RAPS recognizes that the current situation in Ukraine impacts our members and customers on many levels. If you are directly impacted by the current situation in the region and are challenged to meet your deadlines or obligations to RAPS, please reach out to raps@raps.org so that we can defer those challenges. Your health and safety are paramount to us.

Regulatory Focus™ > News Articles > 2020 > 8 > FDA qualifies decision tool for breast reconstruction studies

FDA qualifies decision tool for breast reconstruction studies

Posted 21 August 2020 | By Denise Fulton 

FDA qualifies decision tool for breast reconstruction studies

The BREAST-Q Reconstruction Module now is qualified as a medical device development tool (MDDT) to aid sponsors and investigators in developing feasibility, pivotal and post-approval studies of medical devices used in breast reconstruction, the US Food and Drug Administration (FDA) announced.

“An MDDT is scientifically validated and can be qualified for use in device evaluation and to support regulatory decision-making,” according to the announcement, which noted its use is voluntary.

The module’s qualification is a part of the agency’s ongoing efforts to monitor and address serious side effects associated with silicone breast implants.

“The FDA has been diligently monitoring adverse events associated with breast implants for decades and has been working to better understand the quality of life and satisfaction a breast reconstruction patient may experience in order to refine our evaluation of breast implant benefits and risks,” Binita Ashar, MD, director of the Office of Surgical and Infection Control Devices in the Center for Devices and Radiological Health, said in a statement. “Our qualification of the BREAST-Q Reconstruction Module as a validated tool to assess outcomes of breast reconstruction surgery in terms of quality of life and satisfaction helps accomplish this.”

The tool includes several scales, including ones that address Physical Well-Being (Chest), Psychosocial Well-Being, Sexual Well-Being, and Satisfaction with Breasts. The scales aim to quantify the patient’s quality of life and satisfaction with breast reconstruction surgery.

FDA also released updated data on breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) and the pattern of systemic symptoms often referred to as “breast implant illness” or BII that resolve for some patients when the implant is removed.

A total of 733 cases of BIA-ALCL were reported to the FDA through 5 January, including 36 deaths – an increase of 160 cases and three deaths since the data was last released in July 2019, according to the update.
Of the 733 cases, 620 were related to implants from Allergan and 47 involved unknown manufacturers. Almost 500 cases (496) were related to textured implants and 209 did not include information on the surface of the implant. Regarding BIA-ALCL associated deaths, 15 of 16 patients for whom the implant manufacturer was known had Allergan implants at the time of diagnosis.

FDA also released data on medical device reports containing BII-related symptoms from November 2018 through October 2019. Nearly 2,500 reports were made during that period, as compared to just over 1,000 reports from January 2008 through October 2018. The increase likely is caused in part by growing public awareness of BII following an advisory committee meeting addressing the subject in March 2019. (RELATED: FDA Panel Recommends New Postmarket Requirements for Breast Implants, Regulatory Focus 26 March 2019.)

“While there is limited use of the term ‘breast implant illness’ in medical literature, symptoms such as fatigue, memory loss, rash, ‘brain fog’ and joint pain may be associated with breast implants, and some patients and clinicians may use the term ‘breast implant illness’ to describe these symptoms or use these terms when reporting them to the FDA,” the agency said.


© 2022 Regulatory Affairs Professionals Society.