PHILADELPHIA -- Nine physicians across the country are testing a revolutionary new female sterilization technique that, for the first time, does not require surgery.
Invented by Richard Erb, senior research scientist at the Franklin Institute Research Center of Philadelphia, the technique uses liquid silicon to form a plug at the base of the fallopian tubes.
John Schorsch, director of RSP Laboratories in Stamford, Conn., which is associated with the procedure, stressed that it remains in the testing stage and is only available to volunteers at seven locations in the United States. The Federal Drug Administration is monitoring the clinical tests and is expected to decide whether to approve it within two years, he said.
'The technique involves placing a liquid silicon material into the fallopian tube, which becomes a rubbery solid in three or four minutes,' said Erb. 'A plug is formed in place which is bonded to a little rubber tip in the uterine cavity. You have a custom-formed ovary plug.'
He explained the technique is referred to as sterilization, rather than contraception, because no proven method of reversibility has been found.
'I've been working on it for 11 years,' said Erb. 'Conceptually, it is simple, but it was necessary to design all the instrumentation and components for the device.'
The silicon method differs from common forms of sterilization in that it involves no incision or surgery and can be done in a physician's office with a local anesthesia, said Erb.
Clinical tests began in 1978 and will continue until 1983 with women volunteers who 'have accepted it as permanent sterilization,' said Erb. 'We don't have enough information yet to consider that it is reversible. That will take subsequent volunteer tests on the women and we won't know for several years.'
Some work has been done with rhesus monkeys and rabbits on reversal of the silicon sterilization procedure, said Erb. Of eight rabbits that underwent the procedure and then had the plug removed, two became pregnant on first mating, said Erb.
In the tests done so far, doctors have found 1 or 2 percent of the women suffer side effects of pelvic pain, said Erb. In those cases, the plug was easily removed with a retrievable loop on the soft silicon rubber tip.
'There have been no pregnancies if the plug has been properly formed,' said Erb. 'In the earliest tests, we had two pregnancies with improperly formed plugs through loss of pressure on the silicon while it is forming. Now we maintain pressure until it jells to insure the fallopian tubes stay in the full open position.'
The physicians who are conducting the clinical tests of the silicon sterilization are Dr. Theodore Reed of Lankenau Hospital, Philadelphia; Drs. Michael Baggish and Augusto Chong of Mt. Sinai Hospital, Hartford, Conn.; Dr. Herbert Harris of Long Island Medical College, Brooklyn; Dr. John Marlowe of Washington, D.C.; Drs. Jay Cooper and Franklin Loffer of Phoenix, Ariz.; Dr. John Levinson of Wilmington, Del.; and Dr. Frank Schramm of Bethlehem, Pa.