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Dr. Parker's Fibroids Blog

Myths You May be Told as to Why You Need a Hysterectomy Instead of a Myomectomy

Dr. Parker has just written an article for OBG Management, a free OB-Gyn journal with the largest number of readers of all the OB-Gyn journals.  In this article, Dr. Parker debunks the myths that gynecologists have been taught about myomectomy and the myths that women are often told as the reasons why they should have a hysterectomy.  OBG Management has given us permission to link to the complete article:

7 Myomectomy myths debunked

OBG Manag. 2017 February;29(2):42-48

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Reply to FDA regarding the use of power morcellators for fibroids

Jeffrey Shuren, M.D., J.D., the Director of the Center for Device and Radiological Health at the Food and Drug Administration, replied to an open letter from the Leiomyoma Morcellation Review Group.  You can read the original open letter here, and view Dr. Shuren’s reply in the images below.

from FDA 1from FDA 2

The Leiomyoma Morcellation Review Group sent the following letter to the FDA in response:

Dear Dr. Shuren,

Thank you for your response to our letter and for your invitation to continue the dialog regarding the FDA’s restriction on the use of the morcellator for the majority of women with uterine fibroids.  We respect the FDA’s difficult position in this matter, especially considering the adverse publicity and pressure  generated by Dr. Reed’s husband. As responsible physicians and women’s health-care advocates we think that women who need treatment for uterine fibroids, as with all patients, deserve to make treatment decisions based on the best information available.  We know that this is also something that the FDA believes as well.  We would like to make the following comments:

1) As we are sure you are aware, a recent publication from the Michigan Surgical Quality Collaboration showed that the rate of laparoscopic hysterectomies decreased and the rate of abdominal hysterectomies increased following the FDA’s restrictive policy on morcellation, and there was an associated concomitant increase in major surgical complications and 30-day readmissions to the hospital (Harris).  This increase in morbidity was anticipated by the decision analysis published by Siedhoff and colleagues.  Unintentionally, the FDA is compromising the health of some women.  Our concerns regarding higher surgical morbidity associated with increased use of laparotomy for women needing surgical treatment for fibroids drove our decision to prepare our letter questioning the FDA’s guidance regarding morcellation.  Unfortunately, our concerns are now validated by published data.

2) In our letter to the FDA and our commentary published in Obstetrics and Gynecology, we did “challenge” your methodology and calculation of the prevalence of leiomyosarcoma among women having surgery for presumed fibroids, as well as the impact of electro-mechanical morcellation on survival.  We are very concerned that your researcher did not carefully consider all of the published data available at that time.  We are also concerned that the FDA analysis was reported to be performed by a close friend of Dr. Noorchashm and that this conflict of interest was not disclosed during the hearing.

The Kaiser study that you cite is only one of many recent attempts to determine the prevalence of LMS among women having surgery for uterine fibroids.  In a further analysis, we added the women from the Bojahr study cited by us and the Raines-Bennet study cited by you and re-calculated our meta-analysis.  The rate of LMS then becomes 1:1924 or 0.052% and essentially no different from our original calculation.

3) In the Kaiser study you cite, our concern is that it appears that you incorrectly state that “the adjusted risk ratio for death at one year for power morcellated uteri was significantly greater compared to uteri that were not morcellated”.  In fact, there was no difference in one year survival in these groups of women, as noted in the abstract and indicated in Figure 3.    The only statistically significant finding in that analysis was the one-year comparison of women with any type of morcellation compared with no morcellation, suggesting that power morcellation is not the determining factor.  The analysis also showed no increased mortality at  2 or 3 years, consistent with an aggressive disease that has early spread by the hematogenous route.

Additionally, the FDA did not carefully considered the published literature. Indeed, the data used to determine that laparoscopic power morcellation “significantly worsening the patient’s long-term survival” has been criticized by us and others for being of poor quality characterized by heterogeneous referral populations, small numbers and suboptimal quantitative analysis.

Furthermore, since the vast majority of cases analyzed in the literature were morcellation procedures performed using a scalpel via either the vaginal or mini-laparotomy routes, it would seem reasonable to restrict of vaginal and mini-lap morcellation in addition to electro-mechanical morcellation.  Such a restriction would essentially limit surgical options for women with fibroids to total abdominal hysterectomy, a position that would be called into question by most women and their gynecologists.

We respect the concerns of the FDA staff.  However, the FDA’s  decision  to place a boxed warning, albeit intended to protect women and to make them aware of risks,  has in fact reduced treatment options for women, paradoxically increasing the risks associated with surgery for uterine fibroids. Although we are not questioning your intentions, your agency’s actions do not appear consistent with your mission to ensure the safety and health of all women.

4) While we agree that a registry might clarify the prevalence of LMS and the influence of morcellation on survival, the registry would need to be mandatory for all US women with uterine LMS.  With such a rare condition, anything less would be subject to significant selection and reporting bias.   We are aware that a registry of women with leiomyomas is currently being developed through funding from PCORI and that this will provide important prospective data.  It will be essential to have appropriate funding for an LMS registry as well.  We sincerely hope that the FDA is discussing this need with your sister federal agencies.

Women and their physicians look to the FDA for guidance on issues that impact public health and safety. We do not feel that women have been properly served by the FDA’s current morcellation advisory.  We request that the FDA reconsider the currently available data and re-evaluate the restrictions on the use of the electro-mechanical morcellator for the majority of women with uterine fibroids.  We welcome the opportunity to talk to you about these issues and would be willing to send a group to Washington for further discussion if you wish.  We are confident that the FDA shares with our group a common concern for the health and safety of all women with leiomyomas. Our goal is to find a way forward that will provide an appropriate and reasonable approach to uterine leiomyoma treatment and medical care.

Thank you for your consideration,

William H. Parker, MD, Santa Monica-UCLA Medical Center

Andrew M. Kaunitz, MD , University of Florida College of Medicine–Jacksonville

Elizabeth Pritts, MD, Middleton, WI

David Olive, MD, Middleton, WI

Eva Chalas, MD, FACOG, FACS, Winthrop-University Hospital, Mineola, NY

Daniel L. Clarke-Pearson, MD, UNC-Chapel Hill

Jonathan S Berek, MD, MMS, Stanford University School of Medicine

Barbara Goff, MD, University of Washington, Seattle, WA

Robert Bristow, MD, UC Irvine School of Medicine

Robin Farias-Eisner, MD, David Geffen School of Medicine at UCLA

Amanda Nickles Fader, MD, Johns Hopkins Medicine

G Larry Maxwell, MD, FACOG, COL(ret) U.S. Army, Inova Fairfax Hospital

Scott C Goodwin, MD, University of California, Irvine

Susan Love, MD, Dr. Susan Love Research Foundation, Los Angeles, California

William E Gibbons, MD, Baylor College of Medicine

Leland J. Foshag, M.D., FACS, John Wayne Cancer Institute, Santa Monica, California

Phyllis C. Leppert, MD, PhD, Duke University School of Medicine

Charles W. Nager, MD, UC San Diego Health System

Judy Norsigian, Our Bodies, Ourselves, Boston, Mass

Timothy Johnson, MD, University of Michigan

David S. Guzick, MD, PhD, University of Florida

Anton J. Bilchik, MD, PhD, FACS, John Wayne Cancer Institute, Santa Monica, California

Hugh Taylor, MD, Yale School of Medicine

Richard J. Paulson, MD, Keck School of Medicine, University of Southern California

Professor Cindy Farquhar, University of Auckland, NZ

Sawsan As-Sanie, MD MPH, University of Michigan

Linda D. Bradley, MD, Cleveland Clinic

Stacey A. Scheib, MD, Johns Hopkins Hospital

Carla Dionne, MPH, MBA, National Uterine Fibroid Foundation

Laurel W. Rice, MD , University of Wisconsin-Madison School of Medicine and Public Health

Alison Jacoby, MD, University of California, San Francisco

Charles Ascher-Walsh, MD, Mt. Sinai School of Medicine

G. David Adamson, MD, Stanford University School of Medicine

Matthew Siedhoff, MD MSCR, University of North Carolina at Chapel Hill

Robert Israel, M.D, Keck School of Medicine, University of Southern California

Marie Fidela Paraiso, MD, Cleveland Clinic

Michael M. Frumovitz, M. D., M.P.H., FACOG, FACS, The University of Texas MD Anderson Cancer Center

Guy I. Benrubi, M.D., University of Florida College of Medicine – Jacksonville

Steven S. Raman, MD, David Geffen School of Medicine at UCLA

Rosanne M Kho MD, Columbia University Medical Center

John R Lurain, MD, Northwestern University Feinberg School of Medicine

Ayman Al-Hendy  MD PhD FRCSC FACOG CCRP, Medical College of Georgia

Ted L. Anderson, M.D., Ph.D., Vanderbilt University School of Medicine

R. Kevin Reynolds, MD, FACS, FACOG, University of Michigan

John DeLancey, MD, University of Michigan Health System

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An open letter to the FDA regarding the use of morcellation procedures for women having surgery for presumed uterine fibroids

In November, 2014 the FDA ruled that power morcellation was contra-indicated in “the majority of women” having surgery for uterine fibroids due to the potential risk of spreading occult uterine sarcoma.  Although problems with this ruling were immediately apparent, the passage of time has allowed for more clarity on the related medical issues.

Prevalence of Leiomyosarcoma among women having surgery for presumed uterine fibroids

The prevalence of occult leiomyosarcoma among women with fibroids is critical for every patient.  All medical procedures have potential risk and the patient’s understanding of risk is the foundation of medical decision-making.

The FDA estimated that for every 458 women having surgery for fibroids, one woman would be found to have an occult leiomyosarcoma (LMS).  We challenge this calculation.  To estimate this risk, the FDA searched medical databases using the terms “uterine cancer” AND “hysterectomy or myomectomy”.   Because “uterine cancer” was required, studies where cancer was not found or discussed were not identified.  Nine studies, all but one of which were retrospective, were analyzed including a non-peer-reviewed letter to the editor and an abstract from an unpublished study. (Leung, Rowland)    Additionally,  three “leiomyosarcoma ” cases identified by the FDA do not meet current pathologic criteria for cancer and would now be classified as benign “atypical” leiomyomas.  If atypical leiomyomas and non-peer-reviewed data are excluded, the FDA identified 8 cases of LMS among 12,402 women having surgery for presumed leiomyomas, a prevalence of 1 in 1,550 (0.064%).

Pritts et al. recently published a more rigorous meta-analysis of 133 studies and determined that the prevalence of LMS among women having surgery for presumed fibroids was 1 in 1,960, or 0.051%.   All peer-reviewed reports in which surgery was performed for presumed fibroids were analyzed, including reports where cancer was not found. Inclusion criteria required that histopathology results be explicitly provided and available for interpretation. Among the 26 randomized control trials analyzed, 1,582 women had surgery for fibroids and none were found to have LMS.   Bojahr et al., recently published a large population-based prospective registry study and reported 2 occult LMS among 8,720 women having surgery for fibroids (0.023%).    In summary, the re-analyzed FDA dataset yields a prevalence of 1 in 1,550 (0.064%), the Pritts study reports a prevalence of 1 in 1,960 (0.051%) with the RCT’s having a prevalence of 0 and the Bojahr study reported a prevalence of 2 of 8,720 (0.023%). We acknowledge that with rare events statistical analysis may be uncertain and confidence Intervals may be wide.  However, these numbers do not support the FDA’s estimated prevalence of LMS among women having surgery for presumed fibroids and those at risk for morcellation of a leiomyosarcoma.

Prognosis for women with morcellated LMS

Leiomyosarcoma, removed intact without morcellation have a poor prognosis.  Based on SEER data, the 5 year survival of Stage I and II LMS is only 61%. (Kosary)   Whether morcellation influences the prognosis of women with LMS is not known and the biology of this tumor has not been well studied.  Distant metastasis occur early in the disease process, primarily hematogenous dissemination.  Four frequently quoted published studies examine survival following power-morcellation.  Surprisingly, virtually none of the women in these studies had power-morcellation.  Furthermore, the data presented in these reports are poorly analyzed and patient numbers are very small.  Park, et. al. reported only one of the 25 morcellated cases had laparoscopic surgery with power-morcellation.   Eighteen women had a laparoscopically-assisted vaginal hysterectomy with scalpel-morcellation performed through the vagina, one had a vaginal hysterectomy with scalpel-morcellation and 5 had mini-laparotomy with scalpel-morcellation through small lower abdominal incisions.  Seventeen of the 25 patients plotted in the published survival curve were referred to the hospital after initial diagnosis or the discovery of a recurrence at another institution. Since the number of non-referred women with less aggressive disease or without recurrence is not known, it is not possible to determine differences in survival between patients with and without morcellation.    In a study by Perri et. al., none of the patients had power-morcellation.   Four women had an abdominal myomectomy, four had a hysteroscopic myomectomy with tissue confined within the uterine cavity, two had a laparoscopic hysterectomy with scalpel-morcellation, four had a supra-cervical abdominal hysterectomy with cut-through at the cervix and two had an abdominal hysterectomy with injury to the uterus with a sharp instrument.   When comparing the outcomes for women with morcellated and non-morcellated LMS, Morice et. al., found no difference in recurrence rates or over-all and disease-free survival at six months.  In the only study to compare use of power- with scalpel-morcellation in women with LMS, Oduyebo et. al. found no difference in outcomes for the 10 women with power-morcellation and five with scalpel-morcellation followed for a median of 27 months (range, 2-93).    Notably, a life table analysis of the above studies showed no difference in survival between morcellation methods. (Pritts)

Of note, laparoscopic-aided morcellation allows the surgeon to inspect the pelvic and abdominal cavities and irrigate and remove tissue fragments under visual control. In contrast, the surgeon cannot visually inspect the peritoneal cavity during vaginal or mini-laparotomy procedures.  Morcellation within containment bags have recently been utilized in an attempt to avoid spread of tissue.  These methods have not yet been proven effective or safe, and there is  concern that bags may make morcellation more cumbersome and less safe.

What the FDA Restrictions Mean for Women

The FDA communication states, “the FDA is warning against the use of laparoscopic -morcellators in the majority of women undergoing myomectomy or hysterectomy for treatment of fibroids.”  This statement is not consistent with current evidence.  Moreover, a severe restriction of morcellation, including vaginal and mini-laparotomy morcellation, would limit women with symptomatic leiomyomas to one option, total abdominal hysterectomy. For women with fibroids larger than a 10-week pregnancy size, which most often require either scalpel or power-morcellation in order to remove tissue, a ban on morcellation would eliminate the following procedures:

  • vaginal hysterectomy (scalpel morcellation)
  • mini-laparotomy hysterectomy (scalpel morcellation)
  • laparoscopic hysterectomy (scalpel morcellation)
  • laparoscopic supra-cervical hysterectomy (cervix cut-through)
  • open supra-cervical hysterectomy (cervix cut-through)
  • laparoscopic myomectomy (power morcellation)
  • mini-laparotomy myomectomy (scalpel morcellation)
  • hysteroscopic myomectomy (intrauterine morcellation)
  • uterine artery embolization (no specimen and will delay diagnosis)
  • high-intensity focused ultrasound (no specimen and will delay diagnosis)

If abdominal hysterectomy is recommended to women with fibroids, will women be better off?

By focusing exclusively on the risk of LMS, the FDA failed to take into account other risks associated with surgery.   Laparoscopic surgery uses small incisions, is performed as an out-patient procedure (or overnight stay), has a faster recovery (2 weeks versus 4-6 for open surgery) and is associated with lower mortality and fewer complications.  These benefits of minimally invasive surgery are now well-established in gynecologic and general surgery.  Using published best-evidence data, a recent decision analysis showed that, comparing 100,000 women having laparoscopic hysterectomy with 100,000 having open hysterectomy, the group having laparoscopic surgery  would experience 20 fewer peri-operative deaths, 150 fewer women would have a pulmonary or venous embolus and 4,800 fewer women would have a wound infection. (Seidhoff)   Importantly, women having open surgery would have 8,000 fewer quality-of-life years.  A recently published study found that  in the eight months following the FDA safety communication, utilization of laparoscopic hysterectomies decreased by 4.1% (p=0.005) and both abdominal and vaginal hysterectomies increased (1.7%, p =0.112 and 2.4%, p=0.012, respectively). (Harris)  Major surgical complications (not including blood transfusions) significantly increased from 2.2% to 2.8% (p=0.015), and the rate of hospital readmission within 30 days also increased from 3.4% to 4.2% (p=0.025).  These observations merit consideration as women weigh the pros and cons of minimally-invasive surgery with morcellation versus open surgery.  These observations merit consideration as women weigh the pros and cons of minimally invasive surgery with possible morcellation vs. open surgery.

Clinical Recommendations

Recent attention to surgical options for women with uterine leiomyomas and the risk of an occult leiomyosarcoma is a positive development in that the gynecologic community is re-examining relevant issues. We respectfully suggest that the following clinical recommendations be considered:

  • The risk of LMS is higher in older post-menopausal women and greater caution should be exercised prior to recommending morcellation procedures for these women.
  • Preoperative consideration of LMS is important and women age 35 or older with irregular uterine bleeding and presumed fibroids should have an endometrial biopsy, which occasionally may detect LMS prior to surgery.  Women should have  normal results of cervical cancer screening.
  • Ultrasound or MRI findings of a large irregular vascular mass, often with irregular anechoic (cystic) areas reflecting necrosis, may cause suspicion of LMS.
  • Women wishing minimally-invasive procedures with morcellation, including scalpel-morcellation via the vagina or mini-laparotomy, or power-morcellation using laparoscopic guidance, should understand the potential risk of decreased survival should LMS be present.  Open procedures should be offered to all women who are considering minimally -invasive procedures for “fibroids”.
  • Following morcellation, careful inspection for tissue fragments should be undertaken and copious irrigation of the pelvic and abdominal cavities should be performed to minimize the risk of retained tissue.
  • Further investigations of a means to identify LMS pre-operatively should be supported.  Likewise, investigation into the biology of LMS should be funded to better understand the propensity of tissue fragments or cells to implant and grow.    With that knowledge, minimally- invasive procedures could be avoided for women with LMS and women choosing minimally-invasive surgery could be re-assured that they do not have LMS.

Respecting women who suffer from leiomyosarcoma, we conclude that the FDA directive was based on a misleading analysis.   Consequently, more accurate estimates regarding the prevalence of LMS among women having surgery for fibroids should be issued. Women have a right to self-determination.   Modification of the FDA’s current restrictive guidance regarding power-morcellation would empower each woman to consider the pertinent issues and have the freedom to undertake shared decision-making with her surgeon in order to select the procedure which is most appropriate for her.

William Parker, MD
Clinical Professor
UCLA School of Medicine
Director, Minimally Invasive Gynecologic Surgery
Santa Monica-UCLA Medical Center

Jonathan S Berek, MD, MMS
Laurie Kraus Lacob Professor
Director, Stanford Women’s Cancer Center
Director, Stanford Health Care Communication Program
Chair, Department of Obstetrics and Gynecology
Stanford University School of Medicine

Elizabeth Pritts, MD
Wisconsin Fertility Institute
Middleton, WI

David Olive, MD
Wisconsin Fertility Institute
Middleton, WI

Andrew M. Kaunitz, MD
University of Florida Research Foundation Professor
Associate Chair, Department of Obstetrics and Gynecology
University of Florida College of Medicine–Jacksonville

Eva Chalas, MD, FACOG, FACS
Chief, Division of Gynecologic Oncology
Director of Clinical Cancer Services
Vice-Chair, Department of Obstetrics and Gynecology
Winthrop-University Hospital

Daniel Clarke-Pearson, MD
Professor and Chair
Clinical Research, Gynecologic Oncology Program
UNC-Chapel Hill

Barbara Goff, MD
Professor of Obstetrics and Gynecology
Director, Division of Gynecologic Oncology
University of Washington
Seattle, WA

Robert Bristow, MD
Professor and Chair
Department of Obstetrics and Gynecology
UC Irvine School of Medicine

Hugh S. Taylor, M.D.
Anita O’Keeffe Young Professor and Chair Department of Obstetrics, Gynecology and Reproductive Sciences, Yale School of Medicine
Chief of Obstetrics and Gynecology
Yale-New Haven Hospital

Robin Farias-Eisner, MD
Chief of Gynecology and Gynecologic Oncology
Department of Obstetrics and Gynecology
David Geffen School of Medicine at UCLA

Amanda Nickles Fader, MD
Director of the Kelly Gynecologic Oncology Service
Director, F.J. Montz Fellowship in Gynecologic Oncology
Johns Hopkins Medicine

G Larry Maxwell, MD, FACOG, COL(ret) U.S. Army
Chairman, Department of Obstetrics and Gynecology, Inova Fairfax Hospital
Co-P.I., DOD Gynecologic Cancer Translational Research Center of Excellence
Professor, Virginia Commonwealth School of Medicine
Executive Director, Globe-athon to End Women’s Cancer

Scott C Goodwin, MD
Hasso Brothers Professor and Chairman, Radiological Sciences
University of California, Irvine

Susan Love, MD
Dr. Susan Love Research Foundation

William E Gibbons, MD
Professor
Director, Division of Reproductive Medicine
Director, Fellowship Training
Department of Obstetrics and Gynecology
Baylor College of Medicine
Chief, Reproductive Medicine the Pavilion For Women at Texas Children’s Hospital
Houston, Texas

Leland J. Foshag, M.D., FACS
Surgical Oncology, Melanoma and Sarcoma
John Wayne Cancer Institute
Santa Monica, California

Phyllis C. Leppert, MD, PhD
Emerita Professor of Obstetrics and Gynecology
Duke University School of Medicine
President, The Campion Fund, Phyllis and Mark Leppert Foundation for Fertility Research

Judy Norsigian
Co-founder, Our Bodies, Ourselves
Boston, Mass

Charles W. Nager, MD
Professor and Chairman
Department of Reproductive Medicine
UC San Diego Health System

Timothy Johnson, MD
Chair, Department of Obstetrics and Gynecology, University of Michigan
Arthur F. Thurnau Professor, Professor of Women’s Studies, and Research Professor in the Center for Human Growth and Development

David S. Guzick, MD, PhD
Senior Vice President, Health Affairs
President, UF Health
University of Florida

Sawsan As-Sanie, MD MPH
Assistant Professor
Director, Minimally Invasive Gynecologic Surgery and Fellowship
Director, Endometriosis Center
University of Michigan

Richard J. Paulson, MD
Alia Tutor Chair in Reproductive Medicine
Professor and Vice-Chair
Department of Obstetrics and Gynecology
Chief, Division of Reproductive Endocrinology and Infertility
Keck School of Medicine
University of Southern California

Professor Cindy Farquhar
Department of Obstetrics and Gynaecology and National Women’s Health
University of Auckland, NZ

Linda Bradley, MD
Vice Chair of Obstetrics, Gynecology and Women’s Health Institute
Director of The Fibroid and Menstrual Disorders Center
Cleveland Clinic
Dept of Obstetrics and Gynecology

Stacey A. Scheib, MD
Assistant Professor
Director of the Hopkins Multidisciplinary Fibroid Center
Director of Minimally Invasive Gynecologic Surgery
Johns Hopkins Hospital

Anton J. Bilchik, MD, PhD, FACS
Professor of Surgery
Chief of Medicine at John Wayne Cancer Institute
Santa Monica, California

Laurel W. Rice, MD
Chair of the Department of Obstetrics and Gynecology
Professor, Division of Gynecology Oncology
University of Wisconsin-Madison School of Medicine and Public Health

Carla Dionne
Founder, National Uterine Fibroid Foundation

Alison Jacoby, MD
Director, UCSF Comprehensive Fibroid Center
Interim Chief, Division of Gynecology
University of California, San Francisco

Charles Ascher-Walsh, MD
Director of Gynecology, Urogynecology, MIS
Mt. Sinai School of Medicine
New York, NY

Sarah J. Kilpatrick, MD, PhD
Chair, Department of Obstetrics and Gynecology
Associate Dean, Faculty Development
Helping Hand of Los Angeles Chair in Obstetrics and Gynecology
Cedars-Sinai Medical Center
Los Angeles, California

David Adamson, MD
Clinical Professor, Stanford University School of Medicine
Past President of the American Society for Reproductive Medicine

Matthew Siedhoff, MD MSCR
University of North Carolina at Chapel Hill
Obstetrics & Gynecology
Minimally Invasive Gynecologic Surgery, Director

Robert Israel, M.D
Professor, Department of OB/GYN
Chair, Quality Improvement
Director, Women’s Health Clinics and Referrals, LAC+USC Medical Center

Marie Fidela Paraiso, MD
Head, Female Pelvic Medicine & Reconstructive Surgery
Cleveland Clinic
Cleveland, OH

Michael M. Frumovitz, M. D., M.P.H., FACOG, FACS
Fellowship Program Director
Department of Gynecologic Oncology and Reproductive Medicine
The University of Texas MD Anderson Cancer Center

John R Lurain, MD
Marcia Stenn Professor of Gynecologic Oncology
Program director for the fellowship in gynecologic oncology
Northwestern University Feinberg School of Medicine

Ayman Al-Hendy  MD PhD FRCSC FACOG CCRP
GRU Director of Interdisciplinary Translational Research
MCG Assistant Dean for Global Translational Research
Professor and Director
Division of Translational Research
Department of Obstetrics and Gynecology
Medical College of Georgia
Georgia Regents University

Guy I. Benrubi, M.D.
Senior Associate Dean for Faculty Affairs,
Robert J. Thompson Professor and Chair,
Department of Obstetrics and Gynecology
University of Florida College of Medicine – Jacksonville

Steven S. Raman, MD
Professor of Radiology, Urology, and Surgery
Co-director of the Fibroid Treatment Program
David Geffen School of Medicine at UCLA

Rosanne M Kho MD
Associate Professor
Head, Section of Urogynecology and FPMRS
Co-Director, MIGS Fellowship Program
Columbia University Medical Center
New York, NY

Ted L. Anderson, M.D., Ph.D.
Betty and Lonnie S. Burnett Professor and Chair, Obstetrics and Gynecology
Division Director, Gynecology
Vanderbilt University School of Medicine

Kevin Reynolds, MD, FACS, FACOG
The George W. Morley Professor and Chief
Division of Gynecologic Oncology
University of Michigan
Ann Arbor Michigan

John DeLancey, MD
Norman F. Miller Professor of Obstetrics & Gynecology
University of Michigan Health System

All institutional affiliations are for identification purposes only

No signee has declared a conflict of interest


References

Bojahr B, De Wilde R, Tchartchian G.  Malignancy rate of 10,731 uteri morcellated during laparoscopic supracervical hysterectomy (LASH). Arch Gynecol Obstet 2015;292:665-672.

Kosary CL. SEER survival monograph: Cancer survival among adults: U.S. SEER program, 1988-2001, patient and tumor characteristics. In: Ries LAG, Young JL, Keel GE,

Eisner MP, Lin DY, Horner MD, eds. Cancer of the corpus uteri. Bethesda, MD: National Cancer Institute, SEER Program, NIH; 2007:123-32.

Harris JA, Swenson CW, Uppal S, Kamdar N, Mahnert N, As-Sanie S, Morgan DM. Practice Patterns and Postoperative Complications Before and After Food and Drug Administration Safety Communication on Power Morcellation. Am J Obstet Gynecol (2015), doi:10.1016/j.ajog.2015.08.047.

Leung F, Terzibachian J. Re: “The impact of tumor morcellation during surgery on the prognosis of patients with apparently early uterine leiomyosarcoma [letter]. Gynecol Oncol 2012;124:172-3

Lieng M, Berner E, Busund B. Risk of morcellation of uterine leiomyosarcomas in laparoscopic supracervical hysterectomy and laparoscopic myomectomy, a retrospective trial including 4791 women. J Minim Invasive Gynecol. 2015;22:410-4

Morice P, Rodriguez A, Rey A, Pautier P, Atallah D, Genestie C, Pomel C, Lhommé C, Haie-Meder C, Duvillard P, Castaigne D. Prognostic value of initial surgical procedure for patients with uterine sarcoma: analysis of 123 patients. Eur J Gynaecol Oncol. 2003;24:237-40.

Oduyebo T, Rauh-Hain AJ, Meserve EE, Seidman MA, Hinchcliff E, George S, Quade B, Nucci MR, Del Carmen MG, Muto MG. The value of re-exploration in patients with inadvertently morcellated uterine sarcoma. Gynecol Oncol. 2014;132:360-5.

Park JY, Park SK, Kim DY, Kim JH, Kim YM, Kim YT, Nam JH. The impact of tumor morcellation during surgery on the prognosis of patients with apparently early uterine leiomyosarcoma. Gynecol Oncol. 2011;122:255-9.

Perri T, Korach J, Sadetzki S, Oberman B, Fridman E, Ben-Baruch G. Uterine leiomyosarcoma: does the primary surgical procedure matter? Int J Gynecol Cancer. 2009;19:257-60

Pritts E, Vanness D, Berek  J, Parker W, Feinberg R, Feinberg J, Olive D. The prevalence of occult leiomyosarcoma at surgery for presumed uterine fibroids: a meta-analysis. Gynecol Surg. accessed on-line 5/30/15 at: http://link.springer.com/article/10.1007/s10397-015-0894-4

Pritts E, Parker W, Brown J, Olive D. Outcome of occult uterine leiomyosarcoma after surgery for presumed uterine fibroids: a systematic review. J Minim Invasive Gynecol. 2015;22:26-33

Rowland M, Lesnock J, Edwards R, Richard S, Zorn K, Sukumvanich P, et al. Occult uterine cancer in patients undergoing laparoscopic hysterectomy with morcellation (abstract) Gynecol Oncol 2012;127:S29

Siedhoff MT, Wheeler SB, Rutstein SE, Geller EJ, Doll KM, Wu JM, Clarke-Pearson DL. Laparoscopic hysterectomy with morcellation vs abdominal hysterectomy for presumed fibroid tumors in premenopausal women: a decision analysis.  J Obstet Gynecol. 2015;212:591.e1-8

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Efficacy and safety of repeated use of ulipristal acetate in uterine fibroids

Authors: Donnez J, and others

Journal: Fertility & Sterility. 2015 Feb;103:519-27

Study From: Brussels, Belgium and 12 other European medical centers

Problem:  Ulipristal, currently available in Europe and Canada, is an oral medication that blocks the action of progesterone on fibroids and stops heavy bleeding and decreases the size of fibroids. In an earlier study of this medication, it was shown to be effective for 13 weeks of treatment without worrisome side-effects.  The current study examined whether the medication was still safe if women were given 3 months of treatment followed by 2 months off the medication and then another 3 months of treatment.

Study:  451 women with symptomatic uterine fibroids and heavy bleeding were given 3 months of treatment, followed by 2 months off the medication, followed by another 3 months of treatment.

Results: About 70% of women had no bleeding while on the medication and women did resume periods (but, lighter bleeding than before any treatment) during the two months they were off of the medication.  After the second treatment, fibroids had decreased in size by about 50%. Less than 5% of patients stopped the medication due to side-effects.  Pain and quality-of-life improved for most women.

Authors’ Conclusions:  Repeated 3 month treatments with daily oral ulipristal effectively controlled bleeding and pain, reduced fibroid volume, and restored quality-of-life in women with symptomatic fibroids.

Dr. Parker’s Comments:

Ulipristal appears to be a promising medication for the treatment of the symptoms often associated with fibroids: heavy bleeding and pelvic/abdominal pressure or pain.  An earlier study found the medication was safe for 13 weeks and the current study shows it is safe and effective when given 3 months on, two months off and three months on again.

In a normal menstrual cycle, the ovaries make estrogen in the beginning of the cycle which stimulates the uterine lining cells to grow. When ovulation occurs in the middle of the cycle, the ovary starts to produce progesterone in addition to the estrogen.  Progesterone makes the lining cells stop growing and gets the cells ready for implantation of a fertilized egg.  Up to now, most medications that block the action of progesterone have been shown to cause an overgrowth of the uterine lining cells because there is no brake on the cells’ growth.  The fear has been that this overgrowth could lead to cancer (a severe overgrowth) of the uterine lining cells.   However, with the two months off medication in between the treatments, this does not appear to happen.

My sense is that this medication will be an excellent treatment option for women who are close to menopause.  Once menopause starts, the ovaries stop making estrogen and progesterone so that all bleeding stops and fibroids usually shrink.  It remains to be seen whether long treatment (many months or years) will continue to be safe, but this medication does look very promising.  This medication is not yet available in the US, but is available in Europe, Canada and many other countries.

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Dr. Parker’s Discharge Instructions and Suggestions after Open Abdominal Surgery

UCLA Gyn Subspecialties Group
1450 Tenth Street, Suite 404
Santa Monica, CA 90401
(310) 451 8144 (phone)

Disclaimer: it is important for you to follow your own doctor’s instructions.

HOSPITAL RECOVERY

In the hospital, the nurses will remove the bladder catheter a few hours after surgery and they will ask you to sit in a chair and walk to the bathroom the night of surgery.  You will have the ON-Q pain pump (see below), but if you need other pain medication, ask the nurses and they will give it to you.  By the morning after surgery, you will be eating regular food and you will be able to walk in the hall.  Recent studies of this “enhanced surgical recovery” show that a quicker return to normal activities and diet was associated with faster patient recovery and a shorter hospital stay.

ACTIVITY AFTER SURGERY:

  • No strenuous exercise or intercourse for 4-6 weeks
  • You may start walking for exercise on day 1
    • Walking is the best activity following surgery.  You can walk up and down stairs, outside, and on a treadmill.  Walking will keep your circulation going and build back your stamina.
  • Fatigue: fatigue is extremely common after surgery and may last many weeks.
  • Iron – to help build back any blood lost during surgery. Either Fergon or SlowFe – 1-3 times a day along with 1,000mg of vitamin C (helps with the absorption of iron)
  • You may start driving when you are no longer taking narcotic pain medication and you feel it is SAFE for you to drive.
  • Showers only (no baths) for the first 2 weeks

PAIN/DISCOMFORT MANAGEMENT

  • For pain, we will prescribe either Norco 5/320mg or Percocet 5/325mg for you to take once you get home.
  • Days 2-3 may be worst, pain-wise
  • Some cramping and shooting pains are normal, even in areas away from the incisions
  • Do not drive under the influence of narcotic pain medication
  • “ON-Q” pain pump: I use an innovative device to relive post-operative pain called the ON-Q pain pump. As we are closing the incision, two tiny plastic tubes are inserted underneath the incision. The tubes are connected to a tennis ball sized pump that holds a solution of local anesthesia.  The pump slowly and automatically pushes the local anesthetic into the incision – exactly where you need it You don’t need to touch it). The ON-Q pump greatly reduces the need for injected narcotic pain medication doesn’t cause the grogginess that often accompanies narcotics.  The device lasts 3-4 days and then is easily, and absolutely painlessly, removed in the office when the suture is removed.
  • Lowering, raising and turning yourself will hurt (try using your arms instead of abs)
  • Urination may burn/pinch initially, but will get easier (avoiding caffeine). Taking D-Mannose helps.

PERIODS

  • Some bleeding and/or clumpy discharge is normal for a few weeks.
  • Periods won’t be normal again for 3-4 cycles

CALL US AT 310-451-8144 FOR:

Fever over 100.4 degrees F, bad pain unrelieved by pain medications, heavy bleeding, vomiting, dizziness, pus-like drainage from the wound or other concerns.

 DIET AND BOWEL ISSUES

  • No dietary restrictions
    • Avoid foods that cause gas such as broccoli, cauliflower and brussel sprouts
  • No alcohol if taking narcotic pain medications
  • Chewing gum helps with bowel function
  • Walking helps bowel function
  • Constipation is normal for a few days after abdominal surgery.  You may take Metamucil (fiber) or colace as needed.
  • Expect some gas discomfort/pain.  Gas pain can be relieved by walking, taking medication (Mylicon, Gas-X) and chewing gum.  Bending your legs while lying on your back may also help.
  • Bloating (“swelly belly”) is normal for up to 6-8 weeks and will go away by itself.  Surgery irritates and slows down the intestines and they retain more gas and stool. Some women find that an abdominal binder reduces pressure on the incision and helps them feel more support.  You can buy an abdominal binder at a surgical supply store or pharmacy.

INCISION HEALING

  • Skin incision – I close the skin incision with a suture technique that I learned from a plastic surgeon.  I use one continuous suture that is removed about 5-7 days after surgery, so that no suture material is left under the skin.  This technique decreases the chance of a thick scar.  I then place steri-strips (like band-aids) across the incision to take the tension off of the skin, which also decreases the risk of a thick scar.  The suture is quickly and painlessly removed in the office by our nurses and, if needed, the steri-strips are   replaced.  There are many layers of suture below the skin holding the incision together and these sutures dissolve a few months after surgery.
  • It is OK to shower with steri-strips (do not scrub the wound). You can remove the steri-strips after a week. After the steri-strips are removed, I suggest you buy Scar Away at the drug store.  Scar away is a silicon bandage (like a large band-aid) and you keep it on the incision for as many hours a day as you can.  Over time, the scar away thins and lightens the incision so that it heals more nicely.
  • Bruising: bruising around the incision(s) is very common, even beyond the surgery area, for a few weeks after surgery.  Cold packs can keep the incision swelling down and the bruising will go away by itself.
  • Incision “Shelf”: the first scar tissue that forms in the incision is made up of a thick, stiff collagen, which pulls the scar inward and leads to a “shelf” over the incision.  Over the next 3-6 months, the first collagen is slowly replaced by a more elastic collagen and the incision becomes flat with the rest of the skin.
  • Numbness: when we make the initial incisions to get to the uterus, we stretch, tear or even cut the very small nerves that go to the skin on the abdomen.  As a result, it is very common to have numbness, tingling, burning or itching above the incision for a few months after surgery.

APPOINTMENTS AFTER SURGERY:

  • Suture and ON-Q pain pump removal 5-7 days after surgery – with Dr. Parker’s nurse or nurse practitioner
  • Appointment with Dr. Parker 2 weeks after surgery
  • Appointment with Dr. Parker 6 weeks after surgery

SUGGESTED TO WEAR/BRING TO THE HOSPITAL

  • Comfortable slip-on flat shoes
  • Pants or skirt with elastic or drawstring waistband
  • Pillow for the car ride home (leave in car to put between your stomach and seat belt)
  • Lip balm (your mouth may be parched)
  • Your ID
  • Advance directives (optional)

BEFORE SURGERY –  SUGGESTED SHOPPING LIST

  • Throat lozenges: Sometimes the tube placed down your windpipe (trachea) can cause irritation which can feel like a sore throat.   At times, this irritation can lead to a not very pleasant feeling cough.  Lozenges can help soothe your throat and also help minimize the coughing.
  • Stool softener: Many types are available:  Smooth Move tea, Colace, Peri-Colace (stool softener and mild laxative together).  High-fiber foods.
  • Anti-gas pains: Mylicon, Maalox, Gas-X or peppermint tea
  • Three days of groceries/easy-prep foods, since you won’t feel like cooking. Consider broth/soup, fruits + veggies (avoid gassy ones like broccoli, cauliflower and Brussels sprouts), rice, crackers, juice, yogurt.

BEFORE MYOMECTOMY

We ask women to insert 2 tablets (Cytotec) vaginally about  2 hours before surgery. Cytotec has been shown to decrease blood loss during myomectomy surgery.  However, it can also cause cramping, vaginal bleeding and, sometimes nausea.   If you have any of these symptoms, they are normal (and we apologize), but the medication does help decrease surgical blood loss.

View all blog archives

Dr. Parker’s Discharge Instructions and Suggestions after Laparoscopic Surgery

UCLA Gyn Subspecialties Group
1450 Tenth Street, Suite 404
Santa Monica, CA, 90401
(310) 451 8144 (phone)

Disclaimer: it is important for you to follow your own doctor’s instructions.

ACTIVITY AFTER SURGERY:

  • No strenuous exercise or intercourse for 2 weeks
  • You may start walking for exercise on day 1
    • Walking is the best activity following surgery.  You can walk up and down stairs, outside, and on a treadmill.  Walking will keep your circulation going and build back your stamina.
  • Fatigue – fatigue is extremely common after surgery and may last many weeks.
  • Iron – to help build back any blood lost during surgery. Either Fergon or SlowFe – 1-3 times a day along with 1,000mg of vitamin C (helps with the absorption of iron)
  • You may start driving when you are no longer taking narcotic pain medication and you   feel it is SAFE for you to drive.
  • Showers only (no baths) for the first 2 weeks.

PAIN/DISCOMFORT MANAGEMENT

  • For pain, we will prescribe either Norco 5/320mg or Percocet 5/325mg for you to take once you get home.
    • Days 2-3 may be worst, pain-wise
    • Some cramping and shooting pains are normal, even in areas away from the incisions
    • Do not drive under the influence of narcotic pain medication
  • Lowering, raising and turning yourself will hurt (try using your arms instead of abs)
  • Urination may burn/pinch initially, but will get easier (avoiding caffeine). Taking D-Mannose helps.
  • Shoulder Pain – In order to see the pelvic organs during laparoscopic surgery, we need to put carbon dioxide gas (CO2) into the abdomen which pushes the bowel out of the way.  If the CO2 is left in the abdomen, it can irritate the nerve under the diaphragms.  This nerve runs close to the nerves for your shoulder and the gas will cause shoulder and back pain.  The pain can be sharp and can last for a day or two.  Sometimes changing position can help, but over time the pain will go away.

INCISIONS

Depending on the type of laparoscopic surgery you have, you will have either 2, 3 or 4 small incisions.  Usually the first 1/2 inch incision is made in the navel.  For a laparoscopic myomectomy, a 1/3 inch incision is made a few inches to the left of the navel and another incision is made a few inches to the right side of the navel.  The last incision is about 3/4 inch and is placed on the right side above the hip bone.  For larger fibroids, the incisions will be higher.  For laparoscopic hysterectomy the right side smaller incision is not necessary.

At the end of the surgery, I inject local anesthesia into the incisions which provides a few hours of some pain relief.  You will likely have some pain in the recovery room and then nurses will give you pain medication as needed. When the local anesthesia wears off, you will have some incisional pain and, during your pre-op visit to the office, we will give you a prescription for pain medication to take at home.  The larger incision on the right side tends to be uncomfortable for a few weeks since it is larger, gets more sutures and is close to a nerve.

  • It is OK to shower with steri-strips (do not scrub the wounds). You can remove the steri-strips after a week. After the steri-strips are removed, I suggest you buy Scar Away at the drug store. Scar away is a silicon bandage (like a large band-aid) that you can cut into small strips and put over the incisions for as many hours a day as you can.  Over time, the Scar Away thins and lightens the incisions so that they heal more nicely.
  • Bruising: bruising around the incision(s) is very common, even beyond the surgery area, for a few weeks after surgery.  Cold packs can keep the incision swelling down and the bruising will go away by itself.
  • Lumpy Incisions – the sutures dissolve by themselves and are replaced by collagen scar tissue.  Initially, the collagen is thick and may be bumpy.  Over the next few months the initial collagen is replaced by a softer type of collagen and the bumps will go away.

DIET AND BOWEL ISSUES

  • No dietary restrictions
    • Avoid foods that cause gas such as broccoli, cauliflower and brussel sprouts
  • No alcohol if taking narcotic pain medications
  • Chewing gum helps with bowel function
  • Walking helps bowel function
  • Constipation is unusual after laparoscopic surgery.  But, if you have constipation you may take Metamucil or Colace as needed (over-the-cunter).
  • Expect some gas discomfort/pain.  Gas pain can be relieved by walking, taking medication (Mylicon, Gas-X) and chewing gum.  Bending your legs while lying on your back may also help.
  • Bloating (“swelly belly”) is normal for up to 2-4 weeks and will go away by itself. Surgery irritates and slows down the intestines and they retain more gas and stool.

PERIODS

  • Some bleeding and/or clumpy discharge is normal for a few weeks.
  • Periods won’t be normal again for 3-4 cycles – they may be heavy, light, long, short – anything can happen while you are healing.

 CALL US AT 310-451-8144 FOR:

Fever over 100.4 degrees F, bad pain unrelieved by pain medications, heavy bleeding, vomiting, dizziness, pus-like drainage from the wound or other concerns.

 SUGGESTED TO WEAR/BRING TO THE HOSPITAL

  • Comfortable slip-on flat shoes
  • Pants or skirt with elastic or drawstring waistband
  • Pillow for the car ride home (leave in car to put between your stomach and seat belt)
  • Lip balm (your mouth may be parched)
  • Your ID
  • Advance directives (optional)

BEFORE SURGERY –  SUGGESTED SHOPPING LIST

  • Throat lozenges: Sometimes the tube placed down your windpipe (trachea) can cause irritation which can feel like a sore throat.   At times, this irritation can lead to a not very pleasant feeling cough.  Lozenges can help soothe your throat and also help minimize the coughing.
  • Stool softener: Many types are available:  Smooth Move tea, Colace, Peri-Colace (stool softener and mild laxative together).  High-fiber foods.
  • Anti-gas pains: Mylicon, Maalox, Gas-X or peppermint tea
  • Three days of groceries/easy-prep foods, since you won’t feel like cooking. Consider broth/soup, fruits + veggies (avoid gassy ones like broccoli, cauliflower and Brussels sprouts), rice, crackers, juice, yogurt.

BEFORE MYOMECTOMY

We ask women to insert 2 tablets (Cytotec) vaginally about  2 hours before surgery. Cytotec has been shown to decrease blood loss during myomectomy surgery. However, it can also cause cramping, vaginal bleeding and, sometimes nausea. If you have any of these symptoms, they are normal (and we apologize), but the medication does help decrease surgical blood loss.

View all blog archives

An Association between Thyroid Disease and Fibroids

Overt hypothyroidism is associated with the presence of uterine leiomyoma: a retrospective analysis. Eur J Obstet Gynecol Reprod Biol. 2014 Jun;177:19-22.

Authors: Ott J, Kurz C, Braun R, Promberger R, Seemann R, Vytiska-Binstorfer E, Walch K.

Study from: Medical University of Vienna, Vienna, Austria.

Problem: Few studies have examined the relationship between low thyroid function and the presence of uterine fibroids.

Study: 215 infertile women who had gynecologic surgery between 2007 and 2011 were studied. All fibroids that were suspected on ultrasound were confirmed during surgery. The authors calculated whether the 51 women with fibroids were more likely to: have thyroid disease; be older; be of African heritage; be older at the time of their first menstrual period; have more children, :or, be overweight.

Results: Women of African heritage were more likely to have fibroids and women with underactive thyroid (hypothyroidism) were 3 times as likely to have fibroids as women without hypothyroidism. Larger fibroids were found in women with hypothyroidism than in those women without hypothyroidism.

Authors’ Conclusions: Women with an underactive thyroid were more likely to have fibroids than women with normal thyroid function.

Dr. Parker’s Comments:

A number of women have asked me about the association of fibroids and thyroid disease, but I had been unaware of any studies that had reported this. However, this study does show that women with underactive thyroids are at a higher risk of having fibroids. This is an association and does not mean that thyroid disease causes fibroids, nor would treating thyroid disease be expected to reduce the chances of getting fibroids. The current (unproven) theory is that something in the body, perhaps proteins associated with chronic inflammation, can lead to both thyroid disease and fibroids. Until more is known about this association, it might make sense for women with fibroids to have their thyroid hormone level checked with a blood test.

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Safety and five-year re-intervention following magnetic resonance-guided focused ultrasound (MRgFUS) for uterine fibroids

Authors:  Quinn, S, Vedelago J, Gedroyc W, Regan L.

Journal:  Europeam Journal of Obstetrics & Gynecology and Reproductive Biology

Study From:  London, England

Problem:  While MRgFUS (also called high intensity focused ultrasound or HIFU) is not new, the results of treatment over the long-term have not been reported in the medical literature.

Study:  Following treatment with MRgFUS (HIFU), 280 women were evaluated for complications from the treatment. Five years after treatment, 162 of those women were evaluated to determine if another treatment had been needed to resolve fibroid symptoms.

Results:  Three women had serious complications (1.1%) including one woman with a skin burn that required surgical repair, one woman with a fibroid that passed through the vagina following treatment and one woman with a persistent nerve injury.   Of the 162 women who had  5 years of follow-up, 59% needed another type of treatment to give them symptom relief.  When more than half of the fibroid volume was able to be treated, 50% of women needed an additional treatment to deal with their symptoms.

Authors’ Conclusions:  MRgFUS  (HIFU) treatment of uterine fibroids is a safe treatment for uterine fibroids. The re-intervention rate at 5 years is high, but improvements in technique may further improve the long-term results.

Dr. Parker’s Comments:

High intensity focused ultrasound seems like an ideal treatment for fibroids; for most women it is painless, treatment requires no anesthesia and the recovery requires essentially no time off from work or family.  However, the results of treatment have been disappointing.   Early on, when the technology was new, the FDA only allowed small areas of the fibroids to be treated to make sure the technique was safe.  Therefore, the symptom relief was understandably limited.  More recent studies have treated more of the fibroid volume with seemingly better results.

But, even new  MRgFUS  (HIFU) techniques are not able to treat the entire fibroid volume raising the question: is this good enough?  This study suggests that while MRgFUS (HIFU) appears to be safe, many women need other treatment to deal with persistent fibroid symptoms.  Although I am rooting for this technique because of its non-invasive approach and quick recovery, I think it is still not effective enough for the majority of women with fibroids.

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Why not biopsy fibroids before surgery to make sure they are not cancer?

Some people have recently suggested that all women have biopsies of their fibroids before surgery to determine which women have typical fibroids and which women might have a leiomyosarcoma (LMS). There are many problems with this idea.

To start, I am going to use the word tumor throughout this post. When we hear” tumor”, most of us (doctors included) think “cancer”. However, “tumor” means a growth and a growth can be benign or it can be malignant. Fibroids are a very common benign tumor of the uterine muscle cells (75% of women have them by age 50). Leiomyosarcoma is a very rare malignant tumor (see previous post) that starts in the uterine muscle wall. No one knows the causes of either fibroids or LMS, but it is now fairly well established that fibroids do not turn into LMS.

Fibroids are made up of uterine muscle cells, but also contain collagen and other proteins called proteoglycans. When the pathologist looks at a fibroid under the microscope, they see muscle cells that are very similar to one another and the cells appear to be dividing very slowly (very few mitoses). The diagnosis of fibroids is very easy for a pathologist to make.

The diagnosis of LMS under the microscope, however, is very hard. In order to make the diagnosis of a leiomyosarcoma many changes in the muscles cells need to be present: abnormal appearing cell nuclei (atypia); many cells that are dividing (mitoses); invasion of the cells into the surrounding tissue; breakdown of the cells (necrosis) and other features. All of these features need to be seen by the pathologist in order to make the diagnosis of LMS .

Another characteristic of LMS is that it is a very uneven tumor (heterogeneous), meaning that the cells can look almost normal in one area but very abnormal and aggressive in another area. Often, many areas of the tumor need to be examined before a diagnosis of a benign fibroid, atypical fibroid (mild abnormality) or LMS ( malignant) can be made. Even good pathologists can have trouble making the diagnosis of LMS because they see so very few of these tumors in their lifetimes. In my practice, whenever we have had any question about the diagnosis of a unusual-looking fibroid, I have the tissue sent for a second opinion to the world’s expert LMS pathologists at Stanford, Drs. Kempson and Hendrickson.

The next issue is that biopsy of fibroids before surgery would involve finding the fibroids using ultrasound, placing a needle through the abdominal wall into the uterus and fibroid, applying suction to collect cells and then withdrawing the needle and placing the cells into a container for the pathologist. The problem with a needle biopsy of a “fibroid” is that the needle will get a sample of only one very small area of the fibroid and there will be very few cells for the pathologist to examine. If the cells in that particular area look uniform, then the diagnosis will be fibroid, even if another area that has not been biopsied looks very abnormal and is, in fact, a LMS. Furthermore, frozen section, where a piece of tissue is removed from the tumor during surgery, immediately frozen, prepared and then examined by the pathologist is also very inaccurate because the freezing process distorts the LMS cells, which are already hard to diagnose. Proper preparation of the slides takes many hours.

An added problem is that most women have more than one fibroid. I have removed 150 fibroids from one woman (very unusual) and often need to remove more than 20. It would be technically impossible to biopsy every fibroid, and no woman would be able to tolerate the discomfort from multiple biopsies unless they were put to sleep with general anesthesia.

Because of all of these limitations, biopsying of “fibroids” is neither reasonable nor would it be accurate. That’s why we don’t do it.

 

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How Often Does Morcellation Involve Cancers other than LMS?

A recent article in the Journal of the American Medical Association (JAMA) reported that the rate of uterine cancer among women having surgical procedures using morcellation was 1 woman out of 368. Since the recent FDA hearing was about morcellation and the risk of finding uterine leiomyosarcoma (LMS), some of the media have misinterpreted this number to mean that 1 out of 368 women who had a morcellation procedure were found to have a LMS.

The authors reviewed 6 years of data from an insurance company’s database of 500 hospitals and found 36,470 women who had procedures with morcellation during that time. Then they determined how many of these women had a final diagnosis of any type of uterine cancer. Over the 6 years, 99 of the 36,470 women were found to have any kind of uterine cancer. However, the authors did not determine how many of these women had leiomyosarcomas and how many had the more common (and usually less dangerous) types of uterine cancers such as uterine lining cell cancer.

The US Center for Disease Control (CDC) states that uterine lining cell cancers make up 97% of all uterine cancers, and uterine leiomyosarcomas (LMS) make up about 2-3% of all uterine cancers (other uterine sarcomas are even more rare). If we apply these percentages to the JAMA study, and we do the math, then 3% of the 99 cancers found in the JAMA study means 3 women with LMS were found among the 36,470 women who had morcellation. That means 1 woman with LMS for every 12,279 women (0.008%) who had morcellation. This number is even lower than the rate calculated in Dr. Pritts’ study (see earlier post) and is much lower than the rate calculated in the sub-optimal analysis done by the FDA, which calculated a risk 27 times higher.

Nevertheless, gynecologists and women who are considering hysterectomies with morcellation may have something important to learn from the JAMA study. If 96 cancers of the uterine lining (endometrial cancer) were not detected or suspected prior to surgery, then gynecologists may not be doing the best job of evaluating women with this disease, or our current testing methods are not working very well. While we currently do not have a way of detecting LMS before surgery, we do have ways to detect uterine lining cell cancers before surgery. Many women with fibroids have heavy vaginal bleeding with their periods. Many women with uterine lining cell cancer have irregular bleeding before menopause or have bleeding after menopause when bleeding is supposed to have stopped. If women have irregular bleeding, we have ways to detect uterine lining cancer in the office.

Trans-vaginal pelvic ultrasound can measure the thickness of the uterine lining fairly accurately and MRI, while more expensive, is also very accurate to measure the lining cell thickness. If the lining is normal thickness (“normal” will depend on whether you are pre-menopausal or post-menopausal), then the risk of having uterine lining cancer is very, very small. If the lining measures thicker than normal, the causes may be benign polyps, a fibroid inside the uterine cavity, benign overgrowth of the lining cells (benign hyperplasia), pre-cancer of the uterine lining cells (atypical hyperplasia) or uterine cancer.

If the lining is thick, then the next step is either an endometrial biopsy in the office or a full D&C, often in an outpatient surgery center. Both of these procedures remove lining cells for analysis by the pathologist, and both are very accurate, although not quite 100%. The unanswered question raised by the JAMA article is whether gynecologists are not appropriately evaluating women for uterine lining cancers before hysterectomies or whether ultrasound, MRI, endometrial biopsy and D&C do not detect these cancers as well as we thought.

We obviously need more research to find a way to diagnose leiomyosarcomas before surgery – this should be one critical outcome of the current FDA hearing. We also need to heed this study as a call for gynecologists to consider the diagnosis of uterine lining cell cancer more often and make sure we do the proper testing before surgery, and certainly before morcellation. If you have questions about whether you should have testing for uterine cancer before surgery, ask your doctor to discuss this with you.

Next post: Why not biopsy fibroids to make sure they are not cancer?

 

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Disclaimer: The ideas, procedures and suggestions contained on this web site are not intended as a substitute for consulting with your physician. All matters regarding your health require medical supervision.

Fibroid Doctor William H. Parker

Dr. William H. Parker is a board-certified Fellow in the American College of Obstetricians and Gynecologists. Dr. Parker is an internationally recognized expert in fibroid surgery and research. Based in Los Angeles, California, he is considered one of the best fibroid surgeons for abdominal and laparoscopic myomectomy in the United States and abroad. He has been chosen for Best Doctors in America and Top Doctors every year beginning in the late 90's.

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