The last one that I have or that we will

15 open it to the audience if there is anyone else is

16 Nora W. Coffey, President, Hysterectomy Educational

17 Resources and Services Foundation (HERS).

18 MS. COFFEY: Good afternoon. I am Nora

19 Coffey, President of the Hysterectomy Educational

20 Resources and Services Foundation, a national

21 nonprofit women's health education organization.

22 HERS is also the repository of thousands of reports

23 from women regarding the treatment they receive and

24 have had suggested to them by physicians.

25 I am going to truncate what I intended to

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1 say today in the interest of time, but I am still

2 going to I guess rush through.

3 Research of the medical literature

4 revealed that UAE was a surgery that had been

5 performed on a small number of women for postpartum

6 hemorrhage initially and at risk of death. It is

7 now being performed on women notably absent from

8 any danger to life and often even lacking the

9 minimal symptoms for which any treatment might

10 rationally be suggested.

11 Since UAE first emerged, the pool of so-called

12 qualified UAE candidates has shrunk as the

13 obvious dangers of performing it in certain women

14 has become apparent, but the number and seriousness

15 of adverse effects has mounted and now sits well

16 outside the promised no complications, and from the

17 hint that there might be pain as a result for a

18 very short time requiring the possibility of

19 hospital admission for treatment, we now know that

20 many or most do have pain and others have

21 persistent, some severe pain for months and even

22 years later as a permanent complication.

23 All this has been learned, not from

24 laboratory science before exposing large numbers of

25 women, but from the ill effects suffered by women

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1 who expected that this was an easy and trouble-free

2 solution to the problems that some, but not the

3 majority, of women encounter from fibroids.

4 Our office continues to receive calls from

5 women unsuspecting of these facts including one who

6 doctor told her that he would perform the procedure

7 on her. When she asked how many UAE he had

8 performed, he said he hadn't performed any, but he

9 had read about it, and he was sure that he could do

10 it.

11 Another woman who underwent UAE reported

12 that she had developed a foul vaginal odor,

13 obviously not only to herself, but to others. She

14 had an infection. When it was exposed at surgery,

15 had appeared to simmer for months, and had caused

16 adhesion of the bowel to the uterus and other

17 organs, requiring that a specialist come in mid-operating

18 procedure, and there are many other

19 reports. I am going to skip over the women's

20 reports, although I think they are really

21 important, and I wish I had time to show them.

22 You all know of similar problems which

23 have not yet appeared in the journals, although

24 none of us know how large the total numbers are or

25 will become from this experimental misadventure.

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1 Uterine artery embolization has already

2 caused deaths, hysterectomies, infections,

3 cessation of menstrual periods, rehospitalization,

4 and other damage that was unexpected by women, all

5 in a scant few years.

6 This leads to the expectation that there

7 is more in terms of numbers and additional

8 consequences not yet identified. We ask then of

9 the FDA the following:

10 If you have the authority to confer

11 approval on a surgical procedure, and thus confer

12 its legitimacy, although there are no standards

13 that exist for doctors, materials, or other

14 instrumentation, and no uniform procedure to

15 assess, that you exercise your authority and

16 responsibility to require that vendors, doctors,

17 and other proponents for widespread use of UAE curb

18 advertising and publicity which makes it appear

19 that all the answers are in and that they are

20 uniformly positive.

21 There is a public health danger posed by

22 the self-promoting web sites and publicity in media

23 generated by doctors and other commercial

24 interests, such as the manufacturers, inventors of

25 devices who advocate for UAE.

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1 Unfortunately, the biological sequela

2 arising as a result of this procedure will be

3 learned on the bodies of women, many of whom, as in

4 the case with hysterectomy, have no medical need

5 for any treatment whatsoever, and the argument that

6 hysterectomy is worse does not make UAE better,

7 only different in its dangers, which are as yet

8 largely unknown.

9 What are the lifetime sequela of the long-term

10 effects on ovarian function, endocrine

11 function, and the implications for vascular and the

12 immune systems?

13 If the permanence of artery occlusion

14 causes concerns, there are equal concerns lest the

15 blockade degrade or partially separate and drift.

16 What women need is a return to laboratory

17 science in order to identify the reasons women

18 develop fibroids, so that their arteries, uteri,

19 and other organs not be targets of interference and

20 demolition.

21 A name change, changing from uterine

22 artery embolization to UFE, uterine fibroid

23 embolization, will not serve women well. In fact,

24 it raises more questions about the problems we have

25 not yet read about in the journals and those yet to

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1 come.

2 Calling it fibroid embolization rather

3 than artery embolization is an evasion and

4 ultimately misleading to women because it is, in

5 fact, the arteries that are embolized.

6 If clinical trials do proceed, and

7 apparently they are already in progress, we suggest

8 that women be provided with the following: Full

9 written disclosure of the known risks and adverse

10 consequences of UAE. An opportunity to ask

11 questions in writing, which doctors will respond to

12 in writing, and signed and date.

13 An adverse events reporting form should be

14 provided to the woman undergoing embolization, in

15 triplicate, with a copy to go to her doctor, a copy

16 to go to the FDA, and a copy for the patient.

17 Disclosure should include deaths,

18 sterility, radiation to the ovaries, infection,

19 loss of menstruation, hematoma, allergy to contrast

20 material, failure to shrink fibroids or resolve

21 symptoms, regrowth of fibroids, growth of new

22 fibroids, post-embolization syndrome, damage to

23 nerves, embolization of the wrong arteries, damage

24 to the blood supply to the ovaries, and loss of

25 libido, loss of sexual feeling.

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1 Women should be told of all of the

2 alternatives to hysterectomy including no treatment

3 at all, myomectomy, and hysteroscopic resection of

4 submucosal fibroids.

5 Currently, a large number of doctors tell

6 women that the only option they have available to

7 them is hysterectomy or UAEE, which is certainly

8 not the case.

9 Thank you.

10 DR. BLANCO: Thank you very much.

11 Is there anyone else in the audience that