, for free, for
us in the control group. I saw no reason not to go ahead and agreed.

On March 25, 1996 I had the treatment again. This time I had unbearable pain
which started or at least got much more severe a few days after the
treatment. For at least three weeks my burning

pain in the rectal genital area  was so severe that, for the first time in
my life I considered suicide. I had some angry words with the urologist on
several occasions during that time and may have damaged our line of
communications. I felt that I should have been in the hospital during that
period and that I was way under medicated. Since they made a big deal in
their advertising about not needing pain meds, they would give me none.
Fortunately I obtained some Hydrocodone from a friend (don't tell the cops,
I got it from Rush's housekeeper) who had some left over and it helped a
little.

At three months following the treatment I was still unable to have sex and
still had pain and bleeding.

One thing that bothered me was that the Urologists at University of
Rochester medical Center went to great lengths to find other reasons for my
problems. They told me that I have a slight Hernia, which I have actually
had for long time and still have. They have blamed it on everything but the
procedure. And that is what they are reported to the FDA. I volunteered for
the study and did it with my eyes open, but it pisses me off to have so much
trouble and have the information not inputted into the study.

On July 24th, 96 at my internists request I saw a second urologist, a friend
of his from the Urology group that just did my PVP. This doctor scoped my
bladder and prostate and informed me that he saw a large blister in my
urethra. He informed me that he would write a letter to The U of R Med
Center, which he did, and told me that they would treat the problem. In the
study agreement, the Medical Center agreed to treat all side effects for
free.

During my visit to the Center on Sept. 17, 96. The Urologist did a very
lengthy ultrasound and pronounced all of my symptoms to be from other causes
and told me to come back in six months. When I asked about the blister that
the private urologist had found, he informed me that since he (the Urologist
outside of the study) had found it, it is up to him to treat it. I
complained about paying the expenses for my complications. When I
volunteered I was told that it would all be free.

To summarize, prior to the T3 (Targis) treatment my main complaint was
frequency and a weak stream. Also, I experienced  difficulty in starting my
urine flowing and a lot of starting and stopping. Those symptoms continue
getting worse. My Symptom score is significantly higher after the treatment
than before the treatment.  A higher score means more symptoms.

It is also troubling to me that at the time that I actually had the
treatment I could have been told that it was relatively ineffective and
known to have side effects. That information was deliberately withheld from
me. Had I known what the investigators knew I most likely would not have
submitted so readily. Unfortunately I did most of my research after instead
of before.

Respectfully,

Burr Cook

Letter to the review board which is supposed to be impartial but was not.

November 23, 1996

Western Institutional review Board 3535 7th Ave. SW

Olympia, Wa. 98502-5010

CC:     XXXX, FDA, Washington, DC

           Drs. Davis and Maher, U. of R. Med. Ctr. Rochester, NY

           XXXX, Esq. U. of R. Legal Counsel

Attention: Mr. XXXXX,

I have enclosed a statement, dated November 1, 1996 which I copied from the
prostatitis web page at <http://www.prostate.org> . This document explains
where I am and what I have asked for. Also, I have enclosed the response
from The U. of R. Legal Dept. which denies my request.

It has been three months since Dr F. told me that I had a blister in my
prostate that needed treatment. To date no one has treated it. I  informed
Dr. M. that I did not feel that the people involved in the T3 study have my
best interest in mind.

Dr. M. suggested that I take a drug, Cardura, for my urinary problems.

I don't see how that would treat the blister. I realize now that by taking
prostate medicine or accepting outside treatment I would disqualify myself
from taking part in the study. I do not wish to withdraw from the study. At
this point that is the last thing I wish to do. I do not wish to take the
Cardura and further I am fearful of

being treated by Dr. M. or Dr. D. or anyone else involved with the T3 study,
they are covering something up and I don't have faith that they want to help
me.

I am still experiencing some serious burning after urinating. I am asking to
be treated, for these side effects of the T3 treatment, by another doctor. I
am also asking to be reimbursed for the ever mounting medical expenses that
have resulted directly from this treatment.

Sincerely,

Burr Cook

From old posting to News Group:

From: Burr Cook

Newsgroups: sci.med.prostate.bph

Subject: Re: TUMT

Date: Wed, 14 May 1997 00:51:23 -0300

Hi,

I had TUMT one year ago and have had a continual worsening of symptoms

ever since.

The problems are mainly sexual and include retrograde ejaculation.

I have been researching this procedure very intensely and have

discovered that most of it's selling points are outright lies. The

European studies are quoted most. They must feel that we are

incapable of finding the results of these studies. They failed to

tell me that prostatron was banned in France after the studies turned up
some very serious side effects.

I was part of an FDA study of T3. When I started having problems I was

simply removed from the study despite my objections. I defy anyone to

find out about my experience from anyone involved. They are covering up some
pretty nasty stuff.

I would be glad to discuss my problems in more detail by email.

Please do not submit to TUMT. I was very seriously burned. The burn was
documented by an independent Urologist through Cystoscopy and CT, MRI and
ultasound. Four months after treatment I still had a blister inside.

My urinary symptoms have gotten much worse and I am considering TURP

which the TUMT was supposed to avoid. I think I could have avoided it

had I not gone for the Microwave.

I would like to hear from others with experience on this, good or bad. I
think it needs a lot more discussion.

When I entered the study I was told that 440 people were also in the

study 40 of which were controls. I was originally one of the 40 and had to
have the procedure a second time with the machine plugged in. Oddly, when I
requested to see the results of the study, I was given results on 28
subjects. What happened to the other 412 patients? Did they all turn out
like me?

If you are considering this treatment, I believe that you owe it to

yourself to come to my home and talk to me first. Wherever you live it

will cost less than the procedure.

I am very very serious. Anyone with BPH that is suffering is invited to be a
guest in my home. I will introduce you to my Doctor who will verify what I
am saying. I want you to see that I am not some kind of nut case. You may
learn much more by talking to my wife. I will submit to any kind of
diagnostic testing to prove my point if it will save one person from going
through this.

Hoping this helps someone,

Burr Cook

To report problems caused by urological devices:

 For VOLUNTARY reporting

 by health professionals of adverse

 events and product problems

Contact:

MEDWATCH

5600 Fishers Lane

Rockville, MD 20852-9787

Request: FDA Form 3500 (6/93)

or send Fax to:   1-800-FDA-0178

Phone 1-800-FDA-1088

Modem 1-800-FDA-7737

Jack:

Am scheduled for a TUMT July 2.  Do you know what brand of equipment was
used for the procedure?