MAUDE Adverse Event Reports For Filshie Clips

A Filshie clip is a silicone-lined, titanium occlusive device, originally designed for surgical contraception that was approved by the FDA in September 1996 for permanent contraception in women. The Filshie clip is placed with a reusable applicator and designed to permanently occlude the mid-isthmic portion of the fallopian tube segment but also has the potential for occluding vascular structures during laparoscopic surgery.

A major manufacturer of Filshie clips describes the medical device as a “small titanium clip with soft Silastic® lining [that] is an effective and immediate method of surgical sterilization. After the clip is applied, the silicone lining maintains pressure on the tube, resulting in complete tubal occlusion and eventual necrosis at the clip site. The Filshie Tubal Ligation System provides the most versatile and effective tubal ligation for either inpatient or outpatient procedures.”

Despite the wide-spread use of Filshie clips for tubal ligation (sterilization) procedures, many women have experienced unexpected problems sometimes associated wth Filshie clips including unwanted pregnancies, migration of the Filshie clips, severe pain, irregular periods, heavy bleeding with clots, severe menstrual cramps, etc.

A review of MAUDE Adverse Event Reports in the FDA database shows that in June 2018 alone, women have reported the following issues with their Filshie clips:

“I had the filshie clips applied in 2018. Since then i have been suffering from anxiety/depression, burning pain in vagina, frequent urination with no infection and one of the clips had migrated to my upper left abdomen. I have had chronic abdominal and back pain for the last month, yet the drs are not concerned with the clip lodged near my kidney/liver.” Source

“Filshie clip migrated and embedded in colon. Pain began in (b)(6) and i was in and out of hospitals and dr offices with multiple scans of right side. Filshie clip – one has been left inside as the er surgeon only removed the one that broke off.” Source

“Had filshie clip inserted to prevent pregnancy. The inserting doctor told me that she was uncertain if one of the clips clipped into place so she also burned the tubes as well.” Source

There were eight (8) MAUDE Adverse Event Reports for Filshie clips during May 2018, and 307 MAUDE Adverse Event Reports for Filshie clips in the FDA database.

The MAUDE database houses medical device reports submitted to the FDA by mandatory reporters (manufacturers, importers and device user facilities) and voluntary reporters such as health care professionals, patients and consumers.

In Canada, 54 civil actions for failed tubal ligation were initiated from 1999 to 2008 (there were 24,023 tubal ligations performed in Canada in a 12-month period in 2009–2010). Litigation most commonly arises from the inherent failure rate associated with the procedure itself, poor surgical performance, or inadequate preoperative counseling or consent.

Incompletely closed Filshie clips were a factor in a large number of litigation cases brought in Australia in 2000 and arose because of failure of the applicator to close down the clips properly. In one geographic area, 10% of women who had Filshie clip sterilization subsequently became pregnant (40 times the reported failure rate).

Tubal non-occlusion and occlusion of the wrong structure are considered negligent actions (i.e., medical malpractice).

Source

If you or a loved one suffered injury or other harm from the use of Filshie clips in the United States, you should promptly find a medical malpractice lawyer in your state who may investigate your Filshie clip claim for you and represent you in a Filshie clip medical malpractice and/or product liability case, if appropriate.

Visit our website or call us toll-free in the United States at 800-295-3959 to find medical malpractice attorneys in your U.S. state who may assist you with your Filshie clip claim.

Turn to us when you don’t know where to turn.

This entry was posted on Thursday, August 23rd, 2018 at 5:20 am. Both comments and pings are currently closed.

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