How do patients know if a fertility clinic is reliable? Lack of regulations mean lack of data

CLEVELAND - It was a national story -- a devastating failure at the University Hospitals Fertility Center that put hundreds of families’ futures in question when a storage tank malfunctioned and thousands of eggs and embryos were destroyed.

While failures that catastrophic are rare, a review by News 5 Cleveland uncovered dozens of other cases involving heartbreaking mistakes at fertility centers around the country. 

Our investigation found that the U.S. does not monitor fertility clinics or require clinics to report those tragic errors, making it impossible for patients to find out about problems.

Sierra’s story 
Sierra Mathews, 22, still dreams of becoming a mother someday. 

“It’s very important,” Mathews said. “I want to be able to love my own kids. It's hard right now to think that that's possibly been taken away from me."

Mathews is one of 950 patients whose eggs or embryos were lost during the catastrophic malfunction at UH the weekend of March 3. 

A senior at Bowling Green State University studying early childhood education, Mathews found out about the failure when her parents called her at school. They asked her if she was sitting down, then told her they received a letter from the hospital that all her eggs were likely gone.

“I was just in a state of shock,” she said. “I just remember flashbacks happened of everything that I had to go through.” 

After being diagnosed with ovarian cancer, Mathews underwent fertility treatments at 19 years old to preserve her chances of having a child of her own.

She said the process was difficult.

“I’m afraid of needles, so it was very traumatizing having to stick myself, like three times a day," she said. "I couldn’t even do it -- my dad had to it for me."

She also experienced an allergic reaction to one of the medications used during the treatments. Her face became swollen, and she had difficulty breathing. 

Despite those difficulties, the treatments were successful. 

She thought she had a safety net. 

“I trusted everything would go smoothly,” she said. “But it didn’t, at the end, because all the eggs are gone.”

Inadvertently destroyed 
While massive failures, like the one at UH are “relatively rare”, failures at fertility centers happen “probably more than we think,” said Browne Lewis, a Cleveland State University law professor and expert on reproductive issues. 

“What they [fertility centers] tend to do is report the success stories and not when there are problems,’ she said. 

Because the industry is unregulated -- and it's impossible for patients to find out if any errors have occurred at clinics -- we compiled a list of incidents based on lawsuits and reports involving clinics across the country.

We found 46 tragic incidents dating back to the 1970s. 

A few examples: 

  • In Beverly Hills, a woman’s fertility doctor told her that her embryos were accidentally thrown out
  • In L.A., a woman’s embryo transfer was canceled after doctors discovered her two embryos were missing
  • A Sylvania, Ohio mom was accidentally implanted with another woman’s embryo 
  • A Louisiana man sued a Houston fertility clinic after it gave his sperm to his ex-girlfriend without his permission

Scroll through for more:

 
Keith Whitacre, an embryologist at Northeast Ohio Fertility Center in Akron, said that in his experience, accidents and mistakes are anomalies.
 
"In my 28 years of doing IVF (in vitro fertilization), accidental loss of embryos or accidental destruction is something that's extremely rare,” he said. “I’ve never, at least to my knowledge, disposed of an embryo improperly or discarded an embryo improperly.
 

“What does happen is that IVF is not perfect. Not every one of our patients gets pregnant."

An unregulated industry 
There are virtually no government regulations for fertility centers, which makes it "next to impossible" to find out about past problems, said Cleveland State professor Lewis. Clinics are only required to report success rates from fertility procedures, like the number of babies born, to the Centers for Disease Control. 

Failures remain a mystery. 

“There is really no way for a patient to know what is going on at a fertility clinic,” Lewis said. 

Critical components are self-regulated. For example, no agency inspects storage tanks, like the one involved in UH’s disaster. 

"We should learn that if we're going to continue letting medical technology create different ways to have children, we have to regulate it,” Lewis said.

Strict standard
Whitacre showed News 5 Cleveland the lab where he creates and stores embryos.

“What regulations are we talking about?” Whitacre said. “We already have very strict standards.”  

Eggs, sperm, and embryos are stored in two tanks resembling milk bottles. 

He or his staff check the tanks' temperature daily to make sure the specimens are safely frozen.

They also replenish the liquid nitrogen, which keeps the tanks cold, on a weekly basis. 

In terms of an alarm system, a loud warning is blasted one minute after the lid of the tank is left open. It also triggers a call to Whitacre’s cell phone and a group of other employees so any problem can be immediately addressed before the specimens are put in danger. 

"I wouldn't do anything different or act any differently if there was a law that governed what I do for a living,” he said.

A fragile future
"Even if they are rare, it's still something that is so horrible that happens,” said Mathews about the fertility clinic failures. “It shouldn't even happen at all." 

Unlike many UH fertility patients, Mathews is not sure she will be able to undergo more fertility treatments. 

Doctors already removed her right ovary. They are monitoring a tumor in the other. 

After her final exams at Bowling Green State University this month, she plans to explore her options.

“I love kids,” she said. “So, it means a lot to me to be able to have kids. It's hard right now to think that’s possibly been taken away from me."

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