1) The FDA developed its labeling guidance based on its examination of an increasing number of reported adverse events associated with the system's use (such as persistent pain, perforation of the uterus
and/or fallopian tubes, intra-abdominal or pelvic device migration, abnormal or irregular bleeding, and allergy or hypersensitivity reactions) and its evaluation of a trade complaint regarding allegations initially made in a Citizen Petition.
These may include persistent pain, perforation of the uterus
or fallopian tubes from device migration, abnormal bleeding and allergy or hypersensitivity reactions.
Although perforation of the uterus
by an IUD is rare, migration to the appendix is extremely rare.
DISCUSSION: Perforation of the uterus
by an IUCD was first described in 1930 by Murphy and Andrews independently.
Common abortion complications are infection, excessive bleeding, embolism, ripping or perforation of the uterus
, convulsions, anesthesia complications, hemorrhage, cervical injury, endotoxic shock and sterility.
Apart from the risk of breast cancer following abortion, there is also an increased risk of cancer of the rectum, ovary and uterine cervix; perforation of the uterus
and placenta previa in subsequent pregnancies; premature delivery, with consequent 38 times increase in cerebral palsy and cognitive impairment of a subsequently conceived infant; six times lower fertility; emotional difficulties, and three times the risk of suicide, as well as five times the risk of substance abuse.
A preliminary diagnosis of complete perforation of the uterus
with the IUCD lying adjacent to the serosal surface of the uterus was made.
They are quick to perform and the recovery period is short, but there may be a small risk of perforation of the uterus
and of bowel injury.
IUDs have been implicated in cases of perforation of the uterus
, septic abortion, pelvic inflammatory disease and ectopic pregnancy.
On the subject of safety, the guidance stated: 'The evidence highlighted a number of complications that occurred, including perforation of the uterus
, minor secondary haemorrhage and burning of the vagina, cervix and small bowel.
Other side effects can include perforation of the uterus
, abnormal bleeding, and cramps.
PHYSICIAN'S DEFENSE The infection that developed came solely from the perforation of the uterus
, a known complication of hysteroscopy.