California implant makers get FDA warnings

Consumer Reports piece on implants sure to charge regulatory environment
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Two Murrieta, CA-based implant makers have been called on the carpet by the FDA for lacking quality control over their manufacturing or assembling processes.

Orthopedic Alliance, which manufactures a total hip system and ceramic ball heads, and Spinal Solutions, which assembles and distributes spinal implant systems and instruments, both received warning letters following FDA inspections of their facilities last summer. The letters were posted on the agency's website this week.

Orthopedic Alliance was criticized for not having a corrective and preventive action (CAPA) procedure. It was also written up for not having a system to resolve ambiguities in purchase orders for hip replacements and other products to guarantee that only the devices approved for release were the ones being sent out. Further, it had no program or personnel designated for resolving complaints.

The FDA wasn't satisfied with the company's response that employees were going to a CAPA seminar in the future and that a complaint program would be established in 60 days.

In the case of Spinal Solutions, the company didn't have procedures to ensure the products it received from suppliers met design criteria or for segregating non-conforming products. Furthermore, it also didn't have a complaint process. Its responses also were rejected as inadequate.

It has to be a difficult time for those devicemakers attempting to convince the FDA their products are safe and sound. For example, there have been lawsuits related to both hip implants and vaginal mesh products over safety issues. Big names, including Johnson & Johnson ($JNJ), are being called on to test products already on the market to ensure their safety. And as the companies fight these battles, they face another hit from Consumer Reports, which Wednesday came out with its first review of medical devices. It is definitely a scathing review that could raise additional congressional concerns about device oversight and regulation.

The Consumer Reports story mentions hip implants, along with gastric Lap-Bands and transvaginal meshes. In particular, the report highlights Allergan's ($AGN) Lap-Bands, which had to be removed from several patients in a study prior to completion because of complications or subjects' failure to lose enough weight.

"Imagine if a car had a recall rate that high," John Santa, director of the Consumer Reports Health Ratings Center, says in the story. "Consumers and regulators would be up in arms. But in the world of medical devices, these things often stay hidden."

- here's the Orthopedic Alliance warning letter
- get the Spinal Solutions warning letter

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