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Transvaginal Mesh Controversy on to FDA for Review p 4 Cleveland Clinic to Open Special Delivery Unit p 3 Innovative Gynecologic Oncology Surgery p 8 Ethics and the Maternal-Fetal Dyad p 12 Center for Specialized Women’s Health p 18 Ob/Gyn & Women’s Health Perspectives An Update for Physicians From Cleveland Clinic’s Ob/Gyn & Women’s Health Institute Winter 2011

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Page 1: Transvaginal Mesh Controversy on to FDA for Review...involve transvaginal mesh. In 2010, of the 300,000 procedures performed, 196,000 were traditional repair, 70,000 used vagi-nal

Transvaginal Mesh Controversy on to FDA for Reviewp 4

Cleveland Clinic to Open Special Delivery Unitp 3

Innovative Gynecologic Oncology Surgeryp 8

Ethics and the Maternal-Fetal Dyadp 12

Center for Specialized Women’s Healthp 18

Ob/Gyn & Women’s Health PerspectivesAn Update for Physicians From Cleveland Clinic’s Ob/Gyn & Women’s Health Institute

Winter 2011

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Page 2: Transvaginal Mesh Controversy on to FDA for Review...involve transvaginal mesh. In 2010, of the 300,000 procedures performed, 196,000 were traditional repair, 70,000 used vagi-nal

Medical Editor Marjan Attaran, MD

Marketing Melissa Raines

Managing Editor Kimberley Sirk

Art Director Anne Drago

Photographers Russell Lee, Tom Merce, Steve Travarca

Ob/Gyn & Women’s Health Perspectives is written for physicians and should be relied upon for medical education purposes only. It does not provide a complete overview of the topics covered and should not replace the independent judgment of a physician about the appropriateness or risks of a procedure for a given patient.

© The Cleveland Clinic Foundation 2011

CONTENTS

3 Special Delivery Unit to Open on Main Campus

4 Transvaginal Mesh Controversy on to FDA for Review

8 Innovative Gynecologic Oncology Surgery

11 Endometriosis Symptom Relief Methods Described in New Article

12 Ethics and the Maternal-Fetal Dyad

14 Cleveland Clinic Outcomes Reporting Shows Promise and Progress

16 REI Fellowship Program Offers Exposure to Medical and Surgical Infertility Management

17 Gynecologic Oncology Fellowship Program Shapes Leaders

18 Center for Specialized Women’s Health

20 New Dedicated Breast Surgeons

21 Selected Publications

Dear Colleagues:

Welcome to this issue of Ob/Gyn Perspectives. As 2011 draws to a close, we use

these pages to reflect on some exciting — and controversial — times in our field.

This issue leads off with a story by J. Eric Jelovsek, MD, that explains the contro-

versy surrounding the potential reclassification by the FDA of synthetic mesh for

pelvic organ prolapse. As part of a national center for the correction of problems

with transvaginal mesh, the staff at Cleveland Clinic’s Ob/Gyn & Women’s Health

Institute continues to watch this debate closely.

We also provide information about two of our popular fellowship programs —

one in Reproductive Endocrinology and Infertility, overseen by Dr. Jeffrey Goldberg,

and another in Gynecological Oncology, run by Dr. Peter Rose. Both programs

provide our next generation of doctors real-world and clinical opportunities not

only to gather knowledge, but to apply that knowledge.

Also included in this issue is a story about our pathbreaking Center for Specialized

Women’s Health. This unique center will celebrate its 10th anniversary in 2012.

In addition, we provide an in-depth review of the information contained in our

recently released Outcomes book. The full edition of the book is available online

at clevelandclinic.org/quality/outcomes.

I hope you find this edition helpful in your practice. As always, our team welcomes

your comments and feedback, and continues to value our ongoing collaborations

with you.

Sincerely,

Tommaso Falcone, MD

Professor & Chairman,

Department of Obstetrics and Gynecology

Chairman, Ob/Gyn & Women’s Health Institute

Cleveland Clinic’s Gynecology program is ranked No. 4 in the nation by U.S.News & World Report.

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Special Delivery Unit to Open on Main Campus

Cleveland Clinic is opening a Special Delivery Unit (SDU) on the main campus in early 2012 for patients whose

pregnancies are complicated by serious maternal or fetal conditions. The SDU adjoins a new Pediatric Cardiac

Catheterization Laboratory.

Both the SDU and Cath Lab are key components of Cleveland

Clinic’s Fetal Care Center, where maternal-fetal medicine spe-

cialists and neonatologists team up with pediatric surgeons

and other specialists to offer diagnosis and management from

initial consultation through delivery and the postpartum

period. Advanced practice nurses offer families support and

coordinated services throughout.

Both mother and baby also benefit from Cleveland Clinic’s

Critical Care Transport (CCT) teams, who can transfer

pregnant women with acute symptom onset to the SDU via

fixed-wing aircraft, helicopter or mobile intensive care unit

as needed. The CCT teams are on call 24/7 and can provide

acute care staff when an aircraft transport is necessary.

Fetal conditions that would call for referral to the Fetal Care

Center and delivery in the SDU include:

• Abdominal wall defects

• Congenital heart defects

• Open neural tube defects

• Congenital diaphragmatic

hernia

• Hydrocephalus and other

CNS lesions

• Kidney and urinary tract

malformations

• Twin-twin transfusion

syndrome

• Skeletal dysplasia

Expectant mothers with conditions such as adult congenital

heart disease, cancer or autoimmune disease would benefit

from delivery in the SDU. “The SDU is designed to equip

Cleveland Clinic physicians to care for any potential com-

plication, either maternal or fetal, that might occur during

pregnancy,” said Jeffrey Chapa, MD, Head of Maternal-Fetal

Medicine at the Ob/Gyn & Women’s Health Institute and one

of the doctors who helped bring the new unit into service.

“This unit will help us ensure the best possible outcomes for

both mother and baby.”

The SDU has a labor and delivery suite, a large operating

room for Cesarean sections and an advanced newborn

resuscitation and treatment room. The adjoining Pediatric

Cardiac Catheterization Lab offers immediate lifesaving

intervention for newborns with Tetralogy of Fallot, hypoplastic

left heart syndrome, transposition of the great vessels,

or pulmonary atresia.

The state-of-the-art, minimally invasive Pediatric Surgical

Suites across the hall from the SDU allow emergency proce-

dures to be performed shortly after birth.

A Level III Neonatal Intensive Care Unit offers evidence-

based care and 24/7 coverage by in-house neonatologists.

Therapeutic hypothermia, nutritional support, continuous

EEG monitoring and advanced modes of ventilation are

offered, and ECMO is available. Parents appreciate the

family-centered multidisciplinary rounds.

Other key services include a Neonatal Neurointensive

Care service geared to newborns with intractable seizures,

neurometabolic disease, neuromuscular disorders,

hypoxic ischemic encephalopathy or other neurological/

neurosurgical problems. ◆

To refer parents to the SDU at the Fetal Care Center, please call 216.444.9706 or 866.864.0430. For emergency transfers, call 877.379.CODE (2633) for mothers with ST-elevated MI, acute stroke, intracerebral or subarachnoid hemorrhage, or aortic syndromes.

Jeffrey Chapa, MD Head, Maternal-Fetal Medicine

3clevelandclinic.org /obgyn | 800.553.5056

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Transvaginal Mesh Controversy on to FDA for ReviewBy J. Eric Jelovsek, MD

4 CLEvELAND CLINIC OB/GyN & WOMEN’S HEALTH PERSPECTIvES | WINTER 2011

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COvER STORy

Over the course of a lifetime, a woman has a 7 percent chance of surgery for pelvic organ prolapse (POP). In the

recent past, synthetic mesh has become a popular option for surgical repair of prolapse. In 2004, the first commercially

available trocar-guided mesh delivery system or “mesh kit” was introduced for repair of prolapse. With relatively little

data, the kits were adopted into wide use; today, we as a profession are witnessing, and rectifying, the results of this

fast-tracked adoption of the technology.

It is estimated that 25 percent of all prolapse repairs now

involve transvaginal mesh. In 2010, of the 300,000 procedures

performed, 196,000 were traditional repair, 70,000 used vagi-

nal mesh and 34,000 used abdominal mesh.

Soon after the kits began to be widely used, safety problems

began to manifest themselves. In 2008, after about 1,000

reports from the nine surgical mesh manufacturers, the FDA

issued a Public Health Notice regarding adverse events associ-

ated with the use of surgical mesh for both stress urinary

incontinence (SUI) and POP procedures.

On July 13, 2011, the FDA released a safety communication

regarding the building concerns about the mesh. One of

the steps the FDA took in response to these concerns was

to appoint an advisory panel, which presented an update to

the FDA in early September. Panel members spoke on Sept. 8

about transvaginal mesh for POP; on Sept. 9, the panel took

up the issue of mesh slings for SUI. Twelve of the 17 panel

members were physicians: two urologists, five ob/gyns, four

urogyns and one minimally invasive gynecologic surgeon.

The panel was chaired by Dr. Tommaso Falcone, Chairman

of the Ob/Gyn & Women’s Health Institute at Cleveland Clinic.

Multiple professional societies, including the American

Urogynecologic Society (AUGS), the American Congress of

Obstetricians and Gynecologists, the Society for Urodynamics

and Female Urology and the Society of Gynecologic Surgeons,

expressed concern about the groundswell of problems specifi-

cally with surgical mesh for POP repair.

In the presentations, representatives from these societies

made it clear that two uses for mesh were being discussed —

for SUI and POP — and that two separate histories for those

two categories of products guided their recommendations.

Presenters did not recommend the blanket withdrawal

34,000

70,000196,000

POP Repair Surgeries — US Market 2010* 300,000 women

*industry source

Traditional Repair

Mesh, vaginal

Mesh, Abdominal

79,500

25,210

16,550

POP Mesh Sales 2010* Total 121,260

*US Markets for Soft Tissue Repair 2010, Millennium Research Group, Inc. All rights reserved.

Reproduction, distribution, transmission or publication is prohibited. Reprinted with permission.

vaginal Mesh Kits

Synthetic Mesh Patch

Non-Synthetic Patch

5clevelandclinic.org /obgyn | 800.553.5056

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of products from the market; rather, a case was made for

conducting premarketing studies before approval of new

products and postmarketing studies for existing transvaginal

mesh products.

In cases of mesh use for SUI, the testimony reflected the belief

that midurethral slings using synthetic mesh are the standard

of care; considerable advances in and mature research of this

application make it a continuing reliable and safe solution to

a bothersome problem.

“AUGS is not recommending the removal of mesh for POP from

the market,” said Matthew Barber, MD, President of AUGS.

“Instead, we support the judicious use of transvaginal mesh

for POP repair performed only by surgeons with appropriate

training on patients who have been fully informed of the risks

and benefits of all treatment options. Certainly, more data

is needed on the long-term safety and effectiveness of these

devices so surgeons and patients can make informed deci-

sions. Alternatively, mesh slings for SUI are the standard of

care, and AUGS does not feel any change in the current regula-

tory status of synthetic mesh for this use is warranted.”

The majority of the FDA Advisory Panel members advocated for

the reclassification of the devices for POP from Class II (Special

Controls) to Class III (Premarket Approvals). Members indi-

cated that they believed that Class III will allow for appropriate

comparison of method, for training concerns to be addressed

and additional data collection. Reclassification would involve

numerous steps and would take several years to complete.

During that time, products currently in use would remain on

the market. And, this would apply to products for POP only.

The use of mesh slings for SUI has been studied thoroughly,

and the only recommendation the panel made in this area is to

better characterize the infrequent, life-altering adverse events

that do occur.

Clinical studies are a necessity for premarket evaluation of

vaginal mesh products, which would be required by Class III

assignment. A minimum of one year of data is needed on clini-

cally important outcomes, and three to five years of follow-up

through post-market surveillance and registry information

would be appropriate. Reclassification would also allow for

assessment of reasonable assurance of safety and effectiveness

via a RCT with non-mesh control arms.

Transvaginal Mesh Controversy ConTinued

Illustration demonstrates one technique of visualizing mesh

arms to facilitate removal.

6 Cleveland CliniC Ob/Gyn & WOmen’s HealtH PersPeCtives | Winter 2011

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Before placing surgical mesh, it is imperative to keep in mind

that it is designed to be a permanent intervention for the

condition. Placing the mesh could subject the patient to

additional surgery for complications related to the mesh.

In the event that mesh must be removed, it is many times

necessary for the patient to endure multiple surgeries.

In some cases, the mesh cannot be successfully removed,

and even when the mesh can be removed, complications

do not always resolve themselves.

In the hands of a skilled surgeon, mesh presents a good

option for resolution of issues related to POP. Better outcomes

may result from the abdominal placement of mesh for POP.

Prior to surgery the patient should fully comprehend the ben-

efits and risks of all options, surgical and nonsurgical. If the

mesh option is selected, the patient should be fully informed

of the type of product used. The patient should understand

that the limited long-term outcome data on these products

should be an important consideration.

Cleveland Clinic is recognized as a center of excellence for

the removal of troublesome synthetic surgical mesh placed

for POP. We receive referrals of several patients a week, many

coming from other institutions, for consultation and/or

removal of mesh gone wrong.

In fact, the Ob/Gyn & Women’s Health Institute at Cleveland

Clinic receives calls from patients on this topic on a regular

basis. Our staff counsels and educates patients about what we

know about this evolving issue, and informs patients about

what symptoms to look for that would signal a mesh problem.

We do know that there are many women we don’t hear from —

those women in which correct placement of mesh has been

the right option in their case.

It is clear that the potential benefits of transvaginal mesh

placement to correct pelvic organ prolapse must be balanced

against an increased rate of complications when considering

treatment of POP.

The panel recommendations have been forwarded to the FDA

for its consideration. We believe that an official statement

from the FDA, and perhaps recommended action, will be

communicated to those in the ob/gyn field in the very near

future. Until then, and as always, we recommend continued

vigilance in the use of these products. ◆

For additional information, contact Dr. Jelovsek or Dr. Barber at 216.444.2488.

Top 10 Adverse Events for POP Reports

Rank Adverse Event # of MDRs Percentile Rate

1 Erosion 528 35.1%

2 Pain 472 31.4%

3 Infection 253 16.8%

4 Bleeding 124 8.2%

5 Dyspareunia 108 7.2%

6 Organ Perforation 88 5.8%

7 Urinary Problems 80 5.3%

8 Neuro-muscular problems 38 2.5%

9 Vaginal scarring (41) / Shrinkage (2)

43 2.8%

10 Recurrence, Prolapse 32 2.1%

Total number of adverse events is larger than total number of MDR reports because the majority reported more than one adverse event

Source: www.fda.gov

7clevelandclinic.org /obgyn | 800.553.5056

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Innovative Gynecologic Oncology Surgery

The patient was referred to Cleveland Clinic gynecologic

oncologists after a bilateral oophorectomy. Postsurgical

pathology, however, revealed cancer in her Fallopian tubes.

The new cancer, coupled with the patient being identified as

having mutations in her BRCA1 and BRCA2 genes, increased

the complexity of her care. The genetic mutations increased

the possibility of developing future gynecologic cancers.

The decision was made to stage the patient via minimally

invasive surgery through her umbilicus.

The patient is among an increasing number of gynecologic

oncology patients at Cleveland Clinic who benefit from

laparoendoscopic single-site (LESS) surgery. Pioneered at

Cleveland Clinic, the technique enables surgeons to use

several articulated devices through a single incision made

in the patient’s umbilicus.

Cleveland Clinic’s team approach of involving multiple

specialists can be the most important factor in long-term

survival. Gynecologic pathologists, radiologists, medi-

cal oncologists and other Clinic specialists collaborate to

provide a careful blend of accurate diagnosis, surgical skill

with the newest technology and procedures, leading-edge

radiation therapy and advanced chemotherapy.

“LESS surgery involves articulated high-definition scopes

and flexible instrumentation. The ergonomics of the tech-

nology could be cumbersome for the surgeon because of

wrist movements and discomfort,” said Pedro Escobar, MD,

Director of Laparoscopy and Robotic Surgery at Cleveland

Clinic’s Ob/Gyn & Women’s Health Institute.

8 Cleveland CliniC Ob/Gyn & WOmen’s HealtH PersPeCtives | Winter 2011

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Pedro Escobar, MD Director, Laparoscopy and Robotic Surgery Ob/Gyn & Women’s Health Institute

Future Robotic Platforms

Several devices operating through such a small incision

creates a crowded condition that can hinder delicate surgery.

A prime contributor has been the fiber-optic camera that

surgeons need to see their work. Surgeons stop using the sur-

gical instruments in order to work the camera controls, and

merely redirecting the camera tip can bump the instruments.

“Ongoing research in MIS at our institute utilizing novel

single-site robotic platforms (i.e. da Vinci® and ViKY® in

the preclinical model) is very promising and essential prior

to expanding and implementing novel robotic platforms

to human trials,” Dr. Escobar said.

Dr. Escobar uses the latest in miniaturized instrumentation.

A 15-millimeter incision is made in the umbilicus, and a mul-

tichannel port is inserted to allow several devices to be used

simultaneously. Organs and tissues are removed through the

patient’s vagina.

“LESS surgery is fairly new, but we already see several poten-

tial advantages of single-port over conventional multiport

laparoscopy,” Dr. Escobar said. “We anticipate a possible

decrease in morbidity related to visceral and vascular

injury during trocar placement, as well as risk reduction of

postoperative wound infection, hernia formation and elimi-

nation of multiple trocar site closures.” Studies also suggest

improved postoperative pain profiles when compared to con-

ventional laparoscopic surgery. This may be due to the use

of the umbilicus as the single site of the incision, as it is one

of the thinnest regions on the abdominal wall, containing

few blood vessels, muscle or nerves.

Finally, LESS as well as other minimally invasive surgery

modalities contributes to patients’ postsurgical self-image

because of superior cosmesis from a relatively hidden

umbilical scar. “The Holy Grail of surgery is to leave little

or no scars. Technology is finally catching up with the goal,”

Dr. Escobar said.

LESS Oncologic Surgery

9clevelandclinic.org /obgyn | 800.553.5056

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Cleveland Clinic gynecologic oncologists understand the fear

and uncertainty a diagnosis of cancer can bring. Specialized

services and supportive care, such as access to support groups

and home care, arranged by clinical nurse specialists who also

provide counseling, are available to help patients through a

difficult time.

At Cleveland Clinic Taussig Cancer Institute, more than 250

cancer specialists, researchers, nurses and technicians are

dedicated to developing and applying the latest and most

effective medical techniques to achieve long-term survival and

improve the quality of life for more than 10,000 new cancer

patients every year. Because of the institute’s patient-centered

care, leading-edge treatments, innovative research, access

to clinical trials and state-of-the-art medical technologies,

U.S.News & World Report has ranked Cleveland Clinic’s cancer

program one of the top cancer centers in the nation. ◆

To contact Pedro Escobar, MD, please call 216.445.8486 or email [email protected]. To make a referral, please call 800.553.5057.

ViKY Robotic System

innovative Gynecologic Oncology Surgery continued

da Vinci Single-Site Platform

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Endometriosis Symptom Relief Methods Described in New Article

The clinical management of endometriosis is complex and somewhat controversial. Most gynecologists have patients

with recurring endometriosis-associated pain. The American College of Obstetricians and Gynecologists has released

an updated Practice Bulletin (Management of Endometriosis — Bulletin #114, published July 2010 in Obstetrics &

Gynecology) that deals with these issues.

Severe endometriosis involving the rectum, the ovary and the Fallopian tube.

A recent review article by Falcone and

Lebovic published in the Green jour-

nal this year (Falcone T, Lebovic DI.

Clinical management of endometriosis.

Obstet Gynecol. 2011 Sep;118(3):691-705)

expands on these ideas. The article

confirms the common notions that

diagnosis can be definitively made only

by laparoscopy, and that transvagi-

nal ultrasound remains the imaging

technique of choice for investigating

pain symptoms thought to stem from

endometriosis. Both fertility and pain

can be improved with surgery, but medi-

cal suppressive therapy will help relieve

pain but not improve fertility. If surgery

does not improve fertility, then assisted

reproductive technology is the next step.

Evidence is clear that postoperative

suppressive therapy with oral contracep-

tive can prevent the recurrence of pain

and ovarian cysts (endometriomas).

Surgical management of endometrio-

mas is particularly difficult because

resection may decrease ovarian reserve.

Techniques for achieving hemostasis

in these patients should minimize the

use of electrocautery.

Recurrence of pelvic pain is common

after medical and surgical treatment.

Hysterectomy with bilateral salpingo-

oophorectomy will help these patients,

but recent evidence shows that conserva-

tion of normal ovaries is an acceptable

option in these women. There is no

contraindication to the use of postop-

erative hormone replacement therapy

in young women who have undergone

definitive surgery. ◆

Tommaso Falcone, MD Chairman, Ob/Gyn & Women’s Health Institute

11clevelandclinic.org /obgyn | 800.553.5056

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Ethics and the Maternal-Fetal Dyad: Unique Challenges for Patient and Provider

The ethical challenges that arise in obstetrics are unique

because this field is so different from other areas of

medicine. Medical professionals are responsible for two

patients at the same time: the pregnant woman and the

developing fetus. “That’s what separates obstetrics from

other medical specialties; you have to consider the health

of the mother and the baby,” said Jeffrey Chapa, MD,

Head of Maternal-Fetal Medicine in Cleveland Clinic’s

Ob/Gyn & Women’s Health Institute. Dilemmas and

challenges can arise while trying to safeguard the

well-being of both.

In many instances, there is agreement between what a physi-

cian or midwife recommends for a pregnant woman and what

she feels is an appropriate healthcare plan. But difficulties

can arise when the choices of the pregnant woman do not

align with the recommendations of her healthcare provider

or, in the case of high-risk pregnancy, the multidisciplinary

healthcare team. “In such cases, ethics and ethics consulta-

tion play a key role in patient care,” said Ruth Farrell, MD, MA,

Assistant Professor of Surgery at the Cleveland Clinic Lerner

College of Medicine and a staff member in the Department of

Bioethics and the Ob/Gyn & Women’s Health Institute. “The

term ‘maternal-fetal conflict’ does not adequately describe

the unique interaction in the maternal-fetal dyad. This is an

ever-changing and unique state in which the well-being of the

mother and the fetus are intertwined. Conflict introduces the

notion that the interests of the mother and fetus are in direct

contest — something that is rarely the case.” Dr. Farrell said

that using the term “maternal-fetal dyad” instead more effec-

tively communicates the special state of pregnancy.

New advances in prenatal care can present unique challenges

for providers in balancing the health of the pregnant woman

and the fetus. Examples include procedures performed either

during pregnancy (such as maternal-fetal surgery) or at the

time of delivery. Such procedures, while intended to mitigate

the effect of a genetic condition or developmental abnormali-

ties on the fetus, do carry important risks for mother and fetus.

“Potential conflicts between the provider and the patient can

arise for any procedure, but particularly so when there is no or

scant evidence-based data to demonstrate positive outcomes

with the procedure,” said Dr. Farrell. Debate also can arise

when evidence demonstrates therapeutic promise for the

newborn but potentially serious medical complications for the

mother, as in the case of in-utero repair of neural tube defects.

As technology advances, it’s important for providers to con-

stantly reconsider the consideration of what data are available

about outcomes and how such procedures affect the health

of both mother and fetus.

One example is the EXIT (Ex-utero Intrapartum Treatment)

procedure — a surgical procedure performed on a newborn

while still attached to the umbilical cord to maintain utero-

placental gas exchange. The procedure was developed to

reverse tracheal occlusion in severe congenital diaphragmatic

hernia; it has been expanded to treat other indications such as

congenital high airway obstruction syndrome, large fetal neck

masses, and lung and mediastinal tumors.

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While the EXIT procedure can be lifesaving for the newborn,

it poses serious short-term and long-term risks for the mother.

Like fetal surgery, the EXIT Procedure has a direct impact on

a woman’s reproductive and overall health. “Any procedure

performed on the fetus is performed on the woman, so she

must be able to make an informed decision about whether

the procedure is right for her and her child,” said Dr. Farrell.

Whether a procedure is experimental or established,

informed decision making and communication with the

patient is critical. “You’ve got to spend time talking with the

patient, especially when explaining complicated procedures,”

said Dr. Chapa. “It’s important to give the patient detailed

information and allow her to choose.”

In addition, Dr. Farrell emphasized the importance of

informed decision-making. “It is not enough to give the

patient a laundry list of risks and expect her to make a

decision. The process of informed decisionmaking involves

having important data and also being able to align that

information with personal values and beliefs. As healthcare

providers, we must help our patients make informed

decisions that meet their needs because they are the

ones who must carry on after the delivery.”

Practitioners need to be vigilant in how they frame informa-

tion so they don’t bias the patient’s decision in a way that

does not meet her healthcare goals. “Many times, there may

be the hope of ‘doing something’ to try to improve the health

of the child. However, in these instances, there is the risk

that information could be framed in a way that places undue

burden on the pregnant women to go ahead with a procedure.

It is vital that healthcare providers present patients with the

scientific evidence, including risks and benefits, the knowns

and unknowns, in a meaningful way and support the woman

in making a decision that reflects her values and beliefs,”

said Dr. Farrell.

Sometimes, when a patient is uncertain about a recommended

procedure, Dr. Chapa may refer her for a second opinion.

“It may help the patient to hear another perspective,” he said.

When a patient’s choices appear to not be in agreement with

the clinical plan or recommendations, the provider may

uncover the reason by asking questions and getting to know

the patient better. “There may be something the patient

isn’t telling you. You don’t know all the circumstances,” said

Dr. Chapa. When he learned that one of his patients wasn’t

taking her medication because it was too expensive, Dr. Chapa

was able to switch her to a less expensive formulation.

Dr. Farrell advocates for giving patients the time and oppor-

tunity to gather information and make an informed decision.

“Timing is everything in pregnancy. Each gestational week

brings with it new challenges as the fetus comes closer to

viability and the mother’s body changes in ways that can make

her more susceptible to medical complications of pregnancy.

One of the challenges in obstetrics is that, in many cases, we

don’t have the luxury of time. While it is critical that patients

be prepared to make informed decisions, we have to recog-

nize that the clock does not stop ticking because we are in the

midst of an ethical or medical dilemma.” ◆

“One of the challenges in obstetrics is that,

in many cases, we don’t have the luxury

of time. While it is critical that patients be

prepared to make informed decisions, we

have to recognize that the clock does not

stop ticking because we are in the midst of

an ethical or medical dilemma.”

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Public reporting of hospital outcomes data has been making headlines recently as more and more facilities publish their

first editions. The Ob/Gyn & Women’s Health Institute is one of 16 institutes at Cleveland Clinic that has reported its

outcomes for physicians and patients since 2008 as part of the organization’s commitment to transparency.

The vast data collection involved in releasing outcomes

books every year allows the organization to uncover strengths

that are then cultivated, and also weaknesses that warrant

increased attention.

The extensive amount of data included in the Outcomes book

each year serves as an excellent resource for both care provid-

ers and patients. The institute applies what it learns from this

data to continue on the constant path of care improvement

and innovation.

The report provides data in a multitude of areas, from bone

density to hysterectomy rates to patient experience.

As procedures have become less invasive due to technological

advances in robotics and laparoscopic surgery, the duration

of patient stays has decreased. Patients can expect hospital

discharge in less than one week from their surgery — an

average decrease of about two days since last year.

Cleveland Clinic takes a minimally invasive approach to breast

cancer diagnosis. The majority of breast biopsies performed

were nonsurgical. Because of the advent of robotic-assisted

laparoscopy, minimally invasive procedures have increased

nearly fourfold since 2006 in gynecologic subspecialties, while

invasive procedures have stayed relatively stagnant. Following

the same general trend, the rate of surgical treatments for

women with endometriosis has decreased nearly 10 percent,

while medical treatments have risen in treating those patients.

When it comes to routine obstetric care, which is offered at

Cleveland Clinic community hospitals, improvements have

been made in vaginal deliveries. The use of episiotomy in

vaginal deliveries has decreased by more than 5 percent.

Additionally, the rate of successful Vaginal Birth After

Cesarean (VBAC) has significantly risen while that of failed

VBAC has dropped.

Reproductive endocrinology continues to see improvement.

While the success rates for in vitro fertilization (IVF) con-

tinue to improve over time, the patient’s age is the strongest

predictor of success. Cleveland Clinic’s In Vitro Fertilization

Laboratory employs cutting-edge technology to achieve fruit-

ful outcomes.

In urogynecology, strides have been made in reducing postsur-

gery small bowel obstruction. This past year, there were zero

incidences of small bowel obstruction following urogyneco-

logic surgery. While the surgical severity index has remained

constant, the 30-day readmission rate has been reduced by

nearly half. Patients’ length of stay in urogynecology has con-

tinued to be less than expected at all severity levels.

As part of the Surgical Care Improvement Program (SCIP),

Cleveland Clinic has tracked process measures showing

how consistently recommended care was provided to adult

patients. In all but one measure, Cleveland Clinic far sur-

passed the national benchmarks. “Patients First” is the

guiding principle of Cleveland Clinic, and the results of

patient surveys illustrate how well this mission is being

carried out. The overwhelming majority of outpatients of

the Ob/Gyn & Women’s Health Institute rated their care and

services and their outpatient provider as very good, and cited

the likelihood of recommending that care provider as very

good. Additionally, there have been improvements in the

Ob/Gyn & Women’s Health Institute’s HCAHPS assessment.

In the past year, significant increases have been reported

in patients’ overall ratings of the hospital and the percentage

of patients who would recommend the hospital to others.

Cleveland Clinic Outcomes Reporting Shows Promise and Progress

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Cleveland Clinic’s Ob/Gyn & Women’s Health Institute is

committed to providing world-class care to women of all

ages. The institute offers a full complement of subspecialty

services in the field of women’s health, from general obstet-

ric/gynecologic care and screenings for breast disorders

to complex oncologic surgery for breast and gynecologic

malignancies, management of fetal anomalies and cryo-

preservation of gametes.

In 2010, the Department of Obstetrics and Gynecology

was ranked No. 4 in the nation by U.S.News & World Report.

Cleveland Clinic offers 26 locations at which Obstetrics/

Gynecology, Breast Services and Women’s Health staff provide

comprehensive care. With more than 200,000 outpatient visits

in 2010, the Ob/Gyn & Women’s Health Institute strives to

continue this legacy with continuing innovation and trans-

parency of information, as demonstrated by the annual

report of clinical outcomes. ◆

To provide informational transparency, Cleveland Clinic Outcomes books are offered both in print and online. The Ob/Gyn & Women’s Health Institute Outcomes booklets are available at clevelandclinic.org/OutcomesOnline.

Clinical TrialsCleveland Clinic Ob/Gyn & Women’s Health Institute offers an online tool for physicians, patients and caregivers to search for open clinical trials. At any given time, there are hundreds of clinical trials under way at Cleveland Clinic.

To search for a clinical trial, go to clevelandclinic.org/obgynclinicaltrials.

Surgical Case Approach2006 – 2010

Pro

cedu

res

1,000

02006 2010

568 689N 6= 36 716 752

2007

600

800

200

400

2008 20092006 20102007 2008 2009

Laparoscopic/RoboticAbdominalVaginal

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REi Fellowship Program Offers Exposure to Medical and Surgical infertility Management

The Cleveland Clinic Reproductive Endocrinology and Infertility (REI) Fellowship is a relatively new program aimed at

preparing fellows for an academic career in reproductive endocrinology and infertility, according to Jeffrey Goldberg, MD,

who is the program director.

The program, which began in 2009, is

a three-year fellowship, approved by

the American Board of Obstetrics and

Gynecology (ABOG), leading to board

certification as a subspecialist in repro-

ductive endocrinology and infertility.

One new trainee is accepted each year

following completion of an ABOG-

approved Ob/Gyn residency.

Fellows gain clinical experience in

the full spectrum of reproductive

endocrinology and infertility. During

the first six months, the fellows rotate

in pediatric endocrinology, medical

endocrinology, medical genetics, male

infertility, pediatric/adolescent gyne-

cology, and menopausal medicine, in

addition to infertility and reproductive

surgery. The next year and a half are

protected to allow the fellow to focus

on research.

“We can offer the fellows tremendous

research opportunities,” Dr. Goldberg

said. “They have all the resources of

Cleveland Clinic available to them.

Depending on their particular area of

interest, they may conduct their work in

the IVF research laboratory, the Center

for Reproductive Medicine Research or

the Learner Research Institute.”

During the final year, the fellows are

involved in every aspect of the infertility

practice. Working with five board-certi-

fied reproductive endocrinologists, all

with different educational backgrounds,

the fellows gain a varied exposure to the

e d u C aT i o n

Left to right: Rebecca Flyckt, MD (second-year fellow); Jeffrey Goldberg, MD; Michelle Catenacci, MD (third-year fellow); Enrique Soto, MD (first-year fellow)

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Learn From Cleveland Clinic Top ExecutivesThe competencies needed to lead and manage differ from those needed

to be an effective administrator, clinician or scientist. Take advantage

of this opportunity to acquire skills and insights into the business of

healthcare excellence from top executives at Cleveland Clinic.

Two-day and two-week programs are open to healthcare executives

including physicians, nurses and administrators.

Visit clevelandclinic.org/ExecutiveEducation for details including the opportunity to earn 72.5 CME credits.

Gynecologic Oncology Fellowship Program Shapes Leaders

Cleveland Clinic’s Ob/Gyn & Women’s Health Institute is a proud

partner in a pathbreaking gynecologic oncology fellowship program.

Four or five fellows are enrolled in the three-year Cleveland Clinic

Gynecologic Oncology Fellowship program at any given time. There

are currently 16 alumni from this program dating back to 1996.

The program offers a wide range of superior training, education,

research and writing experiences.

Fellows receive broad training in management of gynecological cancers

via in-depth exposure to surgery, chemotherapy and palliative care. The

fellowship also has a robust program at the main campus, and Fairview

and Hillcrest Hospitals in minimally invasive surgery using robotics and

both standard and single-port laparoscopy.

For the past four years, fellows in this select program have had the distinct

opportunity to follow a track where they can explore a research thesis

based on clinical questions and have the additional option to obtain a

master’s in public health during their research year.

Selected residents from respected U.S. and international universities have

participated in the program. Applications are accepted each year and will be

accepted beginning March 2012 for the next class, which starts in July 2013.

A one-month Gruber Fellowship in Gynecologic Oncology is also offered

for third-year residents from other institutions who would like to gain

additional exposure to the field. ◆

For more information, contact Dr. Chad Michener at [email protected] or 216.445.0226.

medical and surgical management of

infertility patients.

The practice has a high-volume IVF

program with excellent success rates,

Dr. Goldberg said. Approximately 600

IVF cycles are performed each year,

encompassing every permutation includ-

ing ICSI, donor gametes, gestational

carriers, embryo co-culture, embryo

and oocyte cryopreservation, assisted

hatching, preimplantation genetic test-

ing, percutaneous sperm aspiration

and testicular sperm extraction.

A great strength of this program is

the very large volume and variety of

surgical cases. The fellows will develop

competency to independently perform

microsurgical reversal of sterilization

and surgical correction of congenital

malformations, myomas, tubal disease

and all stages of endometriosis utilizing

laparotomy, laparoscopy, hysteros-

copy and robotic surgery. In fact, Drs.

Falcone and Goldberg performed the

world’s first fully robotic surgery, a

tubal anastomosis, in 1998. The fellows

will also gain experience teaching resi-

dents in the clinic and operating room.

Highly regarded as a top hospital,

Cleveland Clinic was ranked No. 4 in the

nation in U.S. News & World Report’s Best

Hospitals 2011-2012. The Department of

Obstetrics and Gynecology at Cleveland

Clinic was also ranked No. 4 in the nation,

and is also noted as the top Ob/Gyn

department in Ohio. ◆

Fellows who are interested in taking advantage of this program are encour-aged to visit the Society for Reproductive Endocrinology and Infertility’s website at www.socrei.org where they can get more information and apply online.

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By Holly L. Thacker, MD, FACP, NCMP, CCD

Hormone therapy. Perimenopause. Menstrual disorders. Osteoporosis. Menopause. Incontinence. Breast concerns.

“Bioidentical hormone therapy.” Sexual problems. These are areas of special concern to women — not only because

they affect their physical health, but also because they impact their entire well-being.

Cleveland Clinic’s Center for Specialized Women’s Health,

located within the Ob/Gyn & Women’s Health Institute, offers

specialty care to meet women’s unique health care needs —

from routine health screenings to complex problems that

cross multiple disciplines.

Established in 2002 with a generous grant of $2 million

from the Avon Foundation, the Center for Specialized

Women’s Health offers comprehensive female-focused

care that includes the services of Cleveland Clinic’s Ob/Gyn,

Endocrinology, Internal Medicine and Breast Services, includ-

ing Imaging. The center also features the popular Shared

Medical Appointments, follow-up care in a shared setting

with other previously evaluated women who may share similar

health concerns and who want more time with their physician. 

The Center for Specialized Women’s Health houses one of the

oldest and most respected interdisciplinary women’s health

fellowships. Education of physicians including those in the

fields of medicine, Ob/Gyn, and Reproductive Endocrinology

and Infertility fellows learning about menopause, hormone

therapy, and osteoporosis are the core of the center’s educa-

tional mission.

Every day, the center has among its staff on-site women’s

health specialists, gynecologists, breast imaging radiologists,

nurse practitioners, bone density technicians and caring

nurses. Rotating into the center are physicians in different

disciplines from various women’s health specialty clinics

who provide additional services in our one-stop, female

focused environment. 

In fact, our center has distinguished itself as a practice

model such that we frequently host medical professionals

from around the globe who seek to replicate our model of

patient care in their home countries.

Center for Specialized Women’s Health:

A Special Answer to Women’s Unique Health Concerns

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Several Cleveland Clinic staff members also participate at the

leadership level in the North American Menopause Society

(NAMS). Many of our providers have been certified by NAMS

as Certified Menopause Practitioners, and the center has

the highest concentration of menopause-certified special-

ists in the world. This important certification demonstrates

that these practitioners have met national standards for

menopause practice, and exposes both our patients and our

trainees to leading-edge menopause-related healthcare at

midlife and beyond. The Center for Specialized Women’s

Health enjoys the distinction of having a staff that includes

the Executive Director of NAMS — Marjory Gass, MD — who 

is also the Deputy Editor of Menopause, which is one of the

most-cited women’s health journals.

We also offer women leading-edge and reliable tests to identify

and prevent potential health problems.  Bone mineral density

(BMD) tests, also known as dual energy X-ray absorptiometry

(DXA) scans, are offered to determine the bone density of the

spine, hip and wrist. We have suggested a national bench-

mark of 50 percent of women with abnormal DXAs returning

for repeat scan in two to three years.  On-site mammography,

pelvic ultrasound, office hysteroscopy, breast ultrasound and

thryoid ultrasound are also available, along with a breast-only

dedicated MRI. We are increasingly caring for women who

have identified genetic mutations that put them at higher risk

for female malignancies.

 When a woman is not sure what type of physician to see for a

particular women’s health concern, it can be difficult for even

the most savvy to determine what type of women’s health spe-

cialist to see. That’s why the Center for Specialized Women’s

Health has a strong commitment to lay outreach, education,

and physician and allied health collaboration. One of the

ways this commitment is put into practice is through the

Cleveland Clinic Women’s 4HER Health Line® at 216.444.4HER

(216.444.4437). Staffed Monday through Friday from 8 a.m.

to 4 p.m. ET, the 4HER line offers a nurse advocate who has

special training in women’s health issues.

The centerpiece of our outreach programs is the national

Speaking of Women’s Health program which includes a

vibrant website (www.speakingofwomenshealth.com) monthly

e-newsletter, tweets and blogs containing important health

messages, and national and regional uplifting health and well-

ness conferences exclusively for women. The Cleveland-area

Speaking of Women’s Health conference just celebrated its

10th anniversary in September and inducted 10 honorees into

the Speaking of Women’s Health Hall of Fame, which included

Tommaso Falcone, MD and Wulf Utian, MD, and our 4HER

nurse, Mary McDonnell, RN.

Cleveland Clinic’s Center for Specialized Women’s Health

has operated the national Speaking of Women’s Health

program since 2008. The Speaking of Women’s Health

motto is “Be Strong, Be Healthy, Be in Charge.” Speaking

of Women’s Health also includes the brands of Universal

Sisters, a program for women of color, and Hablando de

la Salud, a program for Latinas.

For more information about the services offered

by and the philosophy of Cleveland Clinic’s Center

for Specialized Women’s Health, visit our website

at clevelandclinic.org/WomensHealthServices. ◆

For additional information, contact Dr. Thacker at [email protected], or the Center for Specialized Women’s Health at 216.444.4437.

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Cleveland Clinic is pleased to announce the recent addition of three new breast surgeons to the staff of the

Ob/Gyn & Women’s Health Institute. The three doctors will practice at the main campus and at regional locations.

The Department of Breast Services will now be staffed by eight

highly skilled surgeons, the greatest number of dedicated

breast surgeons in the region.

The Ob/Gyn & Women’s Health Institute is committed to

providing world-class cancer care to women of all ages. The

institute offers a full complement of subspecialty services that

fall within the field of women’s health, from general gyne-

cologic care and screenings for breast disorders, to complex

oncologic surgery for breast and gynecologic malignancies.

Services are available on main campus, as well as in family

health centers and hospitals throughout the region.

The department’s staff includes breast surgeons, medical

breast specialists, midlevel providers and nurses. The staff

works closely with the Imaging Institute, which has 10 dedi-

cated breast imaging radiologists who perform and read our

screening and diagnostic mammograms and perform breast

ultrasounds, ultrasound-guided core biopsies, stereotactic

core biopsies and breast MRIs.

The department also collaborates with Medical and Radiation

Oncology and Plastic Surgery. About half of the department’s

mastectomy patients receive immediate breast reconstruction

performed as a combined procedure. Plastic surgery options

include the complex DIEP and Tram procedures.

Michael Cowher, MD, will practice at Cleveland Clinic’s main

campus and the Beachwood Family Health and Surgery

Center, Mita Patel, MD, will practice at Fairview Hospital, and

Stephanie Valente, DO, will see patients at the main campus

and the Strongsville Family Health and Surgery Center. ◆

To reach the Breast Center and the Center for Specialized Women’s Health appointment line, call 216.444.3024.

Left to right:

Stephanie Valente, DO Mita Patel, MD Michael Cowher, MD

Cleveland Clinic Ob/Gyn & Women’s Health Institute Announces

New Dedicated Breast Surgeons

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Coleman RL, Brady WE, McMeekin DS, Rose PG, Soper JT, Lentz SS, Hoffman JS, Shahin MS. A phase II evaluation of nanoparticle, albumin-bound (nab) paclitaxel in the treatment of recurrent or persis-tent platinum-resistant ovarian, fallopian tube, or primary peritoneal cancer: a Gynecologic Oncology Group study. Gynecol Oncol. 2011 Jul;122(1):111-115.

Davila GW. Nonsurgical outpatient therapies for the management of female stress urinary incontinence: long-term effectiveness and durabil-ity. Adv Urol. 2011;2011:176498.

Desai N, Xu J, Tsulaia T, Szeptycki-Lawson J, Abdelhafez F, Goldfarb J, Falcone T. Vitrification of mouse embryo-derived ICM cells: a tool for preserving embryonic stem cell potential? J Assist Reprod Genet. 2011 Feb;28(2):93-99.

Diwadkar GB, Falcone T. Surgical management of pain and infertility secondary to endometriosis. Semin Reprod Med. 2011;29(2):124-9.

El-Halawaty S, Azab H, Said T, Bedaiwy M, Amer M, Kamal M, Al-Inany H. Assessment of male serum anti-Mullerian hormone as a marker of spermatogenesis and ICSI outcome. Gynecol Endocrinol. 2011 Jun;27(6):401-405.

Escobar PF. Haber GP. Kaouk J. Kroh M. Chalikonda S. Falcone T. Single-port surgery: laboratory experience with the davinci single-site platform. J Soc Laparoendosc Surg. 2011;15(2):136-41.

Esteves SC, Agarwal A. Novel concepts in male infertility. Int Braz J Urol. 2011 Jan;37(1):5-15.

Esteves SC, Miyaoka R, Agarwal A. An update on the clinical assess-ment of the infertile male. Clinics (Sao Paulo). 2011;66(4):691-700.

Falcone T. Robotics in gynecological surgery: the story so far and a glimpse into the future. Expert Rev Obstet Gynecol. 2011 Jul;6(4):361-363.

Falcone T. Lebovic DI. Clinical management of endometriosis. Obstet Gyncol. 2011; 118(3):691-705.

Farley J, Sill MW, Birrer M, Walker J, Schilder RJ, Thigpen JT, Coleman RL, Miller BE, Rose PG, Lankes HA. Phase II study of cisplatin plus cetuximab in advanced, recurrent, and previously treated cancers of the cervix and evaluation of epidermal growth factor receptor immunohis-tochemical expression: A Gynecologic Oncology Group study. Gynecol Oncol. 2011 May 1;121(2):303-308.

Farrell RM. Divide and conquer: teasing out the cause of heart defects in Down syndrome. Sci Transl Med. 2011;3(79):79ec54.

Farrell RM, Dolgin N, Flocke SA, Winbush v, Mercer MB, Simon C. Risk and uncertainty: Shifting decision making for aneuploidy screening to the first trimester of pregnancy. Genet Med. 2011 May;13(5):429-436.

Flyckt R, Lyden S, Roma A, Falcone T. Post-menopausal endometriosis with inferior vena cava invasion requiring surgical management. Hum Reprod. 2011; 26(10):2709-12.

Journal Publications

Abdelhafez F, Xu J, Goldberg J, Desai N. Vitrification in open and closed carriers at different cell stages: assessment of embryo survival, development, DNA integrity and stability during vapor phase storage for transport. BMC Biotechnol. 2011;11:29.

Agarwal A, Sekhon LH. Oxidative stress and antioxidants for idio-pathic oligoasthenoteratospermia: is it justified? Indian J Urol. 2011 Jan;27(1):74-85.

Aghajanian C, Sill MW, Darcy KM, Greer B, McMeekin DS, Rose PG, Rotmensch J, Barnes MN, Hanjani P, Leslie KK. Phase II trial of beva-cizumab in recurrent or persistent endometrial cancer: a Gynecologic Oncology Group study. J Clin Oncol. 2011 Jun 1;29(16):2259-2265.

Aziz N, Sharma RK, Mahfouz R, Jha R, Agarwal A. Association of sperm morphology and the sperm deformity index (SDI) with poly (ADP-ribose) polymerase (PARP) cleavage inhibition. Fertil Steril. 2011 Jun 30;95(8):2481-2484.

Barakat EE. Bedaiwy MA. Zimberg S. Nutter B. Nosseir M. Falcone T. Robotic-assisted, laparoscopic, and abdominal myomectomy: a com-parison of surgical outcomes. Obstet Gyncol. 2011; 117(2 Pt 1):256-65.

Barber MD. Incontinence: should mesh be used to correct anterior vagi-nal prolapse?. Nature Rev Urol. 2011; 8(9):476-8.

Barber MD, Chen Z, Lukacz E, Markland A, Wai C, Brubaker L, Nygaard I, Weidner A, Janz NK, Spino C. Further validation of the short form versions of the Pelvic Floor Distress Inventory (PFDI) and Pelvic Floor Impact Questionnaire (PFIQ). Neurourol Urodyn. 2011 30(4):541-6.

Bedaiwy MA, Barakat EM, Falcone T. Robotic tubal anastomosis: techni-cal aspects. J Soc Laparoendosc Surg. 2011; 15(1):10-5.

Belinson JL, Wu R, Belinson SE, Qu X, yang B, Du H, Wu R, Wang C, Zhang L, Zhou y, Liu y, Pretorius RG. A population-based clinical trial comparing endocervical high-risk HPv testing using Hybrid Capture 2 and Cervista from the SHENCCAST II study. Am J Clin Pathol. 2011 May;135(5):790-795.

Bradley LD. Diagnosis of abnormal uterine bleeding with biopsy or hys-teroscopy. Menopause. 2011 Apr;18(4):428-439.

Catenacci M. Flyckt RL. Falcone T. Robotics in reproductive surgery: strengths and limitations. Placenta. 2011; 32 Suppl 3:S232-7.

Carvalho L, Podgaec S, Bellodi-Privato M, Falcone T, Abrao MS. Role of eutopic endometrium in pelvic endometriosis. J Minim Invasive Gynecol. 2011 Jul-Aug;18(4):419-427.

Cheng v, Doshi KB, Falcone T, Faiman C. Hyperandrogenism in a postmenopausal woman: diagnostic and therapeutic challenges. Endocr Pract. 2011 Mar-Apr;17(2):e21-e25.

Selected Publications From Cleveland Clinic’s Ob/Gyn & Women’s Health institute

Left to right:

Stephanie Valentine, MD Mita Patel, MD Michael Cowher, MD

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Rose PG, Brady MF. EORTC 55971: Does it apply to all patients with advanced state ovarian cancer? Gynecol Oncol. 2011 Feb;120(2):300-301.

Sabanegh E, Agarwal A, Sharma R, French D, Deepinder F, Hamada A. The natural history of seminal leukocytes in men seeking infertility evalu-ation. J Clin Embryol. 2011 Summer;14(2):25-29.

Skaznik-Wikiel ME, Ueda SM, Frasure HE, Rose PG, Fleury A, Grumbine FC, Fader AN. Abnormal cervical cytology in the diagnosis of uterine papillary serous carcinoma: earlier detection of a poor prognostic cancer subtype? Acta Cytol. 2011;55(3):255-260.

Svets M, Falcone T. Update on gynecologic surgery. The 13th annual Pelvic Anatomy and Gynecologic Surgery Symposium. Womens Health. 2011; 7(2):159-61.

Thacker HL. Assessing risks and benefits of nonhormonal treatments for vasomotor symptoms in perimenopausal and postmenopausal women. J Womens Health (Larchmt ). 2011 Jul;20(7):1007-1016.

Thacker S, yadav SP, Sharma RK, Kashou A, Willard B, Zhang D, Agarwal A. Evaluation of sperm proteins in infertile men: a proteomic approach. Fertil Steril. 2011 Jun 30;95(8):2745-2748.

Weinberg LE, Lurain JR, Singh DK, Schink JC. Survival and reproduc-tive outcomes in women treated for malignant ovarian germ cell tumors. Gynecol Oncol. 2011 May 1;121(2):285-289.

yoon Dy, Dole A, Gonsalves L. Takotsubo (stress-induced) car-diomyopathy in post-menopausal women. Psychosomatics. 2011 Jul-Aug;52(4):375-378.

Book Chapters

Catenacci M, Bedient C, Falcone T. Use of robotics in reproductive surgery. In: Gardner DK, Rizk BRMB, Falcone T, eds. Human Assisted Reproductive Technology : Future Trends in Laboratory and Clinical Practice. Cambridge: Cambridge University Press; 2011: 1-10.

Esteves SC, Agarwal A. Sperm retrieval techniques. In: Gardner DK, Rizk BRMB, Falcone T, eds. Human Assisted Reproductive Technology: Future Trends in Laboratory and Clinical Practice. Cambridge: Cambridge University Press; 2011: 41-53.

Schultz BAH, Falcone T. The role of definitive surgery in the manage-ment of CPP and posthysterectomy pain. In: vercellini P, ed. Chronic Pelvic Pain. Chichester, West Sussex; Hoboken, NJ: Wiley-Blackwell; 2011: 155-166.

Book, Whole

Gardner DK, Rizk BRMB, Falcone T. Human Assisted Reproductive Technology : Future Trends in Laboratory and Clinical Practice. Cambridge Cambridge University Press; 2011.

Frick AC, Barakat EE, Stein RJ, Mora M. Falcone T. Robotic- assisted laparoscopic management of ureteral endometriosis. J Soc Laparoendosc Surg. 2011:15(3):396-9.

Frumovitz M, Escobar P, Ramirez PT. Minimally invasive surgical approaches for patients with endometrial cancer. Clin Obstet Gynecol. 2011 Jun;54(2):226-234.

Gravitt PE, Belinson JL, Salmeron J, Shah Kv. Looking ahead: a case for human papillomavirus testing of self-sampled vaginal speci-mens as a cervical cancer screening strategy. Int J Cancer. 2011 Aug 1;129(3):517-527.

Gupta S, Choi A, yu Hy, Czerniak SM, Holick EA, Paolella LJ, Agarwal A, Combelles CM. Fluctuations in total antioxidant capacity, catalase activity and hydrogen peroxide levels of follicular fluid during bovine fol-liculogenesis. Reprod Fertil Dev. 2011 Jun;23(5):673-680.

Muffly TM, Kow N, Iqbal I, Barber MD. Minimum number of throws needed for knot security. J Surg Educ. 2011; 68(2):130-3.

Muffly TM, Tizzano AP. Walters MD. The history and evolution of sutures in pelvic surgery. J Royal Soc Med. 2011; 104(3):107-12.

Mullany SA, Moslemi-Kebria M, Rattan R, Khurana A, Clayton A, Ota T, Mariani A, Podratz KC, Chien J, Shridhar v. Expression and functional significance of HtrA1 loss in endometrial cancer. Clin Cancer Res. 2011 Feb 1;17(3):427-436.

Paraiso MF, Jelovsek JE, Frick A, Chen CC, Barber MD. Laparoscopic compared with robotic sacrocolpopexy for vaginal prolapse: a random-ized controlled trial. Obstet Gyncol, 2011; 118(5):1005-13.

Posillico S, Kader A, Falcone T, Agarwal A. Ovarian tissue vitrification: modalities, challenges and potentials. Curr Womens Health Rev. 2010 Nov;6(4):352-366.

Pretorius RG, Belinson JL, Burchette RJ, Hu S, Zhang X, Qiao yL. Regardless of skill, performing more biopsies increases the sensitivity of colposcopy. J Low Genit Tract Dis. 2011 Jul;15(3):180-188.

Reddy J, Barber MD, Walters MD, Paraiso MFR, Jelovsek JE. Lower abdominal and pelvic pain with advanced pelvic organ prolapse: a case-control study. Am J Obstet Gynecol. 2011 Jun;204(6):537.e1-537.e5.

Rein BJD, Gupta S, Dada R, Safi J, Michener C, Agarwal A. Potential markers for detection and monitoring of ovarian cancer. J Oncol. 2011;2011:475983.

Ridgeway B, Arias BE, Barber MD. The relationship between anthro-pometric measurements and the bony pelvis in African American and European American women. Int Urogynecol J. 2011; 22(8):1019-24.

Rose PG. Combination therapy: New treatment paradigm for locally advanced cervical cancer? Nat Rev Clin Oncol. 2011;8(7):388-390.

Rose PG, Ali S, Whitney CW, Lanciano R, Stehman FB. Outcome of stage IvA cervical cancer patients with disease limited to the pelvis in the era of chemoradiation: A Gynecologic Oncology Group study. Gynecol Oncol. 2011 Jun 1;121(3):542-545.

Selected Publications continued

22 CLEvELAND CLINIC OB/GyN & WOMEN’S HEALTH PERSPECTIvES | WINTER 2011

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Cleveland Clinic Ob/Gyn Doctors

Lead National Groups

Linda Bradley, MD recently

completed her first term as

President of the American

Association of Gynecological

Laparoscopists

Matthew Barber, MD

President of the American

Urogynecologic Society

Jeffrey Goldberg, MD

President of the

Society for Assisted

Reproductive Technology

Mark Walters, MD

President-Elect of the Society

of Gynecologic Surgeons

(President in April 2012)

77780_CCFBCH_Brochure_ACG.indd 24 11/21/11 10:44 AM