Who will ascertain quality of an implant – Doctor or the manufacturer?

It is a doctor’s responsibility to check the quality, effectiveness, etc. of an implant before inserting the same. Law is very clear on this aspect. Any complication arising due to defect of such an implant is negligence.

Sudhakar was diagnosed with cataract in both the eyes. He approached Dr. Patel who performed a surgery and inserted Intraocular Lens (IOL). During one of post-surgery follow ups, it was observed that the IOL inserted was opaque.

Another surgery was performed, but by that time patient’s cornea of the left eye was considerably affected.

Sudhakar sued the doctor and alleged negligence on his part.

The doctor in defence stated that ascertaining functional ability and quality of the lens was not possible as only the manufacturer had the equipment to verify the same. Moreover, onus to provide a safe, non-defective and quality lens lies with the manufacturer stated the doctor.

The Commission, citing medical records, observed that the first lens was indeed opaque as the same was recorded in discharge summary.

Dr. Patel may have been relieved hearing the observation, but the reassurance was short lived, as the Commission stated the following:

“The standard protocol is clear – it is the surgeon, who has to verify the quality of lens, which includes power and suitability. The quality of lens includes checking the opaqueness, if any. Therefore, the doctor’s contention that the quality / opaqueness or otherwise can be examined only by the manufacturer alone cannot be sustained”.

“There is contributory negligence on behalf of the doctor in not examining the lens prior to its insertion and has admitted the failure of first surgery on account of opaqueness”.

While Dr. Patel was held negligent, the manufacturer was ordered to pay compensation too.