The report by Harrison et al clinically informs the developmental events of Pfizer’s Björk-Shiley convexo-concave (BSCC) valve to date. I would like to present the other side of the story from a recipient of a BSCC mechanical valve. Apparently, there are still over circa 7,000 patients worldwide—like myself (29MBRC40537 Mitral 31-03-83)—wearing this controversial implant. The several implantees I know suffer from a never-ending anxiety of living with a mechanical prosthetic valve with questionable structural integrity, knowing the medical consequences of valve collapse. Regrettably, neither the Panel nor Pfizer have adequately addressed this daily concern of the surviving BSCC patients.

A reader may respond “… if a patient is that worried, then just change the valve.” In reality, it is not like booking a Learjet for a company Christmas party. Making the decision to undergo elective prophylactic open heart surgery is extremely difficult and psychologically draining. An implantee would agree to explant, “not due to wear and tear of the valve,” but premature explantation could expose the patient to the risk of endless morbidity complications postoperatively.

The report comments “unfortunately, occasional unexpected adverse events have and will continue to occur.” They brush over the human cost of living with a suspect BSCC valve. Pfizer was entrusted to engineer a prosthesis at the very cutting edge: a device that opened-closed 100,000 times a day for circa 100 years. The substandard welding, poor quality control, falsification of production records, and valves shipped misaligned are all well documented.

Figure 2 of the report by Harrison et al is crucial to appreciate the significance of this medical event. A statistically significant number of structurally incompetent valves fractured early, then there was a progressive decrease as other substandard valves fractured through the next 2 decades. An unknown number of valves were outside an acceptable safety envelope: operating too close to the border between functioning and collapse. Logic infers there may be more fractures, as the Panel warns.

Unfortunately, most valves electively explanted under the Supervisory Panel’s valve replacement guidelines (Harrison et al ) have been intact (92% in one study 3) while patients who were considered to be at low risk have suffered fatal strut fracture. Blot et al estimated circa 6.8% of implantees have a single leg separation, that is, circa 500 implantees with a substantially elevated risk of valve collapse. It is generally accepted that the continued search for a diagnostic device for detection of a single leg separation is of paramount importance to save lives and keep the BSCC patients and their physicians informed of the status of their valve cohort with the passage of time. Currently, the Panel is funding a preliminary BSCC imaging project (using x-ray computed tomography) at a United States medical facility to assess the accuracy (specificity and sensitivity) in diagnostic analysis of a set of BSCC valves in a double-blind test. BSCC patients await word of the results from the Panel.

After several years, Pfizer withdrew all the BSCC valves from the global market in 1986: the gathering litigious storm reminded Pfizer that patient safety was paramount. It is not just the hundreds of patients who became a statistic (Figure 2 of the report by Harrison et al ) plus the thousands of family members whose lives were negatively impacted forever but the thousands of class members, and implantees worldwide, who still walk Pfizer’s tightrope, have done so for decades and will continue to. Pfizer presided over what is arguably the greatest catastrophe in cardiac valve prosthetic history.

Harrison et al comment in their report that “very careful monitoring of new devices is now recognized to be an essential component …” Well, BSCC patients had a reasonable expectation that exceptional quality control and production also were expected 30 years ago. The point is that negligence and incompetent management prevailed in the manufacturing of the BSCC valves.

Pfizer had a duty of patient care toward all 86,000 implantees. My valve was implanted on March 31, 1983; at that time Pfizer knew of numerous fractured valves, and an almost exponential increase in fracture rate was occurring (Figure 2 of the report by Harrison et al). An exponential increase in device malfunction is symptomatic of a major design or production flaw or both. And yet the manufacturer allowed a structurally questionable valve to be implanted, along with thousands of more trusting patients, for another 3 years.

The investigators’ style reflects the role they assumed in the settlement; however, no airtime is allocated to the human impact to thousands of patients living day by day with psychological and chronic stress. How many are suffering in silence? We may probably never know because United States privacy laws prevent contact details of patients from being released.

As a scientist and BSCC patient, I take a slightly more eyes-wide-open approach to the possible fractures in the future, with clear evidence of substandard welding, tampering of valve production records, design weaknesses and/or microcracks, and structural fatigue.

The Panel mentions one purpose of publication is to offer hints and tips to similar settlement panels. I would add 2 aspects for future consideration:

• (1)
  

  Representation by medical patients on supervisory panels. Often many qualified and highly experienced patients are not empowered to contribute. Such experience and life skills would enrich the panel by bringing realism to the decision-making process. The silent majority has had a very limited opportunity to have a voice.

  
  
• (2)
  

  Funds should be ring-fenced to permit long-term monitoring of cohorts to detect any future spikes in implant failures, monitor and offer long-term psychological support for an aging patient population, and establish a mechanism which permits patients to contact one another and benefit from group therapy. If we continue to give big pharmaceutical companies sufficient wriggle room to flex its muscles and allow corporate gain to come before patients’ safety, then should not we at least during future settlement negotiations make such significant provision for the long-term support for their patient victims throughout their lifetime?