A major manufacturer of Filshie clips, which is a method of permanent female sterilization, describes the medical device on its website as follows: “The Filshie Clip is manufactured from titanium and is lined on the inner surface with silicone rubber (both materials are implantable grade). At one end there is a hinge and at the other a latch. The Filshie Clip is applied across the entire diameter of the isthmic segment of the Fallopian tube. When the Clip is fully closed by the Filshie Clip applicator, the upper jaw is flattened and is securely latched under the front end of the lower jaw. This acts as a clasp, securing the upper jaw of the Clip. The silicone rubber is in direct contact with the tissues and both are compressed under the force applied by the titanium.”
“When avascular necrosis of the Fallopian tube occurs, the compressed silicone expands to maintain complete occlusion of the lumen. This prevents re-canalization and destroys approximately 4mm of the Fallopian tube. The dimensions of a closed Filshie Clip are approximately 14mm x 3.5mm x 4mm.”
The same manufacturer of Filshie clips reports in its Instructions For Use “[t]hree instances of apparently asymptomatic migration of the clip were observed as incidental findings, but the frequency of this event is not known.”
While the manufacturer was apparently unaware of the frequency of migration of implanted Filshie clips, our recent experience has been an increasing number of inquiries from women throughout the United States who have Filshie clips who state that they were not told about the possibility that their Filshie clips may migrate (that is, move from its original implantation position) and cause them significant harm, including but not limited to severe pain and/or injury to other organs. Some of these women who experience Filshie clip migration require further surgery to remove the migrated Filshie clip and/or surgical repair of injuries caused by the migrated Filshie clip.
The manufacturer of Filshie clips also warned that “[a]lthough no adverse toxic or tumorigenic effects due to the device or its materials have been reported, the effects of long term implantation are unknown.” Source
From the inquiries we have been receiving from women who have Filshie clips, it may be that the effects of long term implantation may now be becoming known for some women who had their Filshie clips implanted years ago and now have significant pain, discomfort, and other symptoms and/or injuries that may be associated with their Filshie clips.
The FDA’s MAUDE Database
The FDA’s 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.
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.
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 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 who may assist you with your Filshie clip claim.
Turn to us when you don’t know where to turn.