New Developments in Contraception: Permanent Options for Women

1
New Developments in Contraception Permanent
Options for Women
Association of Reproductive Health
Professionalswww.arhp.org
2
Expert Medical Advisory Committee

• John E. Nichols, Jr., MD (chair)
• Mitchell Creinin, MD
• Kirtly Parker Jones, MD
• Susan Wysocki, RN-C, NP

Required Slide
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Learning Objectives

• Understand the history of tubal sterilization
• List pros and cons of transcervical sterilization
• Review findings of micro-insert clinical trials
• Safety
• Adverse events
• Effectiveness
• Patient satisfaction

more
4
Learning Objectives (continued)

• List at least four methods of transcervical
  permanent contraception
• Identify subgroups of women most likely to
  experience regret after tubal sterilization

5
Contraceptive Use (2002)
of US women ages 15-44
Chandra A, et al. 2005.
6
Contraceptive Use Popular Methods (2002)
of US women ages 15-44 who practice
contraception
Chandra A, et al. 2005.
7
Annual Tubal Ligations in the US (1970-1994)
Tubal ligations (in millions)
Westhoff C, Davis A. Fertil Steril. 2000. Chandra
A, et al. 2005.
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Increase of Tubal Sterilization in the US
1970s-1980s

• Laparoscopic sterilization approach
• Shorter operations
• Shorter hospital stays
• More acceptable cosmetic results
• Increased safety of anesthesia and surgery

more
Westhoff C, Davis A. Fertil Steril. 2000.
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Increase of Tubal Sterilization in the US
1970s-1980s (continued)

• Controversy about safety of oral contraception
• Withdrawal of majority of IUDs from US market
• Sterilization covered by insurance, not
  reversible methods

Westhoff C, Davis A. Fertil Steril. 2000.
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Sterilization Mortality Morbidity

• Low mortality rates
• 1991 one death in 40,337 procedures
• 1993 one death in 22,966 procedures

more
Westhoff C, Davis A. Fertil Steril. 2000.
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Sterilization Mortality Morbidity (continued)

• Morbidity affected by provider experience
• lt 100 procedures, 14.7/1,000 complications
• gt 100 procedures, 3.8/1,000 complications
• Complications include vessel laceration, bowel
  burn, tubal transection

Westhoff C, Davis A. Fertil Steril. 2000.
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US Tubal Sterilization Regret

• CREST study
• Percent of women regretting tubal sterilization
• 30 or younger 20
• Older than 30 6

Hillis SD, et al. Obstet Gynecol. 1999.
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Post-Sterilization Pregnancy Risk CREST Study
Peterson HB, et al. N Engl J Med. 1997336762-76.
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Why New Sterilization Methods?

• Some women want to end their childbearing
  potential
• Epidemic rate of unintended pregnancies
• Every woman has unique contraceptive needs
• Sterilization remains the most widely used form
  of birth control in the US

Henshaw SK. Fam Plann Perspect. 1998.
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Sterilization Tubal Ligation Methods

• Methods for accessing the fallopian tubes
• Laparotomy
• Mini-laparotomy
• Vaginal posterior colpotomy
• Laparoscopy
• Hysteroscopy

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Tubal Sterilization FDA-Approved Methods
The most widely used occlusion methods are
typically performed on the isthmic portion of the
fallopian tube

• Partial salpingectomy
• Clips
• Silicone rings
• Electrocoagulation
• Micro-insert

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Hysteroscopic Sterilization Techniques
Electrocoagulation
more
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Hysteroscopic Sterilization Techniques (continued)
Chemical
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Transcervical Sterilization Methods
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Transcervical Sterilization Advantages to the
Provider

• Outpatient procedure
• No general or regional anesthesia
• Women with certain medical conditions may be
  eligible

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Transcervical Sterilization Disadvantages to the
Provider

• Special equipment and training needed for
  insertion
• Some women may not be candidates
• Uncertainty still exists about long-term
  effectiveness and insurance coverage

22
Transcervical Sterilization Advantages to the
Patient

• No incision
• Absence of a scar preserves privacy
• Less invasive
• Less discomfort
• Faster recovery
• Efficacy

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Transcervical Sterilization Disadvantages to the
Patient

• Another contraceptive method is required for
  three months after insertion
• Non-reversible some women may experience regret

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New Tubal Occlusion MethodMicro-Insert Tubal
Occlusion (Essure)

• FDA approval in November 2002
• Only FDA approved hysteroscopic method of tubal
  sterilization available

• Placement of micro-inserts into proximal
  fallopian tubes

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Micro-Insert Design
ARHP. Clinical Proceedings. May 2002.
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Micro-Insert Mechanism of Action

• Expansion of outer coil for acute anchoring
• Space filling/mechanical blockage of tubal lumen
• Tubal occlusion by tissue in-growth into and
  around the micro-insert
• Long-term nature of tissue response not known
  beyond 24 months

Essure Prescribing Information
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Micro-Insert Clinical Trials Overview
Essure PMA Submission. October 2002.
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Micro-Insert Pivotal Trial Objectives

• Evaluate
• Safety and participants tolerance of and
  recovery from Essure procedure
• Safety and participants tolerance to implanted
  micro-insert
• Tubal occlusion by HSG at 3 months
• Effectiveness in preventing pregnancy

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Micro-Insert Placement Reliance Rates Phase II
227 Women
198 Occluded at 3-6 Months
Kerin JF, et al. Hum Reprod. June 2003.
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Micro-Insert Placement Reliance Rates Pivotal
Trial
Second Procedure
Kerin JF, et al. Hum Reprod. June 2003.
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Micro-Insert Wearing Time
0.5
As of November 2003
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Micro-Insert Post-procedure Recovery Prior to
Discharge

• Average time of hysteroscopy 13 minutes
• Average time to discharge 45 minutes
• Most frequent events reported
• Cramping
• Pain
• Nausea
• No post-procedure analgesia required 75

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Micro-Insert Adverse Events Related to
Hysteroscopic Placement
Essure PMA Submission. October 2002.
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Micro-Insert Safety of Placement Procedure

• Adverse events reported in 3 of women
• All resolved prior to discharge
• None required major surgery
• One hospitalization due to pain medication
  reaction
• Micro-insert perforation rate of 1
• No symptoms among perforation patients
• Mild to no pain reported in majority of women

Essure PMA Submission. October 2002.
35
Micro-Insert Days of Work Missed for Employed
Women
74
Does not include day of procedure
of Employed Women
18
5
2
1
3 Days
lt 1 Day
1 Day
2 Days
gt 4 Days
Essure PMA Submission. October 2002.
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Micro-Insert Adverse Event Methodology

• Adverse event any deviation from baseline
• Daily diaries maintained by patients for 6 months
• Investigators prompted by case report form
  questions at each study visit
• Multiple episodes of the same complaint from the
  same woman counted as multiple adverse events

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Micro-Insert Pelvic Pain

• Dysmenorrhea, dyspareunia, ovulatory pain, other
  pelvic pain
• 3 reported pain at more than one study visit
• 1 reported pain at every study visit

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Micro-Insert Menstrual Dysfunction

• Menstrual dysfunction
• Irregular menses
• Spotting or intermenstrual bleeding
• Change in menstrual flow
• Some reported transient changes
• Few reported persistent changes

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Micro-Insert Effectiveness Results (2003)
0.5
Adj. Using indirect method, adjusted to CREST
study population based on 3 age groups
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Micro-Insert Effectiveness
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Micro-Insert Clinical Trial Conclusions
No requirement for general anesthesia or incisions
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Micro-Insert Post-ProcedurePatient Counseling

• Alternative contraception for 3 months until
  follow-up appointment
• 3 month follow-up appointment with HSG
• If any future intrauterine procedure, notify
  provider in advance
• Call Conceptus with questions or concerns

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Other Transcervical Sterilization Methods in
Development

• Quinacrine
• Erythromycin
• Intratubal Ligation Device (ILD)
• Adiana

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Quinacrine

• One of the most widely studied chemicals for
  female non-surgical sterilization
• The method involves
• Transcervical insertion of 2 doses of 250 mg of
  quinacrine pellets using an IUD introducer
• Placed in 2 procedures, 1 month apart between
  days 7 and 10 of menstrual cycle
• Carcinogenic?

45
Quinacrine Study
Long-Term Interim 5-Year Pregnancy Rates (Vietnam)
0.5
46
Erythromycin

• Antibiotic intended to create scar tissue
  permanently occluding fallopian tubes
• May be more effective than Quinacrine
• Formulation issues in the research domain

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Intratubal Ligation Device (ILD)

• Catheter, balloon, and O-ring used to create a
  sphincter, causing occlusion

• Scar tissue causes permanent occlusion

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Adiana

• Catheter inserted into fallopian tube
• Creates superficial lesion
• Porous non-biodegradable implant inserted
• Currently in clinical trials

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Patient CounselingContraceptive Options

• Methods appropriate for the patient
• Side effects
• Failure rates
• Recovery
• Methods not appropriate should be explained

Pollack AE, Soderstrom RM. Fertility Control.
1994.
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Counseling Patients about Permanent Options

• Explain the following to the patient
• Surgical procedureincisional vs. non-incisional
• Preoperative instructions
• The surgical site or transcervical delivery
• Timing of the procedure
• Type of anesthesia
• Length of recovery
• Follow-up tests

Pollack AE, Soderstrom RM. Fertility Control.
1994.
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Patient CounselingMedical Benefits and Risks

• General surgical risks
• Risk of failure to complete the procedure with
  the chosen technique
• The possibility of unrelated changes in
  menstruation due to age or to change in
  contraceptive method

Pollack AE, Soderstrom RM. Fertility Control.
1994.
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Patient CounselingPost-sterilization Regret

• Sterilization should be regarded as permanent.

Curtis KM, Mohllajee AP, Peterson HB.
Contraception. 2006. Moseman CP, Propst AM, Bates
GW, Robinson RD. Obstetrics and Gynecology. 2003.
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Permanent Options for Women Summary

• Sterilization is the most widely used form of
  contraception in the US
• Introduction of new contraceptive methods,
  including permanent options, will help decrease
  rates of unintended pregnancy

more
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Permanent Options for Women Summary (Continued)

• Micro-insert tubular occlusion method is safe and
  effective
• Patient counseling about permanence of
  sterilization is essential because of potential
  for patient regret