The FDA ordered a Beverly Hills plastic surgeon to stop marketing an implantable pouch that the doctor says can help prevent a nasty side effect for women’s breast augmentations.
Mark Berman has been marketing what he calls the Pocket Protector as a way to prevent the tightening of scar tissue. The pouch is made of two sheets of polytetrafluorethylene held together by silicon rubber cement and Berman uses it to line the inside of a breast pocket of his patients.
The FDA claims that Berman has been advertising the device on his web site with such claims as, “Within three months, there’s no tissue reaction to the material and it is safely incorporated into one’s body essentially as a synthetic scar.” The device hasn’t been approved by the FDA.
The agency’s Feb. 13 letter gave Berman 15 days to cease and desist selling the product. Berman said that he would likely comply but protested that he had done nothing wrong. “A lot of women have been helped by what I do,” he said.
This is Berman’s second go-round with the FDA. Last year, regulators filed for a permanent injunction to shut down his stem cell clinic that authorities say is unlawfully marketing unapproved products.
Read the warning letter here: www.fdanews.com/02-14-19-Berman.pdf. — Bill Myers
How to Write Effective CAPA Reports
A good CAPA report tells a company’s compliance story for four specific audiences: current employees, future employees, regulators and, possibly, lawyers, if a lawsuit eventually results from a product problem.
It’s important to organize CAPA reports and supporting documents in a way that makes them easy to read and follow. Use of short sentences, small words and a lot of white space between paragraphs makes it easier for readers to follow and to get through quickly, which is important to investigators who may be trying to draw conclusions within a relatively short time.
Use headings and subheadings, with just a few paragraphs under each subheading. This, again, allows the reader to skim fairly quickly and get a sense of the level of detail and control in the CAPA investigation and process. Companies can include more detailed and supporting information in appendices so the reader can review them more closely later. The additional information can include charts and graphs.
Some hallmarks of a good report include:
Use of active, rather than passive voice may seem a minor issue. In fact, many companies routinely write their documents in the passive voice. However, use of the passive voice can result in an FDA investigator not understanding the root causes for the failure and not being able to follow the compliance story easily. This can lead to a knee-jerk conclusion that the company is not operating in a state of control, which can, in turn, lead to a closer scrutiny that is bound to turn up additional problems.
Excerpted from the FDAnews management report: Creating QSR-Compliant CAPA Systems: A Practical Guide for Devicemakers.