The FDA has come up with a draft guidance list of labeling changes that they recommend be made by breast implant manufacturers to address the safety concerns threatening women all over the world. The recent October 2019 article from The New York Times, “Women Should Be Warned of Breast Implant Hazards, F.D.A. Says”, tells us that “Agency officials said they had ‘heard loud and clear’ that there was ‘a distinct opportunity to do more to protect women who are considering implants.’”
Proposed Label Changes
We learn from the October 23, 2019 FDA Statement, “Statement on the agency’s continued efforts to protect women’s health and enhance safety information available to patients considering breast implants”, that there are five recommendations on the draft guidance list:
The first is a boxed warning which would be a part of the label and would present the risks in a clear, understandable way. The boxed warning would include that,
Breast implants are not lifetime devices; the chances of developing complications increase the longer a patient has the implant and additional surgery may be required to address the complications; and that breast implants have been associated with the risk of developing breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) and may be associated with systemic symptoms (like fatigue or joint pain).
The October The New York Times article states that many women shared that they had no clue of these risks before having their implants put in.
The second is a brochure that includes patient decision checklist that would help provide points of discussion for the patient and surgeon. It would include general information and risks, as well as, giving the patient the opportunity to find out about their surgeon’s “experience, education, training and credentials.”
The October The New York Times article also states that there have been over 70,000 women that signed a petition to demand a checklist from the FDA.
The third is revised rupture screening recommendations. The new recommendations would be that patients without symptoms should be screened five to six years after their implants are put in, by ultrasound or MRI, and then every two years. An MRI should take place for any patient who has symptoms or received uncertain results from an ultrasound.
The fourth is product ingredient information to be included in the label so that patients can clearly and easily understand what is in the implants that they are putting into their bodies.
The fifth is updating previous recommendations concerning patient device cards. There should be more information on these device cards such as,
“…the unique device identifier of the product, the boxed warning, and also provide web links to the patient decision checklist, boxed warning and labeling for the specific implant so that patients may easily access any updated information on the manufacturer’s website.”
FDA’s Efforts to Improve Breast Implant Safety Knowledge
This FDA Statement also includes that,
This draft guidance is just one of several steps we are taking to help women considering breast implants, including issuing warning letters to breast implant manufacturers regarding concerns with their required post-approval studies, convening the panel meeting earlier this year to discuss breast implant safety, and, most recently, requesting that one manufacturer recall its textured breast implant devices from the market due to the risk of BIA-ALCL.
You can refer to some of our previous articles, “March 2019 FDA Meeting On Breast Implants: A Summary Of What You Need To Know” and “U.S. FDA Refrains from Textured Implants Ban”, to learn more about what the FDA discussed at the meeting earlier this year and why they have chosen to take measures other than banning the implants altogether.
As always, we will continue to monitor the issues surrounding breast implants, specifically related to BIA-ALCL, and provide you with any new or relevant information.
Written by: Laura Beasley, Legal Assistant
Law Offices of Thomas J. Lamb, P.A.