This case involves a female patient who presented to the defending physician with complaints of heavy and painful periods. The patient returned for an endometrial ablation procedure to alleviate these symptoms, using a device manufactured by the defendant. A representative for the defendant manufacturer was present for the procedure, as the surgery center did not own the equipment that was being used. Before the procedure began, the device did not pass a basic operational test conducted by the physician, and failed several subsequent attempts at the same test. Several adjustments were recommended by the manufacturer’s representative, however the device still did not pass the test. The manufacturer’s representative then brought out a new device which passed the test immediately. The procedure was started, however a new error occurred only seconds into the procedure. The doctor corrected the issue, then restarted the procedure. The doctor stopped the ablation again, because he did not like the sound that the machine was making. The manufacturer’s representative agreed that she had not heard that sound before. The doctor removed the device and the patient went to the recovery room.

The next day, the patient reported worsening pain that did not respond to medication. The doctor instructed her to go to the ER. The patient had free air on her x-ray and had a surgical abdomen, and was taken to the OR for an exploratory laparotomy. The patient had a uterine perforation followed by a small bowel perforation secondary to the uterine ablation procedure. The injuries were consistent with a thermal injury, and the patient required several additional surgeries to treat her injuries.

I am highly qualified to work as an expert on this case. I have reviewed many similar devices to the one used in this case, both while at the FDA and during my current forensic work. Additionally, prior to joining the FDA and while working at NASA, I actually reviewed a heat transfer analysis performed by a colleague for the exact same device used in the procedure for this case (uterine ablation device). The fact that device #1 failed the 'air test' (even on repeated tries) indicates it was defective. The fact that device #2 was first tested by the rep (and passed) then handed to the physician to use is suspicious to me. This pass requirement (test before using on patient) is usually called out in the device label. A careful review of the device label is necessary to determine that procedures were followed correctly. I am able to review more records, or the device itself, to determine if it malfunctioned. Additionally, there are many reasons the device could have malfunctioned. On first glance, I question the training of the physician to use this particular device - did the physician receive any training or was he/she relying on the representative? If the physician was properly trained to use the device, based upon the physician's and representative’s descriptions of 'unusual sounds' it does indicate a malfunction in device #2. I have done expert witness work on a large number of cases involving medical devices. I have also reviewed similar cases involving transvaginal mesh, hip implants, kidney stone retrieval device, and infusion pumps. Typically there is a combination of issues that lead to the incident, including device manufacturing problem (quality related), the label on the device not being adequate, and the training/experience of the user/physician for the specific device in question. This case is right in my area of expertise and I am happy to assist.

1. Please discuss your background and experience working with devices as described in the case summary. 2. Was this device more likely than not defective? 3. The doctor testified that he acted appropriately and stopped the procedure when he heard the unusual sound. The MAUDE database is populated with similar events, but no indication of the actual defect. If this is not due to operator error, as the doctor believes, and seems to be borne out by reports of similar events, what potentially happened with the device that caused it to malfunction? 4. Have you ever served as an expert witness on a case similar to the one described above? If so, please explain. 5. Please tell us why you’re qualified to serve as an expert reviewer of this case.

Location: Connecticut B.S., Mechanical Engineering, University of Connecticut M.S., Mechanical Engineering, Stanford University Ph.D., Biomedical Engineering, University of Virginia Fellowship, NASA Fellowship, Food and Drug Administration Member, American Society for Testing and Materials Member, American Society of Biomechanics Member, American Society of Mechanical Engineers Member, Regulatory Affairs Professionals Member, National Academy of Forensic Engineers Former S***** C***************** D****** a* B******** C********* G**** Former E******* N*** A*** R******* C***** Former L*** M****** D***** R******* F*** a** D*** A************* Present, Owner/CEO Medical Device Consultant, engineering consultancy

This exceptionally qualified medical device expert has over 25 years of experience as a practicing engineer. She worked for many years as a Senior Consultant in Medical Devices at an independent practice, as a Lead Medical Device Reviewer at the FDA, and as an Engineer with NASA Ames Research Center, before becoming the Owner/CEO of a medical device consultancy. She has developed her own courses as a faculty member of various major universities. In addition to Class II, III and Combination products, her expertise includes hip implant design/modeling, hemolysis in medical devices, measurement/modeling of epidermal water loss, and biomechanics of human activity. This expert is a member of the American Society for Testing and Materials, American Society of Biomechanics, American Society of Mechanical Engineers, and Regulatory Affairs Professionals. She earned her MS in Mechanical Engineering at Stanford University and her PhD in Biomedical Engineering at the University of Virginia.

Defective Medical Device Injures Patient

A patient encouraged by her gynecologist to use Essure contraception and endometrial ablation filed a medical malpractice lawsuit after she experienced a premature birth. She initially went to her gynecologist after suffering from abnormal bleeding, which caused the doctor to recommend using permanent contraception and the reduction of her uterine lining. The contraceptive was clearly ineffective, however, as the patient became pregnant while transitioning to her Essure device and underwent a highly premature birth. During the consequent trial, an expert in the correlation of ablation to whether a placenta is abnormal or normal was sought out.

There is absolutely a correlation between prior ablation and placentation. I have written and spoken extensively about placentation and placental development, and would be able to review the details and findings of the case to conclude on factors that affected the placental condition.

1. Is there a correlation between ablation and placental findings? 2. Have you ever published or lectured on this subject or issue?

Pathology Expert Discusses Essure Device Ramifications

A gynecologist was sued for failing to observe standards of care after one of her patients developed severe complications from a combination of endometrial ablation and Essure device use. The patient had a past medical history of coagulopathy; her blood was unable form clots, and so her menstruation periods had become increasingly dangerous and painful. As her condition became more severe, she was advised to undergo an endometrial ablation to reduce her uterine lining and use an Essure device to block her Fallopian tubes. However, the procedure resulted in a severe allergic reaction to nickel in the device and other complications from the ablation. The opinion of another gynecologist was needed to assess the procedures and the correct standard of care due to the patient.

As a practicing gynecologist, I have published on, lectured about, and routinely treated patients like the individual described in the case. The resulting conditions of the case can be typical with these procedures, and I would need more information to opine on the standard of care.

1. Briefly expound on your professional experience with the scenario of this case.

Endometrial Ablation Procedure Marred by Essure Malfunction

This lawsuit concerns an endometrial ablation to reduce a woman’s uterine lining, which resulted in damage to her urinary system. The patient’s gynecologist had done the operation in her office, and during her recovery from the procedure the patient developed a vesicogvaginal fistula, an abnormal tract from her bladder causing that caused urine to leak into her vaginal vault. Before the tract could be repaired, the woman had to be catheterized for three months, which she claimed had extensive mental and physical health ramifications. A gynecologist who frequently performed endometrial ablations was needed to assess the patient’s malpractice claim.

I don't perform ablations in the office. Tears are from traction on the cervix or inadequate grasping or poor tissue. The fistula tract could be from a thermal injury from the ablation or trauma from cervical tearing and or repair of the cervix. Handling the tissue carefully is the best precaution a practitioner can take.

1.How often do you perform endometrial ablation in your office? 2. What precautions are taken to avoid cervical tears or vesicovaginal fistulas?

Patient’s Uterine Tract Damaged in Endometrial Ablation

After a patient sustained a perforated bowel from an endometrial ablation procedure, she claimed her gynecologist had failed to observe the proper standard of care. Though the gynecologist claimed that the procedure was successful, the patient began vomiting less than a day after it was completed, and needed to be taken to the ER. A scan revealed that her uterine wall had been punctured, and she had to have an emergency procedure performed to remedy it. The complications continued, however; the patient developed a fistula in post-operative recovery and needed to be hospitalized for four months. Allegedly, her gynecologist had performed the ablation negligently, and an expert in the procedure was needed to comment on the case and assess the necessary standards of care.

As a practicing OBGYN and the Associate Director Division of Gynecologic Oncology at a university affiliated hospital, I have extensive experience performing endometrial ablation procedures. I am very experienced with laparoscopic inpatient and outpatient surgery. This is a very uncommon injury. It should not happen if adequate precautions are taken.

1. Do you have extensive experience performing endometrial ablation procedures? 2. How experienced are you performing laparoscopic outpatient surgery?

Patient Faces Months-Long Recovery from Endometrial Ablation

An endometrial ablation procedure left a middle-aged woman with severe renal complications, causing her to litigate against her gynecologist. After undergoing the endometrial ablation, the woman began to complain of spotting and chronic pain, which further investigation revealed to be scarring around the uterus and adenomyosis, or the growth of endometrial tissue into the uterine wall. A total laparoscopic hysterectomy was recommended, after which the woman suffered pelvic pain and multiple UTIs until a scan revealed that she has experiencing excess fluid in her kidney and severe left renal atrophy. When the doctor’s actions were brought to trial, an expert was needed to review records and opine on the standard of care.

I am a board-certified OB/GYN at an academic medical center with almost ten years of experience in a busy OB/GYN academic practice. I perform 30-40 laparoscopic hysterectomies per year. Routine cystoscopy at the conclusion of a laparoscopic hysterectomy is one way to avoid urinary tract injuries, and identify them early if they occur. It is unlikely that a genitourinary tract injury would happen outside of surgery, but it is possible. Trauma, sexual intercourse, pelvic mass, scar tissue from surgery, delayed changes related to surgery and forced sexual intercourse are other unlikely ways for genitourinary tract injuries to occur. In addition, talking with the patient and physician would help to figure out if the injury was related to the surgery.

1. How often do you perform laparoscopic hysterectomies? 2. What are the safeguards available to prevent genitourinary complications post hysterectomy? 3. Can genitourinary complications be a result of something other than the surgery? 4. How can you determine if the physician caused a ureteral injury or a similar type of injury?

Endometrial Ablation Expert Witnesses

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Endometrial Ablation Expert Witness Case Studies

Defective Medical Device Injures Patient

Pathology Expert Discusses Essure Device Ramifications

Endometrial Ablation Procedure Marred by Essure Malfunction

Patient’s Uterine Tract Damaged in Endometrial Ablation

Patient Faces Months-Long Recovery from Endometrial Ablation

Experts in Endometrial Ablations Opine on Surgery Consequences

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