Christina Potts was trying to find a method for permanent birth control when her physician gave her only one option, Essure. The device prevents sperm from reaching the egg and is placed in the fallopian tubes. The procedure left her fatigued, in terrible pain and led to a hysterectomy. To rid herself of Essure, her uterus and tubes had to be removed. She will never know if Essure was recommended by her former gynecologist because the device suited her needs or if the doctor was paid thousands and thousands of dollars by Bayer.
Concerns regarding safety have been expressed by the US Food and Drug Administration about Essure. An announcement has been made by Bayer Pharmaceuticals that the device will be taken off the market by the time the year ends. An analysis of the data by CNN revealed that between August of 2013 and December of 2017, Bayer paid 11,850 physicians $2.5 million for Essure consulting services and fees. Despite the legality of these payments, they are extremely controversial. The data also revealed one of the biggest earners was Christina Potts physician. Between August of 2013 and the end of 2017, Dr. Cindy Basinski was paid for services and consulting fees in the amount of $168,068.
In excess of eighty percent of the money paid to Indiana physicians by Bayer for Essure was for Dr. Cindy Basinski. She received the second highest payments on a national average and was one of only three physicians earning over $100,000. This information is from a federal database encompassing the period from August 13th until the end of the previous year. She admitted receiving payments pertaining to Essure for five previous years but this is further than the database goes back. She stated she does not remember the amount but believes it was minimal at roughly $5,000 to $7,000 per year. She intends to continue Essure implants until the device is taken off the market.
Scientists at numerous universities including Harvard, Yale, North Carolina and George Washington show when a physician accepts payment from a pharmaceutical company, the chances of them prescribing the drugs manufactured by the company are higher. These studies revealed the average payment is much less than what Dr. Cindy Basinski received. She stated the same amount could have been earned during the time Bayer paid her to educate physicians about implanting the device. Bayer is citing declining sales for the reason the device is being pulled from the market and says the device is safe. The US Food and Drug Administration stated the device has serious risks including perforation of the fallopian tubes and uterus, persistent pain and migration of the coils leading to the abdomen and pelvis.
The announcement made by Bayer was just a few days prior to a documentary on Netflix regarding the dangers of medical devices like Essure. Bayer said the film presented a misleading representation of Essure. The documentary featured a group of women who have spent years lobbying Congress to remove the device from the market. They have a Facebook group called Essure Problems. The group has over 37,000 members. This includes 12,000 women who required a surgical procedure or hysterectomy to have the device removed. Christina Potts was 27 when she spoke to Dr. Cindy Basinski about having her fallopian tubes tied. The physician told her with four small children the recovery time made the procedure the wrong choice. She said she could implant Essure right in her office.
Christina Potts needed a hysterectomy to remove the device. She said she felt like she was pushed into having the procedure and developed fatigue, abdominal cramping, joint pain and headaches roughly a year after the procedure. Her symptoms are nearly gone after the hysterectomy. She is angry her physician dismissed tubal ligation or tying her tubes so easily. She said Dr. Basinski made the decision and gave her no other option. Another patient also said Dr. Basinski dismissed having her tubes tied in favor of Essure. This patient went to another doctor for the procedure she wanted. CNN stated health care professionals are being paid by pharmaceutical companies for their services and expertise. The payments made by Bayer were ethical despite the controversial nature of these types of payments.
CNN was recently provided with a document from Bayer. This outlined the procedures the company used for payments related to Essure for medical experts. The document stated the agreements made between consulting physicians and Bayer are not compensation for using Essure. They further stated these physicians were not receiving payments from Bayer to prescribe, purchase or support Essure in any way. Dr. Martin Makary serves Johns Hopkins Medicine as a patient safety expert and a professor of surgery. He said while it was ethical for physicians to be paid by pharmaceutical companies for genuine research, he did not believe this was the case with the 11,000 physicians Bayer had made payments to. He said it appeared to be a bribe and looked like doctors were being paid off by the pharma company.
The estimate of the FDA is that over 750,000 patients have used Essure all over the world since the approval on November 4th of 2002. During this period, Conceptus Inc. was marketing and manufacturing Essure. This company was acquired by Bayer in June of 2013. During the period beginning in 2002 and ending in 2017, The most common problems reported to the FDA by patients were 21,215 cases of pain or abdominal pain, 9,846 of menstrual irregularities and heavier menses, 7,231 of headaches, 4,970 weight fluctuations and 5,842 of fatigue. The FDA stated the reports of these events is unable to be used or interpreted to reach any conclusions regarding the existence or frequency of problems or any severity associated with the device.
The FDA additionally stated it is difficult to confirm whether or not a specific event was caused by the device solely based on any information provided by a report. The sales of Essure were restricted in April by the FDA. Essure can only be used when the physician has provided the patient with educational materials from the FDA describing the risks of the Essure device.