TUBAL CLIPS

Faulty female sterilisation is the commonest cause of gynecological malpractice action. The tubal clip most commonly used today has nearly 100% reliability if correctly applied. Negligent cause should generally be assumed until proven otherwise by medical screening.

Failed sterilisation is a frequent source of medical malpractice enquiry - and a successful cause of action in certain circumstances.

Practice Point

Failure of surgical sterilisation is not de facto evidence of substandard operative technique but is generally worth screening medically

Methods for surgical termination of fertility have well-documented and apparently obligatory failure rates. As with other surgical procedures, operative success cannot be guaranteed. In the absence of evidence to the contrary, failure to prevent subsequent pregnancy is generally attributed by the defence to intrinsic imperfections of the method rather than to negligent operator error.

Nevertheless, failed sterilisation litigation almost always requires detailed medical analysis for evidence of faulty technique or deviation from accepted procedures.

Male sterilisation is not considered complete until two consecutive semen specimens are free of moving sperm. Subsequent confirmed paternity is generally attributed to recanalisation (reconnection) of the severed ends of the vas deferens.

Practice Point

If laparoscopic tubal surgery proves technically difficult, either the procedure should be converted to an open technique, or the interruption of the fallopian tube checked postoperatively by dye studies (hysterosalpingography)

Faulty female sterilisation is the commonest cause of gynecological malpractice action. Female sterilisation by surgical interruption of the fallopian tubes can and should be confirmed by diagnostic imaging studies with dye that is opaque to xrays hysterosalpingogram if there is any doubt, for instance after a difficult laparoscopic tubal ligation. However, this test is subject to considerable type 1 (false positive) and type 2 (false negative) error^1a,1b,1c, and should not be relied upon for sole confirmation.

The tubal clip most commonly used today has nearly 100% reliability if correctly applied. Occlusion by tubal clips is now the preferred female technique in many instances, because intentional reversal is technically easier. The Filshie clip is the most popular, and is the source of a steady trickle of actions for medical malpractice.

Practice Point

Incorrect anatomical placement of rings and clips is de facto evidence of substandard technique, and defence arguments of migration should be treated with scepticism

The spring-loaded Filshie clip (Mark VI, developed 1992 and available in North America since 1996) crushes a greater length of the tubal ligation. than other models, and does not cut through the tube. Such inadvertent severing and subsequent dislocation of the device is thought to be the basis of occasional recanalisation after correct application of other types of clip.

Practice Point
Pathological and surgical studies show that most failures result from faulty operator technique

Negligent cause should generally be assumed until proven otherwise by medical screening. Much has been made by defence experts of the occasional reports ^2a^{,
2b, 3,
4} of migration of tubal clips, including complete expulsion through the vagina. However, anatomical pathology studies ^{5
6}have confirmed that correct application of the Filshie clip irreversibly injures the fallopian tube over such a wide area that permanent infertility does not depend on the continued correct location of the clip.

Practice Point

With the current generation of Filshie clip, there is no proven instance of device failure

In general, subsequent radiographic or surgical examination⁷ shows the failed device to have been incorrectly placed - for instance, incompletely over the lumen (channel) of the tube, or on the round ligament or broad ligament that are anatomically adjacent.

Although information is incomplete in some cases, there is no documented instance of a Filshie clip having been ineffective after being correctly sited.