I write in connection to the September 24, 2009 announcement by the Food and Drug Administration (FDA) that the agency is considering reversing clearance granted of a knee-surgery device, after finding evidence that the agency under then-Commission Eric von Eschenbach may have been swayed by political pressure to clear a product for marketing. It had previously been rejected repeatedly by FDA staff scientists for safety concerns. The story was reported in The Washington Post September 25th.
Until more teeth can be put into the process of approval by the FDA to fully vet devices that are implanted in the body so that more safety data is required before clearance for marketing is granted by the Government, patients need to undergo a more rigorous informed consent experience. There must be more extensive public education of patients prior to such surgery so they fully understand their alternatives and the risks and potential benefits associated with each. An example is the unbranded coverage of implants for both SUI and prolapse in women and SUI in men, found at www.nafc.org Discussions prior to surgery should take place with their surgeon, not an administrator or staff nurse who reads aloud a text dense document in rapid fire fashion. No patient should be taken into the OR without a separate surgical consult. Individuals also need to be informed about economic considerations, regardless of whether the procedure is fully insured through private or public payment mechanisms. Patients need to be informed of any and all financial incentives their doctors and surgery centers may have for performing some procedures over others. Full disclosure is a must.
Patients should be given adequate time to reflect on all of these considerations, with several days rather than a few hours or less for reflection, additional questions to be answered, and even dialogue with others. Informed consent involving the implantation of a new device with limited data should include an objective witness, verifying such guidelines have been duly followed and certifying that the patient is capable of digesting all that has been revealed for decision-making.
Just as we've seen in recent cases settled in court involving patient deaths related to undisclosed information by pharmaceutical companies about risks of drug usage, post-market surveillance by the FDA of all drugs and devices is growing in importance. Voluntary online postings by doctors in the MAUDE database reporting adverse events involving 510K devices are insufficient. There should be random audits of company and surgery center OR and outcomes data. Consumers should have ease of access to this information as well, without having to file a request through costly attorneys under the Freedom of Information Act. Lastly, all implanted devices should be barcoded and tracked by the facility where they were implanted so we have a prayer of readily finding patients should recall be needed by responsible manufacturers.
Why can't we begin working as an integrated team in the healthcare delivery system here in the U.S.? Why do companies and agency administrators ever have a chance to outsmart the system? Why do dishonesty, corruption, and laziness prevail when patient lives are at stake?
National Association For Continence
Published On: October 15, 2009