20 OPINION OCTOBER 2010 • OB.GYN.

NEWS

COMMENTARY
Treating Endometriosis Successfully
xcision I was able to surgically treat extensive Here’s a brief summary of my surgi- the pelvic organs. The next step is to sep-

E biopsy of
suspected
lesions is used by
endometriosis over the past 30 years only
because I did not participate within the
managed care insurance system.
cal approach. Many women with exten-
sive endometriosis have had multiple
abdominal incision laparotomies that
arate all pelvic organs including the
ovaries, uterus, cervix, upper vagina,
and rectum. The last step is to excise the
experts to diag- Over time, two distinct groups of result in adhesions of small bowel stuck endometriosis.
H A R RY nose endometrio- laparoscopic surgeons have evolved: a to the undersurface of the anterior Symptomatic endometriosis is
R E I C H , M . D. sis, but a reluc- very large cluster doing it for diagnosis abdominal wall. Thus, the first part of surrounded by fibrotic scar tissue from
tance to biopsy and minimal treatment and a much many endometriosis operations is to the repetitive longstanding inflammatory
by many ob.gyns., who make the diag- smaller elite segment doing it for opti- release small-bowel adhesions from the response. This scar tissue containing the
nosis visually by laparoscopy, means a mum treatment. anterior abdominal wall in order to see endometriotic glands is excised from
distortion of results. A diagnosis of endo-
metriosis should require a positive
excisional biopsy documenting endo-
metrial glands/stroma at laparoscopy.
Papers in the literature using visual
documentation of endometriosis are Now Approved
worthless. Yes, I am saying that most
papers on the medical and/or surgical
treatment of endometriosis without
biopsy are worthless. Many women with
a clinical or visual diagnosis of
endometriosis without biopsy do not
have endometriosis; they are more like-
ly being treated for “hemosiderin-laden
macrophages,” the normal product of
retrograde menstruation.
In most cases of severe endometriosis,
the endometriosis – surrounded by scar
tissue – can be palpated in the office us-
ing a simple rectovaginal examination.
These areas are usually very tender to
palpation, and this tenderness is used to
direct the surgeon to the area to be
removed.
Postoperative examination (3-6
months after surgery) should be pain free
if the appropriate area was excised.
Unfortunately, many women who
undergo multiple “endometriosis”
laparoscopies actually have minimal
disease. Surgeons will typically perform
diagnostic laparoscopy without biopsy
followed by 6 months of gonadotropin-
releasing hormone (GnRH) agonist treat-
ment followed by another “diagnostic”
laparoscopy. This is what I call “cashec-
tomy” – extracting cash from the patient Image of trabecular bone insert reproduced with
permission from David W. Dempster, PhD.
without any long-term benefit because
the disease remains. The concept that en-
dometriosis comes back is often a good
excuse for poor treatment. What is called
recurrent disease is really persistent
disease that was never treated in the first INDICATION
Prolia™ is indicated for the treatment of postmenopausal the abdomen, urinary tract and ear, were more frequent
place. women with osteoporosis at high risk for fracture, in patients treated with Prolia™. Endocarditis was also
If this paints a depressing picture about reported more frequently in Prolia™-treated subjects.
defined as a history of osteoporotic fracture, or multiple The incidence of opportunistic infections was balanced and
the state of endometriosis diagnosis and risk factors for fracture; or patients who have failed or the overall incidence of infections was similar between the
treatment in the United States, believe are intolerant to other available osteoporosis therapy. treatment groups. Advise patients to seek prompt medical
me, it should. But surgeons alone are not In postmenopausal women with osteoporosis, Prolia™ attention if they develop signs or symptoms of severe
to blame. The lawyers and the managed reduces the incidence of vertebral, nonvertebral, and infection, including cellulitis.
hip fractures. Patients on concomitant immunosuppressant agents or
care insurance system have contributed.
with impaired immune systems may be at increased risk
IMPORTANT SAFETY INFORMATION for serious infections. In patients who develop serious
Hypocalcemia: ™ is contraindicated in patients
infections while on Prolia™, prescribers should assess the
LETTERS with hypocalcemia. Pre-existing hypocalcemia must need for continued Prolia™ therapy.
be corrected prior to initiating Prolia™. Hypocalcemia
Letters in response to articles in may worsen, especially in patients with severe renal Dermatologic Adverse Reactions: Epidermal and dermal
OB.GYN. NEWS and its supplements impairment. In patients predisposed to hypocalcemia and adverse events such as dermatitis, eczema and rashes
should include your name and address, disturbances of mineral metabolism, clinical monitoring occurred at a significantly higher rate in the Prolia™ group
affiliation, and conflicts of interest in of calcium and mineral levels is highly recommended. compared to the placebo group. Most of these events were
regard to the topic discussed. Letters Adequately supplement all patients with calcium and not specific to the injection site. Consider discontinuing
may be edited for space and clarity. vitamin D. Prolia™ if severe symptoms develop.
Mail: Letters, OB.GYN. NEWS, Serious Infections: In a clinical trial (N = 7808), serious Osteonecrosis of the Jaw (ONJ): ONJ, which can occur
5635 Fishers Lane, Suite 6000, infections leading to hospitalization were reported more spontaneously, is generally associated with tooth extraction
Rockville, MD 20852 frequently in the Prolia™ group than in the placebo and/or local infection with delayed healing, and has been
group. Serious
S i skin
ki infections,
i f i as well ll as infections
i f i off reported
t d in
i patients
ti t receiving P li ™. An
i i Prolia A orall exam should
h ld
Fax: 240-221-4400
E-mail: obnews@elsevier.com
O C T O B E R 2 0 1 0 • W W W. O B G Y N N E W S . C O M OPINION 21

inside the ovaries, the posterior cervix
and vagina, the rectum, and the
uterosacral ligaments (and ureters if
necessary). Rectal resection, discoid or
complete, is done if the endometriosis
penetrates the rectal and/or rectosig-
moid wall. I use 2,000 cc of Ringer’s
lactate to separate the operated-upon
organs during early healing. I do not use
GnRH agonists.
There are no fewer than 37 CPT codes
to report a hysterectomy. But there are
no codes to report an extensive
endometriosis operation like the one I
just described.
Most operations to effectively excise
extensive deep fibrotic endometriosis
take 3-4 hours. But the poor reimburse-
ment available for complex endo-
metriosis surgery and the high legal risk
means that few gynecologists will want
to acquire the skills to perform these
operations. Instead, many in our profes-
sion consider it acceptable to diagnose
endometriosis without biopsy proof and
then perform laparoscopy with minimal
treatment of the deep lesions. This
should no longer be acceptable to our
patients.
We need to develop proper guidelines
for endometriosis diagnosis and treat-
ment. Medical treatment cure rates are
near zero, regardless of disease stage,
and act mainly to suppress endometrial
gland and stroma activity.
Extensive endometriosis surgery, often
involving excising rectal lesions, is the
most difficult surgery a gynecologist en-
counters, more difficult than cancer
surgery in most cases. But endometrio-
sis is not cancer. It is a chronic inflam-
matory response to hormonally activat-
ed cells with resultant fibromuscular
encapsulation.
I believe that the development of
endometriosis subspecialty centers with
gynecologic surgeons trained to excise
bowel, bladder, and ureteral lesions is
long past due in this country. ■
DR. REICH, who performed the first
laparoscopic hysterectomy, is a past
president of both the International Society
of Gynecologic Endoscopists and the
Society of Laparoendoscopic Surgeons. He
is currently an adviser to the Endometriosis
Foundation of America. Dr. Reich has a
financial interest in Apple Medical, which
developed a trocar. E-mail him at
obnews@elsevier.com.

In Treating Your Postmenopausal Osteoporosis Patients

at High Risk for Fracture, Help . . .

BE A FORCE AGAINST FRACTURE

Prolia™ targets and binds to RANK Ligand, inhibiting osteoclast formation, function, and survival1
Prolia™ significantly reduced fracture risk at key sites in a phase 3 trial*1,2

Vertebral Fracture† Hip Fracturex Nonvertebral Fracture‡

40%
§
20%
p = 0.01
%§
68
p < 0.0001
p = 0.04

ARR|| 1.5%

||
ARR 0.3%

N = 7808
3-year, placebo-controlled trial
ARR|| 4.8%

Prolia™ is a subcutaneous injection administered every 6 months in your office1

Please see Brief Summary of Prescribing

Information on the following page.

be performed by the prescriber prior to initiation of Prolia™.
A dental examination with appropriate preventive dentistry
should be considered prior to treatment in patients with
risk factors for ONJ. Good oral hygiene practices should
be maintained during treatment with Prolia™.
For patients requiring invasive dental procedures, clinical
judgment should guide the management plan of each
patient. Patients who are suspected of having or who
develop ONJ should receive care by a dentist or an oral
surgeon. Extensive dental surgery to treat ONJ may
exacerbate the condition. Discontinuation of Prolia™ should
be considered based on individual benefit-risk assessment.
Prolia™ Postmarketing Active Safety Surveillance Program:
The Prolia™ Postmarketing Active Safety Surveillance
Program is available to collect information from
prescribers on specific adverse events. Please go to
www.proliasafety.com
p y or call 1-800-772-6436 for more
information about this program.
* Key sites: vertebral, hip, and nonvertebral.1,2
† Includes 7393 patients with a baseline and at least one post-baseline radiograph.1,2
‡ Composite measurement excluding pathological fractures and those associated with
severe trauma, fractures of the vertebrae, skull, face, mandible, metacarpals, fingers,
and toes.1,2
§ RRR = relative risk reduction.
|| ARR = absolute risk reduction.

Suppression of Bone Turnover: Prolia™ resulted in significant References: 1. Prolia™ (denosumab) prescribing information, Amgen. 2. Cummings SR,
San Martin J, McClung MR, et al. Denosumab for prevention of fractures in postmenopausal
suppression of bone remodeling as evidenced by markers of women with osteoporosis. N Engl J Med. 2009;361:756-765.
bone turnover and bone histomorphometry. The significance
of these findings and the effect of long-term treatment are
unknown. Monitor patients for consequences, including ONJ, For more information, visit www.ProliaHCP.com/ON
atypical fractures, and delayed fracture healing.
Adverse Reactions:The most common adverse reactions
(> 5% and more common than placebo) are back pain, pain
in extremity, musculoskeletal pain, hypercholesterolemia,
and cystitis. Pancreatitis has been reported with Prolia™.
The overall incidence of new malignancies was 4.3% in
the placebo and 4.8% in the Prolia™ groups. A causal
relationship to drug exposure has not been established.
Denosumab is a human monoclonal antibody. As with all
therapeutic
th ti proteins,
t i there
th is
i potential
t ti l for
f immunogenicity.
i i it ©2010 Amgen Inc.
Inc All rights reserved.
reserved
MC48223 8-10