Maria Rodriguez and her husband Rolando Oliva decided their family of five was complete after the birth of her third son in November 2022.
She chose to have a surgery at Jackson Memorial Hospital to remove her fallopian tubes to prevent future pregnancies.
“My baby was two months old,” Rodriguez told the NBC6 Investigators. “The same day I went into surgery, he turned two months.”
It was supposed to be a simple outpatient procedure. Rodriguez says her doctor told her it would last up to 30 minutes with minimal risk of complications.
“It will be an in-and-out thing,” she said she was told. “You’ll be home the same night. Back with the baby.”
Instead, she says, she almost lost her life and ended up hospitalized for months. And the active life she enjoyed as a busy working mom was changed forever.
“Unfortunately, because of defective equipment that was supplied to the hospital, this procedure turned into a disaster and a nightmare for this poor family,” said Andrew Yaffa, the attorney representing Rodriguez.
In a lawsuit, Yaffa says the problems began with a piece of equipment called a trocar, which is described as a pen-shaped instrument used in minimally invasive laparoscopic surgery. In Rodriguez’s case, it was used to access her abdomen and guide doctors through the procedure.
“Well, it broke and it fragmented, and pieces were lost inside of her,” Yaffa explained.
Then, he says, it happened again.
“And when they went to try and do the procedure with a second trocar, the second trocar, manufactured by the same company and the same lot, also broke. So Maria now had two sets of fragments floating within her body,” he said.
Yaffa says the 30-minute procedure turned into 10 hours. During that time, doctors opened Rodriguez’s wounds to look for the plastic pieces inside her belly.
The suit filed against the trocar’s manufacturer, Applied Medical Resources Corporation, and Jackson Health System, among others, claims doctors used X-ray, ultrasound and CT scans but were unable to find the plastic pieces. It goes on to say at least one surgeon advised doctors to “fully inspect Ms. Rodriguez’s bowel” to make sure it wasn’t punctured in the process, before closing her up. But “this was never done.”
“The feces, if you will, which is never supposed to be outside of the intestines, were leaked into the belly, and she became systemically infected. And unfortunately, it became a fight for her life at that point,” Yaffa said.
The lawsuit claims Rodriguez was in critical condition and endured surgery after surgery due to the infection and other complications, including a stroke, psychological disturbances, blood clots, blurred vision, and ultimately the forced amputation of several fingers on her right hand.
“And as a woman, when you look down, you’re reminded every day,” Rodriguez said. “My dominant hand is the right one, losing three digits. I can’t open anything. I can’t feed my kids right.”
Rodriguez says the surgeries left her so fragile, she is unable to do the simplest tasks, like driving or even picking up her children.
“It’s torture when you are limited in carrying your kid,” she said. “Because you can’t. Because you could get hurt.”
“She’s always been a really strong woman and now she’s very weak,” her husband Rolando Oliva said. “Mentally, she’s beat up and it’s tough.”
The couple believes it could all have been prevented.
“No question. This company knew that their products were breaking,” Yaffa said.
Since 2015, NBC6 Investigators found over a dozen reports to the FDA of reports of problems involving the device that broke inside Rodriguez. In each of those cases, it either cracked, bent or broke.
“These doctors are not being told that these plastic trocars are prone to breaking,” Yaffa said.
We reached out to the manufacturer Applied Medical. In a statement, they wrote: “Applied Medical is sympathetic to the events alleged by Mrs. Rodriguez’s attorneys in her Complaint. As a healthcare company, we take Mrs. Rodriguez’s claims and any reports of adverse patient outcomes seriously. Applied Medical produces millions of trocars every year and follows stringent manufacturing practices. We have always been known for high-quality devices and are thoroughly investigating this matter.”
When asked about the lawsuit, a representative for Jackson Health System told NBC6 they do not comment on pending litigation.
“It’s unfair, it’s wrong,” Oliva said. “Especially, I would never think that that will happen here in this country.”
Rodriguez just wishes she had known the risks beforehand.
“When we go in, you know, and we put our lives in people’s hands, we expect the truth, you know, honesty,” she said.
Rodriguez says the plastic pieces from the broken devices have still not been found or removed from her body.
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Source: nbcmiami
