Mesh Medical Device News Desk, May 22, 2016 ~ The U.S. Food and Drug Administration (FDA) has put safety in the back seat in approving several high risk devices for obstetric and gynecological procedures, according to a study by researchers at Northwestern University.
Citing the problems with transvaginal mesh, power morcellators, and the Essure birth control device, researchers reviewed the 18 medical devices approved by the obstetrics and gynecology advisory committees of the FDA between January 2000 and December 2015.
Focusing on the devices with the highest potential risk to patients, they found many made it to market based on flawed data from studies that were either too small or too short. They conclude they should have undergone more rigorous pre-approval and post-approval scrutiny.
Devices include those for Endometrial Ablation (33%), where menstrual flow is reduced; contraception (28%), such as Essure, a permanent sterilization device was approved after short-term evidence and insufficient post-market follow-up; and 17% were for fetal monitoring.
“Transvaginal meshes and laparoscopic morcellators are two devices cleared through the less stringent 510(k) pathway of the FDA which requires little to no additional clinical evidence or postmarketing surveillance before clearance. Although it is impossible to know retrospectively whether more rigorous regulation would have prevented complications associated with both devices, it may have provided earlier warning of patient safety risks.”
The information comes at a time the 21st Century Cures Act is under consideration by the Senate after passing the U.S. House of Representatives this month. It contains provision that would further reduce medical device regulation by widening what is considered “valid scientific evidence.”
Dalkon Shield was approved in the 1970’s had a string that was a pathway for bacteria leading to infertility and infection, septic abortions and death. The dangerous device was the basis of passage of the 1976 Medical Device Amendment which granted the FDA authority to regulate medical devices.
Unlike drugs, the approval process for the majority of medical devices, even those permanently implanted, do not require clinical trials, randomized controlled trials or even post-market surveillance.
Meanwhile, drugs must undergo premarket approval which includes clinical trials involving humans.
THE FDA DEVICE REVIEW
Since approval of the 18 devices, the Northwestern researchers found three have been withdrawn from the market, two of which had failed to show efficacy in their clinical trials (fetal monitors, noninvasive). One was not required to be monitored after approval and removed from market because of patient safety concerns.
During this review, one-third of the 18 devices were not required to undergo postmarket review or studies. Of the devices, 42% were approved based on nonrandomized controlled trials ranging from three to 48 months.
Four devices were approved even though they failed to demonstrate efficacy in clinical trials.
The advisory committee recommended 9 devices for approval and recommended three devices not be approved. The committee recommended against approval of both the Stan S31 Fetal Heart Monitor and the LUMA Cervical Imaging system.
The median approval time was 290 days from application to market.
Intergel, made by Gynecare Worldwide (J&J), was an adhesion prevention gel solution put in an open abdominal cavity to keep tissues from sticking together during the healing process. After two years on the market, Gynecare Intergel was withdrawn April 16, 2003 here due to reports of serious foreign body reactions and postprocedure pain.
The committee recommended against approval of Intergel which did not demonstrate significant differences compared with its control. During its review, Intergel required no additional postmarketing studies outside of adverse event reporting.
Essure, a permanent birth control device, is currently undergoing increased regulatory scrutiny as a result of complications reported to the Manufacturer and User Facility Device Experience database (MAUDE).
Essure’s approval was based on a prospective single arm study with a primary outcome of pregnancy at one year. It was approved through the premarket approval pathway “with insufficient long-term evidence and postmarket surveillance requirements” say researchers.
The researchers conclude there are “significant weaknesses” in the preapproval and post approval regulation of high-risk obstetrics and gynecology devices. They recommend more rigorous clinical studies before and after devices make it to market.
“The important question to ask is: should we really be holding high-risk medical devices to a lower standard of evidence than drugs?” says Dr. Steve Xu the lead researcher.
The study is published in the journal Obstetrics and Gynecology, May 4, 2016, here.
While industry argues that more regulation will slow innovation, the researchers say there is limited evidence to support that assertion.