A married woman in Baltimore who had previously given birth to three healthy children discussed and agreed with her OB after the birth of her last child in 2015 that the OB would perform a sterilization procedure on her so that she would not get pregnant again. The woman’s decision was based on the severe financial strain that having a fourth child would have on her family.
The sterilization procedure was scheduled for several months after she gave birth to her third child. The OB agreed to perform the procedure that would be done at the hospital. The procedure was described in an informed consent document signed by the woman two months before the procedure as “tubal sterilization” and also as “tubal ligation.” After the simple procedure was completed, the OB told the woman that the sterilization procedure that she had performed was successful and that the woman was now unable to become pregnant again.
The OB selected the type of sterilization procedure that she intended to perform on the woman and wrote in pre-procedure records that she would be using Filshie Clips for the sterilization procedure. Filshie Clips are hinged clips made from titanium that are lined with silastic rubber. They are less than one-half inch long and about one-eighth inch wide when closed. Filshie Clips are placed on each Fallopian tube using a special applicator. They work by compressing the Fallopian tubes and thereby preventing eggs from traveling from the ovaries to the uterus. Source According to Dr. Filshie himself, the overall failure rate of Filshie clips is 2.7 per 1,000 patients during their lifetime (lifetime risk, not annual risk). Source
An OB resident dictated the Operative Note for the woman’s sterilization procedure in which the resident implied that she (the resident) had performed the sterilization procedure on the woman, with the OB in the operating room and supervising the resident during the entire procedure. The Operative Note described the procedure as a laparoscopic tubal ligation employing Falope-ring to achieve sterilization. Falope-ring is a technique different from – and distinct from – Flishie Clips. A Falope ring is a small silastic ring-shaped band that is placed around a 2 to 3 cm loop of a Fallopian tube that is drawn inside an applicator. The Falope ring that is stretched over the outside of the applicator is released onto the loop of the Fallopian tube, thereby blocking the Fallopian tube (the loop of the Fallopian tube that is constricted is deprived of blood flow and is thereafter replaced with scar tissue). Source
The Operative Note dictated by the OB resident within hours after the sterilization procedure, and signed by the OB four days later, describes in detail how the Falope-Ring applicator was used, how the loop of Fallopian tube was drawn into the applicator, how the Falope ring was applied, how the loop of Fallopian tube blanched as a result of the interrupted blood supply to the loop, and how the Falope-ring procedure was repeated on the other side. The OB’s subsequent office notes state that Flishie Clips were used during the sterilization procedure and do not mention Falope ring at all.
Despite the intention of the OB and the woman that the sterilization procedure result in permanent sterilization, the woman subsequently found out that she became pregnant after the procedure. The OB provided the woman with a pill to induce an abortion, which was a difficult decision for the woman. Astonishingly, the OB took no steps to determine why the woman became pregnant at that time (including testing to determine if one or both of the woman’s Fallopian tubes were blocked), and the OB failed to discuss with the woman that she should use other methods for contraception or advise her that she could become pregnant again.
Weeks after terminating the unwanted pregnancy following the unsuccessful sterilization procedure, the woman found out that she was pregnant again (i.e., her second pregnancy after her sterilization procedure). The woman had to undergo a second, emotionally-charged abortion. The woman’s primary care physician then ordered a simple, noninvasive imaging test that determined that one of the woman’s Fallopian tubes was not blocked, and that determined that Filshie Clips and not Falope-rings were used during the sterilization procedure.
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